PDA Pharmaceutical Microbiology Conference 2025

EDT Daylight Time (UTC -4:00)

• 14:00 – 19:00

  Presenter Ready Room Open

• 14:00 – 19:00

  Registration Open

EDT Daylight Time (UTC -4:00)

• 07:30 – 08:30

  Continental Breakfast

• 07:30 – 16:00

  Presenter Ready Room Open

• 07:30 – 17:30

  Registration Open

• 08:30 – 10:30

  P1: Lessons of Recovery and Resilience: Pharma and the Aftermath of the Hurricane Helene Disaster

  • Moderator:

    

    Erika A. Pfeiler, PhD
    Senior Consultant - Microbiology, ValSource, Inc.

  In September 2024, Hurricane Helene struck North Carolina with devastating force, severely impacting Baxter’s North Cove manufacturing site, one of the nation's key producers of sterile large volume parenteral products. This session offers a compelling, ground-level account of the disaster’s immediate aftermath and the extraordinary efforts to recover a sterile manufacturing facility inundated with mud and debris. Attendees will gain insights into the multi-faceted response, including the critical role of the U.S. FDA in managing drug shortages regardless of their cause. The session will highlight the coordinated efforts among industry, regulators, and public health partners that enabled the rapid restoration of operations and averted a national drug supply crisis.

  • 08:30 – 09:00

    Opening Remarks from Conference Co-Chairs

    • Co-Chair:

      

      Lori Daane, PhD
      Chief Scientific Officer, Bionique Testing Laboratories

    • Co-Chair:

      

      Erika A. Pfeiler, PhD
      Senior Consultant - Microbiology, ValSource, Inc.

  • 09:00 – 09:30

    Deep Dive into Crisis Management: Ensuring Quality and Maintaining Operational Excellence

    • Presenter:

      

      Christiana Bielinski
      Global Head, Quality Compliance, Baxter

  • 09:30 – 10:00

    Drug Shortages: Root Causes and Potential Solutions

    • Presenter:

      

      CDR Emily T. Thakur, RPh
      Team Leader, OCD, CDER, DSS, U.S. FDA

  • 10:00 – 10:30

    Q&A
• 10:30 – 11:15

  Networking Break and Poster Presentations in the Exhibit Hall

• 10:30 – 18:30

  Exhibit Hall Open

• 11:15 – 12:15

  P2: Breaking Biofilms: Reimagining Biofilm Control from the Inside Out

  • Moderator:

    

    Liz Brockson, MPH, VPH
    Aseptic Processing and Sterility Assurance Lead, Takeda

  Biofilms are built to endure, but what if we could take them down from the inside out? This session explores breakthrough research on a universal biofilm matrix component that, when targeted, causes the biofilm structure to collapse. Learn how this novel approach re-sensitizes bacteria to antimicrobials and immune system effectors. The result? A powerful new strategy for disrupting biofilms at their core, opening the door to more effective clinical treatments and a new frontier in biofilm control.

  • 11:15 – 11:45

    Biofilm Busting: The Journey from Bench to Clinic

    • Presenter:

      

      Lauren Bakaletz, PhD
      Professor, The Ohio State University/Abigail Wexner Research Institute at Nationwide Children's Hospital

  • 11:45 – 12:15

    Q&A
• 12:15 – 13:45

  Networking Lunch in the Exhibit Hall

• 13:45 – 15:15

  A1: Comparing Apples to Oranges: When Calibration Standards Fail to Keep Pace with Advanced Technologies for Sterility Testing and Environmental Monitoring

  • Moderator:

    

    Anna F. Lau, PhD, D(ABMM)
    Chief, Sterility Testing Service, National Institutes of Health (NIH)

  Pharma is experiencing a surge of innovative technologies, but implementation often stalls when equivalency between methods is hard to justify. How do you compare genome copies to colony-forming units (CFUs), or CFUs to biofluorescent particles? This session will explore the urgent need for calibration standards and clearer regulatory guidance to support the adoption of advanced microbiological and analytical technologies across the industry.

  • 13:45 – 14:15

    Interlaboratory Evaluation of Eight Different Sterility Testing Methods Using a Standardized Sample Set

    Read more

    Successful implementation of alternative sterility testing methods have been reported on an individual basis; however, comparison of different methods across multiple laboratories using a standard sample set has not yet been assessed. In this study, 11 laboratories evaluated the performance of eight different test methods including growth-based/metabolic systems (n=5; BacT/ALERT, BACTEC, Celsis, Symcel, and USP < 71>) and molecular platforms (n=3; MAT (pyrogens), RNAseq, and Sartorius qPCR). Each laboratory/system combination tested a set of 27 blinded samples that contained 1 of 4 compendial microbes (S. aureus, P. aeruginosa, C. albicans, and A. brasiliensis) at 0, 10, or 100 CFU/mL spiked into 1M CD3+ T-cells/mL in 0.9% saline + 3% human albumin (in triplicate). From a total of 16 data sets, our results showed that viability-based methods (n=10) and RNAseq (n=1) had high sensitivity, specificity, accuracy and reproducibility. In contrast, false positives and poor specificity were observed with MAT (n=1) and qPCR (n=4). Additional evaluation is underway to identify the source of contaminating LPS and exogenous DNA, which may be related to research- vs. clinical-grade materials. This study highlights that study materials must be fit for purpose and may not perform uniformly across different test platforms.

    • Presenter:

      

      Jason Kralj, PhD
      Staff Researcher, NIST

  • 14:15 – 14:35

    A Universal Methodology for Calibrating Biofluorescent Particle Counters Using Real Microorganisms

    Read more

    The adoption of biofluorescent particle counters (BFPCs) for real-time viable air monitoring is rapidly expanding across the pharmaceutical industry. However, despite their growing implementation, there is currently no standardized guideline or regulatory framework defining how these instruments should be calibrated to verify their performance for the intended use. To ensure metrological traceability with current standards, such as EN 17141:2020 and EN ISO 14644-1:2015, we present a method of BFPCs testing with airborne microbiological particles. This presentation introduces this universal methodology for the periodic calibration of BFPCs, aiming to close a critical gap in current practice. To ensure that the viable particle tested will have no effect on the sterility during normal operation, a vaporized hydrogen peroxide (VHP) decontamination is proposed as a part of this procedure. By demonstrating the feasibility of routine calibrations with real viable particles, this methodology provides a practical framework for verifying instrument performance over time. The simplicity of the proposed procedure enables existing laboratories that qualify and calibrate active air samplers to apply it easily. Ultimately, the goal is to support end users, regulatory bodies, and manufacturers in unifying calibration practices and establishing reliable, science-based standards for BFPC periodic verification.

    • Presenter:

      

      Svetlana Kiseleva, PhD
      Chief Product Officer, Plair SA

  • 14:35 – 15:15

    Q&A
• 13:45 – 15:15

  B1: Unlocking the Secrets to Environmental Monitoring Trending and Microbial Data Deviations: Harmonized Practices and Advanced Root Cause Analysis

  • Moderator:

    

    Dawn M. Watson
    Executive Director, Micro Quality & Sterility Assurance, Merck & Co., Inc.

  This session will examine how the industry is moving toward more consistent approaches to environmental data analysis and microbial investigations. Attendees will explore current guidance on trending expectations, learn when and how to evaluate data, and review a case study highlighting innovative tools used to uncover complex contamination sources often missed by traditional methods.

  • 13:45 – 14:15

    Review of Industry Practices for Environmental Monitoring Trending Highlights the Need for Industry Harmonized Guidance

    Read more

    Trending of environmental monitoring (EM) data, as part of a holistic EM program, is a regulatory requirement and enables continuous evaluation of the effectiveness of contamination control as outlined in a Contamination Control Strategy. Although EM trending is a regulatory requirement, there is a lack of industry-standardized guidance on the methodology, frequency, and trend response used for both routine and event-driven EM trending. An industry survey was conducted to understand the variability of the EM trending practices and to identify best practices and principles for the pharmaceutical industry to follow. The survey results will be reviewed; and points to consider to be included in an industry guidance document on EM trending will be discussed. This presentation will review the survey results and the industry guidance which is being developed on this topic. The guidance will encompass WHAT data to review, HOW to interpret the data and WHEN to perform EM trending to analyze if the respective manufacturing areas are in a state of control.

    • Presenter:

      

      Christine Caruso
      Associate Director, Microbiological Quality & Sterility Assurance, Merck & Co., Inc.

  • 14:15 – 14:45

    The Case of the Missing Root Cause: When Fishbone Diagrams Aren’t Enough for Microbial Data Deviations

    Read more

    Microbial data deviations such as sterility test failures and environmental monitoring (EM) trend excursions are often difficult and time consuming to investigate. In many instances, a “smoking gun” root cause cannot be identified, and investigators are left with a list of potential root causes to address in the hope that the issue will be resolved. Currently, the most commonly used root cause analysis tools for such investigations are the Fishbone Diagram paired with a 5 Whys approach. These tools work well for brainstorming and for investigating one-off events, however, they frequently fall short when investigating adverse trends or more complex situations. This presentation will introduce Event and Causal Factor Charting, an advanced root cause analysis tool that is useful for multifaceted and complicated situations where multiple root causes and causal factors are possible. A case study of an EM adverse trend investigation will show how the Fishbone Diagram approach led the investigative team to incomplete understanding of the root cause, whereas subsequent use of the Event and Causal Factor Charting exercise identified multiple systemic root causes that were previously missed.

    • Presenter:

      

      Amanda Curtis
      Microbiology Consultant, ValSource, Inc.

  • 14:45 – 15:15

    Q&A
• 13:45 – 15:15

  C1: Bio-Decontamination in Focus: Enhancing Vaporized Hydrogen Peroxide Validation and Control for Aseptic Environments

  • Moderator:

    

    Daniel Bice
    Associate Director Microbiologist Quality Compliance, Teva

  Discover the latest advancements in vaporized hydrogen peroxide (VHP) bio-decontamination. This session will tackle critical challenges, such as rogue biological indicators that compromise validation reliability, and explore VHP’s effectiveness against resilient lyophilized biohazards. Hear from industry experts as they share innovative strategies and models to strengthen contamination control in aseptic isolators and advanced therapy manufacturing.

  • 13:45 – 14:15

    The Hidden Threat in VHP Cycle Validation: Quantifying the Impact of Rogue/Late-Positive Biological Indicators Using Statistical Models and Monte Carlo Simulations

    Read more

    Spore-based biological indicators (BIs) are critical for validating vaporized hydrogen peroxide (VHP)-based decontamination cycles, offering a robust measure of microbial inactivation. However, the presence of "rogue" or "late-positive" BIs that resist to the VHP sporicidal effect beyond expected levels, can lead to false-positive results, potentially compromising the reliability of validation protocols. This presentation explores the “rogue” dynamics and the statistical impact of rogue BIs within Performance Qualification (PQ) procedures for aseptic isolators using VHP. By modeling the PQ rules mathematically, the study quantifies how even a low incidence of rogue BIs can exponentially increase the probability of PQ failure. Three key PQ criteria are analyzed: (A) the presence of multiple positive BIs in a single location, (B) exceeding a pre-defined threshold of positive locations (e.g. 5%), and (C) recurrence of positive results in the same location across cycles. The analysis demonstrates that a rogue BI mean rate exceeding 0.3% significantly elevates the risk of PQ failure, even in otherwise effective decontamination cycles. A Monte Carlo testing approach is used to provide realistic failure probabilities, highlighting the need for BIs batch rogue-tests or alternative mitigation strategies. The proposed methodology serves as a predictive tool to optimize validation protocols and ensure successful qualifications of aseptic isolators.

    • Presenter:

      

      Giacomo Guidi, MEng
      Aseptic Process Expert & Strategic Marketing, IMA LIFE

  • 14:15 – 14:45

    Applicability of VHP for Contamination Control of Lyophilized Biohazards

    Read more

    Biologics and advanced therapy medicinal products (ATMPs) are often lyophilized to maintain stability, but this form complicates post-production decontamination, particularly when hazardous materials are involved. Vaporized hydrogen peroxide (VHP) is widely used for surface decontamination and is considered a promising method for post-production decontamination due to its ability to degrade biohazards into nontoxic byproducts. However, its efficacy against lyophilized residues remains uncertain. This study investigates the effectiveness of VHP decontamination for lyophilized biologics and ATMPs by examining the impact on lyophilized Geobacillus stearothermophilus and formulation composition using pharmaceutically relevant matrices. The results reveal challenges in inactivation of lyophilized drug products and propose an isolator design solution to mitigate these limitations, supporting safe handling and robust contamination control in the manufacture of lyophilized biologics and ATMPs.

    • Presenter:

      

      Hussein Bachir, PhD
      Scientist - GMP Compliance, Franz Ziel GmbH

  • 14:45 – 15:15

    Q&A
• 15:15 – 16:00

  Networking Break and Poster Presentations in the Exhibit Hall

• 16:00 – 17:30

  A2: Conquering Microbial Contamination: Case Studies and Predictive Models in Drug Manufacturing

  • Moderator:

    

    Kurt Jaecques, MA
    Global Quality Technical Senior Lead, GSK

  Unlock innovative strategies to tackle microbial ingress in pharmaceutical manufacturing. This session will cover effective remediation techniques for Gram-positive spore-forming organisms and demonstrate how predictive models harness data to prevent future microbial events, ensuring robust and reliable manufacturing processes.

  • 16:00 – 16:30

    ProA Paenibacillus Microbial Trend and Resolution: A Case Study

    Read more

    Struggles with microbial ingress at the ProA step of Drug Substance manufacturing is a known issue in the industry due to the manufacturing process and sensitivity of the ProA resin to strong sanitization solutions. In particular, microbial ingress of Gram positive rods, spore-forming organisms has been seen including but not limited to Paenibacillus species. Effective microbial remediation is a concern due to the resin sensitivity and the complexity of the manufacturing equipment to ensure full elimination of the microorganism from the equipment and resin. Spore-forming Gram positive organisms are more resilient and require a stronger sanitization solution to be effective against these organisms. However, use of a stronger solution can result in a negative impact to the resin lifetime. Can resin in contact with equipment exposed to microorganisms be remediated and still functional? The case study will demonstrate the ability to remediate resin exposed to spore-forming Gram positive organisms and still functional.

    • Presenter:

      

      Beth Kirschenheiter
      Associate Director, MS&T, Bristol Myers Squibb

  • 16:30 – 16:50

    A Global Approach for Preventing Microbial Events through a Predictive Model

    Read more

    We have access to a large amount of data in pharmaceutical manufacturing that could support a predictive model in identifying areas of risk associated with microbial contamination events. While we have this information, past performance does not always predict the future, especially as it relates to microbial events. There is often a complex set of circumstances that leads to failure. With this in mind, this presentation will consider a case study where data, patterns/trends, specific signals and subject matter expert input were utilized to make predictions for where there might be a higher risk for a future micro related event. The presentation will provide an overview of how a global approach was used to conduct the assessment, the high-level outcomes and the proposed mitigations based on the outcomes. The presentation will also include the challenges that were encountered throughout the process and considerations for implementation of this assessment as a sustainable global business process.

    • Presenter:

      

      Dawn M. Watson
      Executive Director, Micro Quality & Sterility Assurance, Merck & Co., Inc.

  • 16:50 – 17:30

    Q&A
• 16:00 – 17:30

  B2: Advancing Advanced Therapy Medicinal Products: Navigating Control Strategies and Facility Innovation

  • Moderator:

    

    Frederic B. Ayers
    Senior Consultant - Microbiology, ValSource, Inc.

  As ATMP manufacturing evolves, so do the challenges of maintaining product quality and operational efficiency. This session will explore practical strategies for contamination control and facility design, showcasing how leading companies are meeting the unique demands of ATMPs through strategic planning, risk-based approaches, and innovative facility solutions.

  • 16:00 – 16:30

    Challenges of Developing a Contamination Control Strategy for ATMPs: Insider Insights

    Read more

    Contamination control is a critical aspect of manufacturing Cell and Gene Therapies (ATMPs), and the design and implementation of a Contamination Control Strategy (CCS) are vital to ensuring product safety and compliance. This presentation, led by a former ATMP industry insider, will focus on the challenges associated with preventing and managing contamination during the production of advanced therapies. Contamination risks - ranging from microbial and particle contamination to cross-contamination between products - pose significant threats to both product integrity and patient safety. A robust CCS must address these risks through a holistic combination of controls however, one of the most critical aspects of an effective CCS is the training of operators. While human error isn’t a challenge specific to ATMP, the impact from poor operator behaviors has a compounding effect when manufacturing an aseptic product that lacks terminal sterilization. This presentation will share real-world examples where contamination risks were identified and mitigated, provide insights into developing a culture of contamination control, and offer practical insights on best practices for contamination control in ATMP.

    • Presenter:

      

      Patricia Igneczi
      Senior Technical Services Specialist, Contec, Inc.

  • 16:30 – 17:00

    ATMP Facilities: Evolving with the Sciences

    Read more

    Viral Vector (VV) - based advanced therapy medicinal products (ATMPs) have been commercially manufactured for over a decade. Facilities for manufacturing ATMPs have evolved, while keeping up with the science behind these therapies advancing at a remarkable pace. This evolution has significantly influenced the design of manufacturing facilities tailored to ATMP production. This presentation examines three case studies illustrating how facility design has transformed in response to the growing complexity of these therapies and their manufacturing processes. Through these examples, this presentation highlights innovations in facility design that address the unique challenges posed by increasingly sophisticated VV-based ATMPs. By exploring these advancements, the presentation showcases how facility design continues to adapt and evolve to meet the demands of an ever-changing therapeutic landscape. The presentation will discuss sustainability elements of facilities as well. *** This presentation can be extended to 30 minutes if desired by the PDA committee.***

    • Presenter:

      

      Ankur K. Shah, PE
      Lead Process Engineer, Arcadis

  • 17:00 – 17:30

    Q&A
• 16:00 – 17:30

  C2: PDA Technical Report Updates

  • Moderator:

    

    Josh Eaton, MS
    Senior Director, Scientific and Regulatory Affairs, PDA

  The pharma industry has long relied on Technical Report 22: Aseptic Process Simulation and Technical Report 33: Alternative Microbiological Methods to ensure product safety and regulatory compliance. Join the co-leads behind the recent revisions of these essential reports to learn about the latest updates and how they impact industry practices.

  • 16:00 – 16:30

    TR 22: Aseptic Process Simulation

    • Presenter:

      

      Marcia C. Baroni, MBA
      VP Quality, Enterprise GxP Compliance & Systems, Emergent BioSolutions

  • 17:00 – 17:30

    Q&A with Additional Panelists

    • Panelist:

      

      Vanessa A. Figueroa, MA
      Chief Microbiologist, VVF Science

• 17:30 – 18:30

  Networking Reception in the Exhibit Hall

EDT Daylight Time (UTC -4:00)

• 08:00 – 09:00

  Continental Breakfast

• 08:00 – 16:15

  Presenter Ready Room Open

• 08:00 – 17:45

  Registration Open

• 09:00 – 10:15

  P3: The Path to Discovery of the Hepatitis C Virus

  • Moderator:

    

    Anna F. Lau, PhD, D(ABMM)
    Chief, Sterility Testing Service, National Institutes of Health (NIH)

  Join us for an inspiring plenary session with Dr. Harvey Alter, recipient of the 2020 Nobel Prize in Physiology or Medicine for his groundbreaking discovery of the Hepatitis C virus. Dr. Alter will reflect on his extraordinary career, sharing the triumphs he’s achieved, the challenges he’s faced, and the pivotal moments that shaped his path. He will also share insights and lessons he believes are most important for building the next generation of scientists.

  • 09:00 – 09:45

    Hepatitis C: The End of the Beginning and Possibly the Beginning of the End

    • Presenter:

      

      Harvey J. Alter, MD
      Distinguished NIH Scholar, Emeritus, National Institutes of Health (NIH)

  • 09:45 – 10:15

    Q&A
• 10:15 – 11:00

  Networking Break and Poster Presentations in the Exhibit Hall

• 10:15 – 16:15

  Exhibit Hall Open

• 11:00 – 12:30

  A3: Microbial Compliance in Focus: Regulatory Trends and Enforcement Insights in Sterile Processing

  • Moderator:

    

    Erika A. Pfeiler, PhD
    Senior Consultant - Microbiology, ValSource, Inc.

  As regulatory expectations for microbial contamination control evolve, staying ahead of compliance challenges is essential. This session will feature experts discussing current guidance and enforcement trends affecting Blow-Fill-Seal (BFS) technology and 503B outsourcing facilities, with valuable insights drawn from recent U.S. FDA observations.

  • 11:00 – 11:30

    Evolving Regulatory Expectations for Microbial Contamination Control in Blow-Fill-Seal (BFS) Technology

    Read more

    Blow-Fill-Seal (BFS) technology has become an integral part of aseptic manufacturing, offering a highly automated and efficient method for producing sterile liquid pharmaceuticals. However, evolving regulatory expectations, driven by advancements in contamination control strategies and updated global guidelines, continue to reshape the landscape of BFS manufacturing. In this session, we will explore existing regulatory frameworks and available guidance with a specific focus on microbial contamination control in BFS processes, including the revised EU GMP Annex 1, the FDA's 2004 Aseptic Processing Guidance, and PDA Technical Report No. 77. Additionally, case studies of recent FDA Form 483 observations related to BFS manufacturing will be examined, highlighting common compliance gaps and regulatory concerns. By analyzing these real-world examples, we will discuss proactive contamination control measures and strategies to ensure BFS operations meet evolving regulatory expectations while maintaining product sterility and quality.

    • Presenter:

      

      Julia Marre, PhD
      Regulatory Affairs, Principal Consultant, NSF

  • 11:30 – 11:50

    Looking at the Past to Plan for the Future: Microbiology Regulatory Inspection and Enforcement Trends in 503B Outsourcing Facilities

    Read more

    In recent years, regulatory oversight of 503B outsourcing facilities has intensified, particularly in the area of microbiology, as the FDA continues to emphasize the critical importance of contamination control in sterile compounding. This presentation will explore current inspection and enforcement trends, highlighting the most frequently cited microbiology-related observations from FDA Form 483s and warning letters. Key focus areas include environmental monitoring program deficiencies, improper incubation practices, inadequate investigation of microbial excursions, failure to trend data effectively, and weaknesses in media fill and gloved fingertip testing documentation. Attendees will leave with a clearer understanding of evolving regulatory expectations, practical takeaways for improving compliance, and insight into how microbiological practices directly influence enforcement outcomes in the 503B landscape.

    • Presenter:

      

      Abby A. Roth, CMQ/OE
      Owner/Microbiologist, Pure Microbiology, LLC

  • 11:50 – 12:30

    Q&A
• 11:00 – 12:30

  B3: Progressive Recombinant Endotoxin Test Deployment and Navigating Low Endotoxin Recovery Regulatory Uncertainties

  • Moderator:

    

    Jay Bolden
    Senior Director, Eli Lilly and Company

  Delve into two critical topics shaping the future of endotoxin testing. This session will explore the benefits and practical implementation of recombinant bacterial endotoxins tests (rBET), as well as the complexities of Low Endotoxin Recovery (LER) studies. Attendees will gain valuable insights into regulatory considerations, technical challenges, and strategies for navigating inconsistent expectations across the industry.

  • 11:00 – 11:25

    Harmonizing Endotoxin Testing: Global Implementation of Recombinant Factor C for Sustainable Endotoxin Testing

    Read more

    Endotoxin testing is critical for ensuring the quality of parenteral pharmaceutical products. Traditional Limulus Amebocyte Lysate (LAL) assays, derived from horseshoe crab hemolymph, raise sustainability concerns. Recombinant Factor C (rFC) offers a validated, sustainable alternative, enhancing supply chain resilience and species conservation. Roche is implementing a global transition to rFC for endotoxin testing to secure supply, protect horseshoe crabs, and assure product quality. This presentation will detail Roche’s rFC validation process and strategic implementation for pharmaceutical water and product testing. The primary focus will be on the global deployment strategy post-validation, including the current implementation status, protocols for technology transfer to new manufacturing sites, regional and regulatory adaptations, risk mitigation, personnel training, technical support, and methods for ensuring inter-site consistency. Insights and practical guidance will be provided on scaling rFC testing for clinical and commercial biologic product batches. This presentation will share lessons learned, address technical challenges, and offer solutions for the effective and harmonized adoption of rFC testing across international manufacturing facilities.

    • Presenter:

      

      Evelyn Der, RM, SM, CQA, CPGP
      Senior Scientist QC, Genentech

  • 11:25 – 11:50

    Regulatory Challenges of Recent Low Endotoxin Recovery Regulatory Queries: Pfizer’s Strategy to Evaluate and Implement Global Changes to Meet Evolving Expectations

    Read more

    The frequency and scope of inquiries related to Low Endotoxin Recovery (LER) from health authorities for biotherapeutic product submissions have dramatically increased over the past year. LER studies are required by the Center of Drug Evaluation and Research (CDER) – Food and Drug Administration (FDA). The Parenteral Drug Association (PDA) Technical Report (TR) No. 82, Low Endotoxin Recovery, is used as a guidance for performing LER studies for Biologics License Application (BLA) submissions to CDER, although some recent queries diverge from PDA TR 82. In September 2023, the European Medicines Agency (EMA) published Questions and Answers on biological medicinal products, containing the question, “When should Low Endotoxin Recovery (LER, also known as “endotoxin masking) be investigated?”. The provided answer to this question does not specifically define LER or offer detailed instructions on study methodologies. Due to the increase in queries, an assessment of the queries in a trackable database was completed. This presentation will highlight the major themes observed in these queries, particularly those that had tangible impacts on our LER strategy.

    • Presenter:

      

      Jody Peraino, MS
      Principal Scientist, Pfizer

  • 11:50 – 12:30

    Q&A
• 11:00 – 12:30

  C3: From Standards to Solutions: Enhancing Microbial Control with USP’s Latest Chapters

  • Moderator:

    

    Lori Daane, PhD
    Chief Scientific Officer, Bionique Testing Laboratories

  Get ahead of the curve in microbiological quality standards. Hear directly from the USP Microbiology Expert Committee as they provide key updates to newly approved and revised chapters and share what’s on the horizon. This session wraps up with a dynamic panel discussion—your opportunity to connect with USP experts, ask technical questions, exchange ideas, and gain exclusive insight into the future of microbial quality.

  • 11:00 – 11:30

    Overview and In-Depth Discussion of Chapters <1119> and <1119.1>

    • Presenter:

      

      Edward C. Tidswell, PhD
      Executive Director QA, Merck & Co., Inc.

  • 11:30 – 12:00

    Updates on Rapid Microbiological Methods (RMM) Chapters, Including <1071>, <72>, and <73>

    • Presenter:

      

      Anna F. Lau, PhD, D(ABMM)
      Chief, Sterility Testing Service, National Institutes of Health (NIH)

  • 12:00 – 12:30

    Q&A with Additional Panelists

    • Panelist:

      

      Leslie A. Furr, MS
      Principal Scientist, USP

    • Panelist:

      

      Huiping Tu, PhD
      Senior Principal Scientist, USP

• 12:30 – 14:00

  Networking Lunch in the Exhibit Hall

• 14:00 – 15:30

  A4: Global Strategies for Validating and Implementing Alternative Microbiological Methods: Insights and Lessons Learned

  • Moderator:

    

    Lori Daane, PhD
    Chief Scientific Officer, Bionique Testing Laboratories

  Discover how two global biopharmaceutical companies validated and implemented innovative microbiological technologies: a pouch-based multiplex PCR for rapid mycoplasma detection and an automated colony counter for environmental monitoring. Learn about their validation strategies, regulatory hurdles, IT integration, and key lessons from deployment across diverse product types and international sites.

  • 14:00 – 14:30

    Global Implementation of Novel Microbial Technology Across BMS Enterprise

    Read more

    Compendial growth-based mycoplasma testing is generally outsourced due to the requirements for 1) use of live mycoplasma (a risk to a manufacturing site) and 2) highly skilled analysts capable of microscopic examination of fluorescent stained mycoplasma cultures. Compendial testing also has a minimum of 28-day time to result, which is not feasible for a short shelf-life product. To this end, BMS has begun global implementation of a new rapid mycoplasma test methodology using a pouch based multiplex PCR technology. BMS will implement this technology for both cell therapy and biologics, and across five total sites. As part of this initiative, universal, product-agnostic methods and global trainings have been developed specific to each modality and technology transfers are currently in progress from the Microbiology Center of Excellence to each of the five manufacturing sites in support of both clinical and commercial products. This presentation will speak to lessons learned in implementing a new technology for a non-compendial microbiological method with an enterprise mindset, as BMS moves to streamline operations and optimize processes to enable sites to move to multi-product operations more efficiently.

    • Presenter:

      

      Aimee L. Cunningham, PhD, MPH
      Associate Director, Bristol Myers Squibb

  • 14:30 – 15:00

    A Global Approach to New Technology Introduction and Validation: Automated Colony Counting

    Read more

    In this case study, we present our approach to the global validation and introduction of an alternative microbiological method. We will describe how we have industrialized and introduced a automated colony counting technology for large volume environmental monitoring QC laboratories. The workflow allows for “walk away” processing of samples following incubation, where the instrument scans the sample barcode, reads the result, enters the count into LIMS and processes the agar plate for further analysis or discard. The APAS Independence from Clever Culture Systems was chosen and validated in one location as part of a global validation strategy to introduce the system at multiple locations within AstraZeneca Here we present the approach to industrialization, global validation, IT system integration as well as the project learnings and workflow development. We will share the realized benefits and how a global approach to technology introduction can used to streamline the modernization of pharmaceutical microbiology.

    • Presenter:

      

      Phil Duncanson, PhD
      Senior Director, AstraZeneca

  • 15:00 – 15:30

    Q&A
• 14:00 – 15:30

  B4: Digital Integrity and Intelligent Automation: Microbial Quality in the Modern Age

  • Moderator:

    

    Julia Marre, PhD
    Regulatory Affairs, Principal Consultant, NSF

  Discover how digital innovation and AI are advancing microbiological quality control. This session will present risk-based strategies for ensuring data integrity in GxP environments and a case study on AI-driven colony counting for environmental monitoring and bioburden testing. Learn how to align innovation with compliance to improve contamination control using automation and analytics.

  • 14:00 – 14:30

    Mastering Data Integrity in the Digital Age: A Risk-Based Path to GxP Excellence

    Read more

    The digital transformation of pharmaceutical manufacturing presents both opportunities and challenges in ensuring data integrity, a foundational element of Good Manufacturing Practice (GxP) compliance. As automated systems, advanced analytics, and interoperable digital tools become integral parts of operations, so too does the risk of vulnerabilities in data. This presentation covers the overall framework for mitigating these risks using a risk-based approach to data governance and integrity management. Key topics will include building resilient data governance frameworks, leveraging automation for proactive monitoring, and ensuring data traceability throughout the product lifecycle. Practical case studies will demonstrate how risk-based strategies enhance compliance, drive operational efficiency, and align with regulatory expectations, such as those of the FDA, EMA, and global Good Manufacturing Practice (GxP) standards. This session bridges the gap between compliance and digital innovation, equipping attendees with actionable strategies to protect data integrity while optimizing manufacturing processes. Whether you are involved in quality assurance, regulatory affairs, or manufacturing science, this presentation will empower you to navigate the complexities of the digital age with confidence.

    • Presenter:

      

      Peniel Ortega, PMP
      Managing Director, PharmAllies

  • 14:30 – 14:50

    Suitability Evaluation of an AI-Driven Automated System for Colony Counting in Environmental Monitoring and Bioburden Testing

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    The pharmaceutical industry is undergoing a paradigm shift—from manual, reactive microbiological quality control to automated, proactive strategies powered by data and intelligent systems. In this evolving landscape, ensuring the reliability and efficiency of advanced technologies is essential to maintaining high standards in product safety and regulatory compliance. This study presents the results of a two-phase suitability evaluation of an automated system that integrates incubation, continuous reading, and AI-based colony counting for microbiological quality control, with specific application in environmental monitoring (EM) and bioburden testing. The evaluation was conducted both at the supplier’s microbiology laboratory and at a major Swiss pharmaceutical company, providing a comprehensive assessment in different operational contexts. Key performance indicators were analyzed to compare the AI software’s output with traditional manual methods. Continuous monitoring of colony growth offers significant advantages. It enables more accurate and consistent quantification compared to conventional techniques, while also supporting the early detection of microbial growth. This allows for faster implementation of corrective actions when threshold values are exceeded, ultimately contributing to more robust contamination control strategies.

    • Presenter:

      

      Camilla Giardini
      Project Manager, Copan Newlab

  • 14:50 – 15:30

    Q&A
• 14:00 – 15:30

  C4: Advancing Microbial Control: Efficacy, Validation, and Risk-Based Approaches in Pharmaceutical Cleaning

  • Moderator:

    

    Daniel Bice
    Associate Director Microbiologist Quality Compliance, Teva

  Explore risk-based strategies for microbial control in pharmaceutical settings. This session will showcase advances in disinfectant efficacy validation and approaches for managing bioburden on non-sterile manufacturing equipment, supporting robust cleaning programs and regulatory compliance

  • 14:00 – 14:30

    The Future of Disinfection Efficacy Testing: Aligning Validation to Regulatory Landscapes

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    Disinfectant Efficacy Testing is a well-established area of microbiological testing to determine effect of biocides against microbial contamination. With focus on modern regulatory requirements and guidelines, validation of biocides within the pharmaceutical industry has become more prudent. Expectations to validate in the specific manner in which a biocide is used should be considered. This presentation will revisit some of the traditional microbiological standards for biocidal assessment and the development of this testing to better reflect biocide use in a pharmaceutical manufacturing environment. The development of disinfectant wipe efficacy assessment will be discussed in accordance with best practice techniques. This presentation will also highlight the validation process beyond laboratory testing with guidance and recommendation on in-situ, also known as ‘Phase III’, assessment.

    • Presenter:

      

      David J. Collins
      Principal Global Technical Consultant, Ecolab Life Sciences

  • 14:30 – 14:50

    Microbial Control for Nonsterile Manufacturing Equipment Product-Contact Surfaces

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    There is an understanding of how cleaning processes for pharmaceutical equipment used in aseptic operations are implemented not only for controlling drug product cross-contamination, but also for the initial reduction in bioburden prior to sterilization. However, there is limited guidance on bioburden limits for product-contact surfaces of equipment used to manufacture non-sterile products. This lack of information and regulatory requirements prompts questions on whether it is necessary to have a separate sanitization or disinfection step after cleaning of equipment product-contact surfaces for nonsterile drug manufacturing. Per USP < 1115>, microbial limits and the design for cleaning and other associated processes should be based on risks assessed and the level of control necessary based on the product. It would be beneficial to implement processes that can address both product residual and microbial contamination of equipment surfaces. Multiple factors play into the design of an effective and efficient cleaning process. When adequate controls are implemented for the cleaning process and its associated factors, a separate sanitization or disinfection process may not be needed for product-contact surfaces when data is able to demonstrate that the cleaning process and the other preventive measures are able to control microbial contamination of those surfaces.

    • Presenter:

      

      Antonio F. Ortiz, MS
      Technical Services Manager, STERIS Corporation

  • 14:50 – 15:30

    Q&A
• 15:30 – 16:15

  Networking Break, Poster Presentations, and Passport Drawing in the Exhibit Hall

• 16:15 – 17:45

  A5: Live Bugs and Fast Facts: Microbial Quality for Modern Biologics

  • Moderator:

    

    Julia Marre, PhD
    Regulatory Affairs, Principal Consultant, NSF

  Navigate microbial quality challenges in today’s complex biologics landscape. This session will explore quality frameworks for injectable live microbial products and rapid, hybrid mycoplasma testing for cell and gene therapies Learn how to meet regulatory expectations and accelerate product release with confidence.

  • 16:15 – 16:40

    Quality Frameworks for Injectable Live Microbial Products (LMP): What the LMP Field Can Learn from ATMPs

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    Injectable Live Microbial Products (LMPs) present unique challenges in manufacturing, quality control, and regulatory compliance due to their reliance on living microorganisms as active ingredients. These challenges, including maintaining viability, ensuring monoseptic conditions, and addressing sterility requirements, parallel many of the complexities encountered in the development of Advanced Therapy Medicinal Products (ATMPs). This presentation explores the shared quality frameworks between LMPs and ATMPs, focusing on critical areas such as aseptic manufacturing, control of raw materials, identification of critical quality attributes (CQAs), and batch-specific release testing. By drawing on lessons learned from ATMPs, including strategies for managing analytical challenges, reducing manufacturing times, ensuring microbial contamination control, as well as compliance to the Annex 1 from EudraLex Volume 4, and navigating regulatory uncertainty, this work provides actionable insights to support the development and commercialization of LMPs. Leveraging these parallels can help establish robust quality systems for LMPs, ensuring safety, efficacy, and compliance with evolving regulatory standards.

    • Presenter:

      

      Moira M. Schuler
      Global CMC Manager, Wacker Biotech US

  • 16:40 – 17:05

    Strategy and Case Studies for Demonstrating Product-Specific Suitability of a Rapid Hybrid Testing Approach for Mycoplasma Detection

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    Cell and gene therapy sponsors often require shorter time to results for mycoplasma release tests than growth-based compendial methods can support. Although PCR-based methods can achieve shorter turnaround times with lower test sample volumes, they may experience test article matrix interference. Including an enrichment period prior to PCR analysis, known as a hybrid testing approach, can mitigate this interference and increase sensitivity. Hybrid methods also facilitate sampling additional timepoints. This enables the determination of optimal incubation periods, result verification, and discrimination between viable and non-viable contaminations. This hybrid testing approach was first demonstrated to consistently detect mycoplasma, including a traditionally non-cultivable species, in representative matrices of CHO and Jurkat cells at 1e6 cells/mL. This provided confidence in proceeding with product-specific suitability studies. Alternative method validation requirements are described in USP < 1223>, with mycoplasma-specific guidance detailed in EP 2.6.7, and JP . However, cell and gene therapy products often face unique constraints when conducting these suitability studies. This presentation discusses strategies to address the parameters required to demonstrate product-specific suitability of this hybrid testing approach, including overcoming limited product availability and turnaround time constraints, minimizing matrix interference, leveraging platform validation data, and establishing comparability to the compendial method.

    • Presenter:

      

      Kevin Susice, MS
      Project-Based Scientist, Bionique Testing Laboratories

  • 17:05 – 17:45

    Q&A
• 16:15 – 17:45

  B5: Contamination Control Strategies in Action: Real-World Tools and Mindsets That Deliver Results

  • Moderator:

    

    Liz Brockson, MPH, VPH
    Aseptic Processing and Sterility Assurance Lead, Takeda

  See contamination control in action. This session will explore a practical, team-driven CCS framework and a compelling case study on how cultural change can elevate contamination control, build resilience, and drive measurable quality improvements.

  • 16:15 – 16:45

    The CCS Advantage: Elevating Patient Safety Through an Infinite Mindset

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    The 2024 PDA Annex 1: One Year into Implementation Survey participants highlighted the Contamination Control Strategy (CCS) as the most beneficial change for the industry. Respondents also ranked the CCS among the top five areas of interest during inspections, while noting that health authorities have varying interpretations of the CCS. Additionally, the implementation of the periodic review (Section 2.6) has raised challenges within the industry. The rapidly evolving pharmaceutical manufacturing landscape require that a firm’s comprehensive Contamination Control Strategy ensure patient safety and operational excellence. This podium presentation will explore the dynamic interaction between two critical components, address immediate contamination risks through a robust CCS and advance a culture of continuous improvement through the Infinite Mindset. Implementation of the Infinite Mindset principals with a comprehensive CCS creates an environment that proactively manages contamination risks and prioritizes product quality. The case study that will be presented will demonstrate how the adoption of an Infinite Mindset will enhance the effectiveness of the CCS while fostering resilience and innovation. When performed successfully, adoption of the Infinite Mindset within the CCS will enhance manufacturing processes, personnel motivation, product quality, and patient safety.

    • Presenter:

      

      Frederic B. Ayers
      Senior Consultant - Microbiology, ValSource, Inc.

  • 16:45 – 17:15

    No More Guesswork: Practical Tools for a Better CCS

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    Developing a contamination control strategy (CCS) requires structured planning, active collaboration, and a strong link to quality risk management. This presentation outlines a stepwise, real-world approach to building a CCS that reflects both regulatory expectations and practical implementation within a manufacturing environment. We begin by establishing a cross-functional team representing Facilities, Equipment, Utilities, Operations, and Quality. The team creates a working spreadsheet organized by functional area to catalog key principles and map existing controls. This tool also tracks percent compliance to Annex 1 requirements, providing a measurable way to gauge internal progress and the evolving maturity of aseptic processing systems. Each group identifies and gathers relevant documents—risk assessments, validation master plans, procedures, and process documents in order to assess current state. We extract and evaluate relevant controls by functional group and describe them in a draft of the CCS document. Visuals illustrate the interconnection between controls, their associated validation activities, and monitoring programs. The CCS also defines how contamination events are managed, including expectations for periodic review and updates. Where gaps in control are identified, they are escalated to a formal quality plan for remediation. This results in a dynamic, risk-based CCS framework that supports continuous improvement and inspection readiness.

    • Presenter:

      

      Vanessa A. Figueroa, MA
      Chief Microbiologist, VVF Science

  • 17:15 – 17:45

    Q&A
• 16:15 – 17:45

  C5: Sterilization Challenges and Environmental Monitoring: Navigating EU Annex 1 Compliance

  • Moderator:

    

    Kurt Jaecques, MA
    Global Quality Technical Senior Lead, GSK

  Explore effective strategies for sterilizing indirect product-contacting parts in line with the new EU Annex 1. This session will examine particle and microbial transport dynamics in isolators through best practices, case studies, and computational fluid dynamics insights.

  • 16:15 – 16:45

    Sterilization Validation and Indirect Product Contacting Parts

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    With the implementation of the new version of EU Annex 1, many medicinal product manufacturers have questions regarding handling of indirect product contacting parts. Annex 1 now requires these parts to be sterilized before use. Some of these parts, such as stopper bowls, are very large or difficult to maneuver within the facility, making compliance with Annex 1 challenging. The validation of a steam sterilization cycle can become complicated depending on the makeup of the parts in the load. There are important requirements for this validation that will be discussed in this presentation. This includes removing indirect product contacting parts that could have been set in place on older filling lines. Best practices and case studies will be shared demonstrating best practices for wrapping challenging parts. Transferring these parts post sterilization is also challenging and the wrapping materials should be implemented to aid in the logistics of moving parts to the correct classified area. Once the sterilized parts are within the filling area, a VHP bio-decontamination cycle is completed for the isolator / RABs filling environment. This presentation will explain the best practice for the sequence of unwrapping, installation, bio-decontamination of the indirect product contacting parts.

    • Presenter:

      

      Renee V. Buthe
      Technical Services Manager, STERIS Corporation

  • 16:45 – 17:15

    Understanding the Dynamics of Particle and Microbial Transport in Isolators

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    Take a deep dive into computational fluid dynamics, airflow visualization and particle calculations to better understand the physical aspects of environmental monitoring (EM) data. Explore the efficiencies and limitations of different EM air sampling methods with a real-world case study in a Grade A isolator.

    • Presenter:

      

      Noel M. Long
      Senior Sterility Assurance Adviser, Cytiva

  • 17:15 – 17:45

    Q&A

EDT Daylight Time (UTC -4:00)

• 07:30 – 09:00

  Continental Breakfast

• 07:30 – 12:30

  Registration Open

• 07:45 – 09:00

  From Classroom to Cleanroom: Navigating a Career in Pharmaceutical Microbiology

  • Moderator:

    

    Frederic B. Ayers
    Senior Consultant - Microbiology, ValSource, Inc.

  Join us for a candid breakfast conversation where experienced professionals share insights, lessons learned, and the realities behind career growth. Guided by audience questions, this interactive session offers honest dialogue, practical advice, and fresh perspectives, no matter where you are in your professional journey

  • 07:45 – 08:05

    Panel Introductions
  • 08:05 – 09:00

    Panel Discussion and Q&A

    • Panelist:

      

      Ziva Abraham, PhD
      CEO, Microrite, Inc.

    • Panelist:

      

      Lori Daane, PhD
      Chief Scientific Officer, Bionique Testing Laboratories

    • Panelist:

      

      Irving Ford, MSc
      VP of Quality, Adaptimmune

    • Panelist:

      

      Marc Glogovsky, MS
      Business Unit Manager - Microbiology, ValSource, Inc.

• 09:15 – 10:30

  P4: Beyond Blame: A Systems Approach to Understanding and Preventing Human Error

  • Moderator:

    

    Frederic B. Ayers
    Senior Consultant - Microbiology, ValSource, Inc.

  Human error remains one of the most persistent and often misunderstood challenges in pharmaceutical manufacturing. This session will explore how a systems-based perspective can transform the way organizations understand, investigate, and mitigate human error. Dr. Patrice Tremoulet, a leading expert in human factors and cognitive systems engineering, will share practical strategies for identifying systemic contributors to error, designing resilient processes, and fostering a culture of continuous improvement. This session is essential for professionals committed to enhancing quality, safety, and compliance by addressing the true causes of human error.

  • 09:15 – 10:00

    A Systems Approach to Addressing Human Error

    • Presenter:

      

      Patrice D. Tremoulet, MS, PhD
      Director of Human Factors Engineering, ECRI

  • 10:00 – 10:30

    Q&A
• 10:30 – 11:00

  Networking Break

• 11:00 – 12:30

  P5: Ask the Experts

  • Moderator:

    

    Erika A. Pfeiler, PhD
    Senior Consultant - Microbiology, ValSource, Inc.

  • 11:00 – 11:10

    Panel Introduction
  • 11:10 – 12:25

    Panel Discussion and Q&A
  • 12:25 – 12:30

    Closing Remarks from the PDA Pharmaceutical Microbiology Conference 2026 Co-Chairs
• 14:00 – 18:30

  PDA Pyrogens Workshop 2025 (Day 1 of 2 - Separate Registration Required)

  This workshop is structured to ensure you are immersed in substance, enlightened by analysis of real-world case studies, and given the opportunity to work and engage with your fellow attendees alongside the experts. Register Today!

EDT Daylight Time (UTC -4:00)

• 08:00 – 16:45

  PDA Pyrogens Workshop 2025 (Day 2 of 2 - Separate Registration Required)

  This workshop is structured to ensure you are immersed in substance, enlightened by analysis of real-world case studies, and given the opportunity to work and engage with your fellow attendees alongside the experts. Register Today!
• 08:30 – 16:00

  PDA Training and Research Institute Training Courses (Separate Registration Required)

  In addition to the Microbiology Conference, PDA is offering a variety of training courses on Thursday, 30 October – giving attendees the opportunity to deepen their learning through practical, hands-on application.

  Register for PDA 618: Environmental Monitoring Methods & Investigations

  Register Today

  Register for PDA 542: Microbial Monitoring & Sterility Assurance

  Register Today

  • 08:30 – 16:00

    Developing a Microbial Monitoring Plan and Leveraging New Technologies for Effective Sterility Assurance in Aseptic Processes (PDA 542)

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    A strong microbial monitoring plan and a leveraging/introduction of new technologies should be used for all sterile medicinal products and sterile active substances. As required by the principles of Quality Risk Management, this ensures that microbial, particulate and pyrogen contamination associated with microbes is prevented in the final product. This training course provides tools, rationales and guidelines for designing a strong cleanroom microbial monitoring plan and for leveraging/introducing new technologies for effective sterility assurance in aseptic processes.

    • Instructor:

      

      Mark C. Hallworth
      Senior GMP Scientist, Particle Measuring Systems

    • Instructor:

      

      Ugonna Omeronye
      Global GMP Pharma Advisory Specialist, Particle Measuring Systems

  • 08:30 – 16:00

    Environmental Monitoring Methods and Investigations – Looking for the Needle in the Haystack (PDA 618)

    Read more

    Learn environmental monitoring techniques and how to investigate excursions. When alert and action levels are exceeded, appropriate investigations are required. Firms need to thoroughly investigate these excursions to find the root cause and implement corrective and preventative actions (CAPA). This training course will help the attendee learn the techniques of environmental monitoring, how to conduct a thorough investigation as well as corrective and preventative actions to help mitigate another excursion.