2023 PDA Pharmaceutical Microbiology Conference
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The 2023 PDA Pharmaceutical Microbiology Conference continues the ongoing tradition of addressing the opportunities and challenges, most relevant, to the future of microbiology in today's global market. Join new and seasoned professionals from all facets of the field, including global industry, academia, and regulatory authorities, to share insights on how to best prepare for the future through the sharing of best practices, development of standards, and integration of innovative technologies.
PROGRAM PLANNING COMMITTEE
- Kurt Jaecques, GSK (Co-Chair)
- Vineeta Pradhan, U.S. FDA (Co-Chair)
- Frederic Ayers, ValSource, Inc.
- Daniel Bice, Teva
- Yeissa Chabrier-Rosello, U.S. FDA
- Lori Daane, bioMérieux, Inc.
- Lynne Ensor, Parexel
- Mitch Garber, 2seventy bio
- Marc Glogovsky, ValSource, Inc.
- Simleen Kaur, U.S. FDA
- Heike Merget-Millitzer, J&J
- Dawn Watson, Merck & Co., Inc.
- Jason Willett, Veltek Associates
Program Highlights
The conference will be followed by the interactive 2023 PDA Microbial Data Deviation Investigations Workshop!
Agenda
Discover What's Happening Each Day
SUNDAY, 01 OCTOBER
14:00 – 19:00 | Registration Open
MONDAY, 02 OCTOBER
07:30 – 17:30 | Registration Open
07:30 – 08:30 | Continental Breakfast
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08:30 – 10:00 | P1: Patient Perspective Rob Weker worked his entire career in healthcare and is a three-time cancer survivor. In this patient perspective opening plenary, he will share his pancreatic cancer journey, from diagnosis through treatment. Rob will detail how he and his family made many difficult treatment decisions while having continuous challenges from his medical insurance company. He will also describe his thought process and decision to go against the wishes of his family, and the advice of several doctors, to enter a clinical trial study, which he believes ultimately saved his life. Everyone has been touched somehow by cancer, either directly or indirectly, which drives Rob’s passion to share his learnings and journey with everyone he can. His hope is to influence and motivate the scientists and regulatory professionals at this PDA event with his message. |
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08:30 | Opening Remarks from Conference Co-Chairs 08:40 | A Cancer Journey as Seen Through the Patient Lens |
10:00 – 10:45 | Networking Break
10:45 – 12:15 | Concurrent Sessions
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A1: Isolators and Critical Zones: Optimal Strategies for Decontamination and Sterilization While the use of isolators significantly reduces the risk of contamination, conventional aseptic processing areas are still widely used today. It is imperative to maintain strict control of these environments, which is in part accomplished through a robust cleaning and disinfection program that utilizes sterilized or pre-sterile disinfection agents. This session will describe the essential elements of sterility validation for irradiated disinfection supplies and agents and how to reduce the risk of contamination while considering their chemical stability once opened. For such an impactful technology with decades of history, implementation of isolators has been regrettably slow. One of the major obstacles to isolator technology is validation of the vapor phase hydrogen peroxide (VPHP) decontamination cycle. This session will provide insights into recommended best practices for VPHP cycle development from an industry collaboration, an introduction to enzyme indicators, and strategies to optimize cycle validation for robust, effective, and more efficient decontamination cycles. |
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10:45 | Sterility, Sterilants, and Sterilization 11:15 | BioPhorum Isolator Good Operating Practices Team: Industry Guidance for Vapor Phase Hydrogen Peroxide Cycle Development |
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B1: Elements of Effective and Robust Microbiology Laboratory Investigations Inadequate performance and documentation of investigations represent a large proportion of observations from health authorities. In this session, the presenters will discuss best practices and examples for conducting effective and robust microbiology laboratory investigations in support of a thorough root cause analysis. Elements to consider for bioburden investigations in non-sterile manufacturing as well as for environmental monitoring (EM) limit excursions will be addressed. The importance of identifying the type of contaminant to determine the root cause and to define respective remediation measures will also be highlighted. |
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10:45 | Bioburden Investigations in Non-sterile Biologics Processing 11:05 | Get Out from Behind Your Computer to Conduct Comprehensive EM Investigations 11:35 | Investigating Cleanroom Contamination and Disinfection Strategies |
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C1: Endotoxins and Pyrogens: Next Generation Testing Platforms |
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10:45 | Characterization of Endotoxin-Detecting rFC Products for Evaluation of Manufacturing Quality and Assay Performance 11:05 | Suitability of rFC-Based Endotoxin Tests: A Comparison Study Including Different Pharmaceutically-Relevant Grades of Water 11:25 | MAT: A Case Study from Method Development and Validation to Release Testing of Drug Products |
12:15 – 13:45 | Grand Opening of the Exhibit Hall, Networking Lunch, Exhibitor Tech Talks, and Poster Presentations
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Exhibitor Tech Talks 12:25 – 12:35 | BIOFIRE® MYCOPLASMA: Testing by Anyone, Anywhere, Anytime 12:40 – 12:50 | Want to Standardize the Results of the BET Assay? Here is How! 12:55 – 13:05 | The Wait is Over: Introducing Endosafe Trillium rCR 13:10 – 13:20 | Sievers Soleil: Bioburden Results in Under an Hour |
13:45 – 15:15 | Concurrent Sessions
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A2: Reflecting on "Microbiology Testing of the Future" Reflecting on "microbiology testing of the future", our first thoughts guide us towards implementation of rapid microbial methods (RMM) to allow fast release of microbial quality control (QC) testing results. Whilst this should indeed be one of the main goals, it is not the only one. Of equal importance is the immediate access to data in the right format. Finally, within this lab of the future, we will need competent microbiologists with the ability to follow this evolution and make the right decisions quickly and effectively. In this session, the presenters will cover these three aspects by looking at an RMM for mycoplasma, how we can efficiently access and trend our data, and finally how we can build and ensure the right competencies for our microbiology experts of the future. |
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13:45 | Implementation of a Novel Mycoplasma Testing Technology to Increase Automation and Real-Time-Release 14:05 | A Novel Method to Extract Environmental Monitoring (EM) Data from Paper Records for Use in Monitoring and Trending 14:30 | Pharmaceutical Microbiologists: Training for Competency in the Next Decade and Beyond |
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B2: Aseptic Manufacturing: Sterile Compounding to BLAs/Biosimilars and Some Regulatory Considerations |
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13:45 | Sterile Compounding: Clarity from Chaos 14:05 | Sterile Filtration of Biological Products 14:25 | FDA Oversight of Compounded Drugs |
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C2: Endotoxin Masking: Contributing Factors and Mitigation Strategies Low recovery or masking of endotoxins has been reported in a variety of publications and assessment of the potential for low endotoxin recovery (LER) is a requirement within BLAs for specified biologics. This session will provide an overview of the LER phenomenon based on numerous case studies, an in-depth look at possible contributing factors, including container effects and processing steps, and considerations and approaches to mitigate the occurrence of LER and facilitate endotoxin removal throughout the manufacturing process. |
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13:45 | Overcoming Low Endotoxin Recovery: From Theory to Practice 14:10 | The Impact of Endotoxin Masking on the Removal of Endotoxin during Manufacturing of a Biopharmaceutical Drug Product 14:30 | Endotoxin Masking: Dependency on Container Type and Material |
15:15 – 16:00 | Networking Break (sponsored by Charles River), Exhibitor Tech Talks, and Poster Presentations in the Exhibit Hall
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Exhibitor Tech Talks 15:25 – 15:35 | Detecting Contaminants, Ensuring Purity: A Closer Look at Our New High-Performance Mycoplasma Testing Solution |
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16:00 – 17:00 | P2: Connecting the Dots Between Spillover and Disease Emergence Dr. David Kennedy is an Assistant Professor of Biology studying pathogen ecology at The Pennsylvania State University. In this session, he will discuss pathogen spillover and the challenges associated with experimentally studying spillover in the lab. According to Dr Kennedy, pathogens spillover into humans frequently but understanding “the likelihood that a virus will be transmissible in a new host is hugely challenging, especially with the replication needed to gain scientific insight.” Dr. Kennedy will also present his research model of using nematodes as a unique host organism and how this model has promise to predict future crossovers before they develop into global pandemics. |
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16:00 | "Crawling" Towards a Predictive Framework for Host Jumps and Pandemics |
17:00 – 18:00 | Networking Reception in the Exhibit Hall (Sponsored by Veolia WTS - Sievers Instruments)
TUESDAY, 03 OCTOBER
07:30 – 18:00 | Registration Open
07:30 – 09:00 | Continental Breakfast
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07:45 – 08:45 | Microbiology/Environmental Monitoring Interest Group |
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09:00 – 10:00 | P3: The Journey of Quality Intelligence: A Roadmap to Compliance in the 21st Century |
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09:00 | Critical Thinking in a Regulated Environment |
10:00 – 10:45 | Networking Break and Poster Presentations in the Exhibit Hall
10:45 – 12:15 | Concurrent Sessions
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A3: Monitoring Efficiencies and Contamination Control Strategies This session will encompass a quality risk management (QRM) tool to establish risk-based bioburden programs based on guidance principles in ICHQ11 and USP <1115> and their application to the facility and bioburden program. Additionally, how to create a robust global contamination control strategy and effectively implementing the aligned vision and the challenges with it to each site will be discussed. |
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10:45 | Establishing a Risk-Based Bioburden Control Program in a Low Bioburden API Production 11:10 | Starting with the End in Mind: How to Implement a Multi-Site CDMO Contamination Control Strategy |
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B3: Challenges and Opportunities for Aseptic Processing for Multiple Modalities including ATMPs Cleanrooms are engineered areas designed to minimize proliferation of microorganisms and to maintain low concentration of airborne particles. These are essential for industrial production, and are also designed to control other environmental parameters, such as temperature, humidity, and pressure. In this session, there will be two different journeys discussed along with a review of current regulatory inspection and enforcement trends for aseptic processing. |
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10:45 | The Journey to Build a Clinical Cell and Gene Therapy Facility Stephen E. Langille, PhD, Senior Microbiology Consultant, ValSource, Inc. 11:40 | Q&A |
12:15 – 13:45 | Networking Lunch and Poster Presentations in the Exhibit Hall
13:45 – 15:15 | Concurrent Sessions
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A4: ATMPs: Translating Bench Development to a Controlled Manufacturing Process Advanced therapeutic medicinal products (ATMPs), “next generation” pharmaceuticals, offer novel technologies for new options for disease treatments based on cells, gene therapy, or tissue replacement. However, due to the diversity of product types and unique manufacturing processes, maintaining aseptic practices and monitoring quality of ATMPs have been a challenge. This session will focus on different approaches for developing microbial control strategies and establishing good aseptic practices for successful production of ATMPs under good manufacturing process. |
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13:45 | Establishing a Microbial Contamination Testing Strategy for Live Biotherapeutic Products: Regulatory Requirements, Practical Experience, and Future Development Opportunities 14:05 | The Power of High-Resolution Risk Data: Holistic ATMP Contamination Control Strategy 14:30 | The Myth of the "Non-GMP" Space: The Criticality of Establishing Good Aseptic Practices in the Development Environment |
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B4: Contamination Control in Annex 1: Two Case Studies The Annex 1 revision clarified expectations on multiple aspects of contamination control while also stirring debate on the correct implementation. The use of quality risk management (QRM) principles and, more specifically, the requirement to generate a documented contamination control strategy (CCS) triggered many questions. How should one structure this document and how it can help drive continuous improvement of your processes? The revision also reignited discussions on the rotation of disinfectants. In this session, the presenters will discuss a case study on the use of risk assessment and will evaluate surface environmental monitoring (EM) data from different pharmaceutical organizations to evaluate a possible suitable disinfectant rotation strategy. |
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13:45 | Case Study on the Implementation of Annex 1 Risk Assessment Requirements 14:15 | Collaborating to Innovate Effective Disinfectant Rotation for Contamination Control |
15:15 – 16:00 | Networking Break and Poster Presentations in the Exhibit Hall
16:00 – 17:45 | Concurrent Sessions
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A5: Avoiding the "Spray and Pray" Approach to Environmental Monitoring Cleanroom environments supporting the manufacture of drug substances and drug products require strict control to minimize the potential for microbiological and particulate contamination of the product. Therefore, it is important to have a robust process for the establishment of an environmental monitoring (EM) program and its qualification. This session will walk through the process of establishing and implementing the baseline EM program starting from the EM performance qualification (EMPQ), continuing through to selection of sample locations and frequencies, and concluding with implementation of the routine monitoring program. Presentations will focus on a risk-based approach following quality risk management (QRM) principles, expanding the “living” program to other sites within a firm’s organization as well as optimization of site selection. |
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16:00 | What Really is Risk-Based EM? 16:25 | Case Study: Application of Industry Harmonized Approach to EM Performance Qualification 16:50 | Case Studies on Implementing a Global Risk-Based EM Approach Across a Range of Production Facilities |
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B5: On Your Mark, Get Set, Disinfect! Disinfection can seem like a never-ending race against microorganisms, but with proper planning and preparation, facilities can take the checkered flag. During this session, the presenters will dive into the fundamentals of disinfectant efficacy testing with an emphasis on method development, establishing acceptance criteria and performing the method. A new, non-UV antimicrobial light technology that allows for lights-on, around-the-clock disinfection with a case study showcasing environmental monitoring data before and after installation of the antimicrobial lights will also be explored. The final presentation will examine ways to mitigate the subjectivity surrounding disinfectant qualification with the goal of developing a successful, scientific based cleaning and disinfection program. |
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16:00 | Fundamentals of Disinfectant Efficacy Testing 16:25 | Case Study: Effectiveness of Non-UV Anti-Microbial Light in Pharmaceutical Manufacturing Clean Room Gowning Area and Further Applications 16:45 | Disinfectant Qualification: A Subjective Test |
WEDNESDAY, 04 OCTOBER
07:15 – 12:45 | Registration Open
07:15 – 08:45 | Continental Breakfast
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07:30 – 08:15 | Breakfast Session: USP Microbiological Standards Practical and relevant standards firmly based in current scientific knowledge are critical to the continued assurance of the supply of quality drugs and devices. The United States Pharmacopeia (USP) is focused on providing such standards in its continuing work in key areas of importance including: endotoxins and pyrogens, rapid (modern) microbiological methods, bioburden contamination testing, microbial control, and sterility assurance. This session will provide an update on the current work plan of the USP General Chapters Microbiology Expert Committee and its related subcommittees. Included in this session will be an outline of the current priorities and future plans for the development of related standards, best practices for sterility assurance and microbial control, and stakeholder engagement opportunities. Additionally, a brief refresher regarding the USP standard setting process, including opportunities for stakeholder engagement identified, will be discussed. |
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07:30 | An Overview and Update on Future Plans |
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08:30 – 10:00 | P4: Fraud and Deception in Science Science builds upon science. How we design experiments and gain knowledge to improve patient health and safety depends on peer-reviewed publications. But can we believe everything we see? Papers that contain incorrect, or even falsified, data and manipulated images lead to wasted time and money spent by other researchers trying to reproduce those results. This in turn causes delays in the development of successful drugs and treatments. Several high-profile science misconduct cases have been reported, but many more cases remain undetected. Meet Elisabeth Bik, an image forensics detective who left her paid job in industry to search and report biomedical articles that contain errors or data of concern. She has done a systematic scan of 20,000 papers in 40 journals and found that about 4% of these papers contained inappropriately duplicated images. In her presentation, she will describe her work and show several types of inappropriately duplicated images and other examples of research misconduct. In addition, she will share how to report scientific papers of concern, and how journals and institutions handle such allegations. |
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08:30 | Image Duplication, Manipulation, and Other Types of Problems in Biomedical Research |
10:00 – 10:30 | Networking Break
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10:30 – 12:15 | P5: Ask the Regulators Panel Discussion During this interactive session, U.S. FDA representatives will provide insight into questions posed by audience participants. The session is targeted to participants from all segments of the pharmaceutical industry for human and animal drugs and will provide valuable perspectives from agency experts who assess microbiological quality of non-sterile and sterile drugs and biologics. The panel members have extensive experience in several areas pertaining to product sterility assurance, including terminal sterilization, aseptic processing, and compounding. In addition, expert field investigators will provide their perspectives on inspection-related questions. Don't miss this unique opportunity to interact with regulators in an open forum focused exclusively on your microbiology concerns! |
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10:30 | Panel Discussion |
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