2021 PDA Pharmaceutical Microbiology Conference

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Welcome to the 2021 PDA Pharmaceutical Microbiology Conference!

This 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.

Take a look at the many opportunities that will shape the future of the pharmaceutical industry, such as how to best use non-compendial methods for microbial testing of new products, how to overcome challenges with aseptic processing, and what might be in store for the effective use of risk assessment and mitigation in product manufacturing, environmental monitoring, and microbial control. Additionally, the science of biotech microbiology and its impact on the industry in a dynamic fast paced global manufacturing environment will be addressed throughout the Conference.

The comprehensive program agenda will include presentations from global regulatory and industry experts who will share recent case studies and current trends in the field of pharmaceutical microbiology. The Conference will also highlight the following hot topics:

  • Novel biotechnology processes, including cell and gene therapies
  • Globalization of aseptic processing
  • Common microbial deficiencies in regulatory filings and inspections
  • Contamination control case studies
  • Innovative technologies, products, and processes
  • Learned lessons in a post COVID world-perspective from industry and regulators

There will be plenty of opportunities to listen to and directly interact with all the speakers, in addition to lively Q&A sessions that promise to stimulate the discussions and encourage attendee participation. Interactive breakfast sessions will feature small group discussions on topics important to the industry.

During the conference, PDA will host many poster presentations and an exhibition of leading bio/pharmaceutical companies that will showcase new technologies and trends for pharmaceutical microbiology strategies.

At the completion of this conference, participants will be able to:

  1. Broaden their knowledge in many areas of Microbiology by listening to the leaders in the industry in such topics as novel processes, products, and technologies
  2. Deepen their understanding of topics such as microbial risk, microbial control, and endotoxin testing
  3. Identify current and future trends in Microbiology
  4. Implement improvements at their own facilities using information gained through expert presentations and networking opportunities
  5. Identify regulatory and pharmacopeial expectations
  6. Understand global aspects of microbiology and aseptic processing
  7. Summarize best practices for utilizing EM data to control processes
  8. Apply some of the lessons learned by the pharmaceutical industry and regulators in a post COVID time
Program Highlights

2021 PDA Pharmaceutical Microbiology Conference is going full virtual!

Agenda

Discover What's Happening Each Day
Day 1 04 Oct Day 2 05 Oct Day 3 06 Oct
Monday, 4 October

Monday, 4 October

10:00 – 11:30 | P1: FDA’s Current Role in the COVID-19 Vaccines’ Development and Emergency use Approvals 
Moderator: Yeissa M. Chabrier-Rosello, PhD, Senior Pharmaceutical Quality Assessor, CDER, U.S. FDA

This session will discuss the U.S. FDA’s role in the clinical development of vaccines against SARS-CoV-2 Virus (which causes COVID-19 disease), in the context of Emergency Use Authorization and Licensure. An overview of the clinical trials and regulatory considerations, safety follow-ups and requirements will be discussed. This session will provide an in-depth discussion of the overall non-clinical and clinical considerations (focusing on safety and efficacy) and regulatory requirements for the development of COVID-19 vaccines from the Agency’s perspective.

10:00 | Welcome from Program Planning Committee Co-Chairs
Yeissa M. Chabrier-Rosello, PhD, Senior Pharmaceutical Quality Assessor, CDER, U.S. FDA
Mitch B. Garber, BS, RPh, Head of Quality Services, bluebird bio

10:15 | Considerations for the Development of Preventative COVID-19 Vaccines
Sudhakar Agnihothram, Biologist, CBER, U.S. FDA

11:00 | Q&A Panel
Rakesh Pandey, PhD, Chief, Regulatory Review Branch-2, CBER, U.S. FDA

11:45 – 12:15 | Exhibit Hall and Connect & Network

12:15 – 13:45 | Concurrent Sessions

A1: Rapid Microbiological Methods: Barriers and Success Stories 
Moderator: Simleen Kaur, MSc, Biologist, Team Lead, CBER, U.S. FDA

Rapid Microbiological Methods (RMM) continue to advance at all forefronts, including general research, food quality, and pharmaceutical applications. RMM gives output with increased precision and sensitivity in short timeframe when compared to traditional methods that may take days or even weeks to deliver outcomes. However, RMMs do have a set of barriers for fast development and widespread use at the same time. This session will share presentations addressing RMM implementation and regulatory acceptance issues, sharing success over validation difficulties and technical complexities, onboarding new products, and transferring methods for new developmental products.

12:15 | Back to the Future: Where are the Rapid Methods?
Michael J. Miller, PhD, President, Microbiology Consultants, LLC

12:40 | Implementing a Rapid Sterility Method: How we Went from Bold Idea to Completed Project at Lightspeed
Joanny Salvas, Senior Manager, Pfizer

13:00 | Rapid Methods – The Next Phase: A Framework for Multi-Product Adoption of Rapid Sterility Testing
Miriam Guest, Associate Principal Microbiologist, AstraZeneca

13:25 | Q&A Panel

B1: Contamination Control Strategies: Disinfectant Programs Support to Contamination Control
Moderator: Lydia Troutman, Director Sterile and Microbiology QA, Merck & Co., Inc.

Annex 1 requires designing an effective contamination control strategy (CCS) based on a scientific assessment to understand the process and to apply risk management principles. The strategy should consider all aspects of contamination control and its life cycle with ongoing and periodic review and update of the strategy as appropriate.

A sound cleaning and sanitization program is a key component of the contamination control strategy and must exist for classified and controlled environments used in the manufacture facility to prevent the microbial contamination. There are factors to be considered for the effectiveness of the sanitization program that may impact the ability of a disinfectant to perform adequately in a controlled environment. The cleaning and sanitization program must achieve specified cleanliness standards for microbial contamination control to within the facility.

12:15 | New Annex 1 Facility Assessment: Case study on the Steps Towards Compliance
Rafael Beaus, Global Consultancy Manager, Azbil Telstar

12:45 | Designing a Contamination Control Strategy in an Aseptic Cleanroom
James N. Polarine, Jr., MA, Senior Technical Service Manager, STERIS Corporation
Benoit Ramond, PhD, Head of Microbiology & Sterile Technology, Sanofi

13:05 | Q&A Panel

13:45 – 14:15 | Exhibit Hall, Poster Presentations, and Connect & Network

14:15 – 15:45 | Concurrent Sessions

A2: Developing and Managing an Effective Contamination Control Strategy
Moderator: Kim R. Sobien, Principal Sterility Assurance Engineer, PETNET Solutions | A Siemens Company

Many manufacturers have already developed multiple elements of a contamination control strategy (CCS), and still wrestle with tying them together in a single holistic program with a life-cycle approach. This session delves into best practices and case studies for defining, implementing, and sustaining successful contamination control strategies.

14:15 | Strengthening the 'c' for Contamination Control - An Approach for Continuous Improvement
Donald C. Singer, MA, Senior Microbiology Technical Consultant, North America, Ecolab Life Sciences

14:35 | Robust Contamination Control Strategies using Quality Risk Management and Quality System Oversight
Stephen E. Langille, PhD, Senior Microbiology Consultant, ValSource Inc.
Danica J. Brown, QRM Consultant, ValSource Inc.

15:00 | Implementation of Contamination Control Strategy Across the Facility in Novo Nordisk A/S
Jette Christensen, MSc, Scientific Director, Novo Nordisk A/S

15:25 | Q&A Panel

B2: Rising to the Challenge of Rapid Microbial Methods and Innovation: Industry Applications
Moderator: Kurt Jaecques, MA, Global Aseptic Technologies Lead Monitoring & Control, GlaxoSmithKline Vaccines

Several rapid methods do not require microbial growth prior to detection or enumeration and, as such, the time to result can be close to real-time. Rapid methods that achieve these results include flow and solid-phase cytometry and biofluorescence detection of microorganisms in air. Although RMM is becoming more and more convenient, performant and accepted by regulatory bodies, some hesitation still exists to replace standard methods. Within this session, two case studies and one practical application will be presented that might help the industry to rise to this challenge.

14:15 | Case Study using Alternative Rapid Microbial Method Scan RDI to Release Broad Spectrum Antivirals
Omkar Baburao Patil, MSc Microbiology, Associate Director-Microbiology, Cipla Limited, Goa 

14:45 | Implementation of Biofluorescence Particle Counters to Replace Traditional EM Methods
Thais Vilgren, MSc, Principal Scientist, Global Lead Aseptic Processing, Novo Nordisk

15:05 | Case Study: Expediting Mold Investigations with Biofluorescent Particle Counting Technology
Dawn M. Watson, Director, Microbial Control, Merck & Co., Inc.

15:25 | Q&A Panel

15:45– 16:15 | Connect & Network

Tuesday, 5 October

Tuesday, 5 October

08:30 – 09:45 | Morning Session 1: Understanding Regulatory Expectations and Strategies to Achieve them for Pharmacy Compounding and Virtual Facility Inspections
Moderator: Lynne A. Ensor, PhD, Vice President, RCS Head of Global Compliance, PAREXEL International

This session will focus on providing useful information related to understanding and addressing regulatory expectations for CMC and/or cGMP for pharmacy compounding and virtual facility inspections. Obstacles encountered during pharmacy compounding related to testing for potential microbial contamination will be covered. Additionally, the challenges presented by COVID-19 pandemic’s impact on the regulatory facility inspection process and the pivot to supporting virtual inspections will be discussed. Recommendations towards achieving regulatory expectations and tips to ensure they are demonstrated to regulators will be shared.

08:30 | Overcoming the Gap Between 503A and 503B Microbiology-Related Testing
Abby A. Roth, CMQ/OE, Senior Director of Business Operations, CriticalPoint, LLC.

09:00 | Virtual Inspections: Paradigm Shift in Inspector/Site Interactions
Marcia C. Baroni, MBA, VP Quality Operations, Emergent BioSolutions

09:20 | Q&A Panel

10:00 – 11:30 | P2: Clean is Not Sterile: A Planetary Science and Planetary Protection Perspective on Cleanroom Microbiology at NASA
Moderator: MaryEllen E. Usarzewicz, MS, Associate Scientific Director, ASO Microbiology, Bristol-Myers Squibb

Prevention of microbial contamination as well as cleanroom design pose great challenges for the curation of extraterrestrial samples from NASA’s past and future sample return missions. Microbial monitoring data from existing NASA cleanrooms will be reviewed. Lessons learned from those data, as well as from the pharmaceutical industry and academia regarding design of new laboratories and equipment that will protect both Astro materials and earth from unwanted microbial contamination will be presented. In addition, a Planetary Protection Project will be discussed as it pertains to sampling of the external microbiome of the International Space Station and how results from this research will be used to design facilities for use on Mars in order to limit the amount of contamination associated with crewed missions.

10:00 | Aaron B. Regberg, PhD, Geomicrobiologist, Planetary Protection Lead, Astromaterials Research and Exploration Science Division, NASA

11:00 | Q&A Panel

11:30 – 12:00 | Exhibit Hall and Connect & Network

12:00 – 13:30 | Concurrent Sessions

A3: Contamination Control Strategies: Risk Assessments for Sterile and Non-Sterile Products
Moderator: Vineeta A. Pradhan, PhD, Microbiologist, CVM, U.S. FDA

Contamination control is a challenging and significant issue for the pharmaceutical industry. Steps to identify, assess, and evaluate controls that will minimize risk of the sources of microbial and particulate contamination are necessary. The importance of quality risk management approaches has been recognized in the pharmaceutical industry and has become a valuable component supporting contamination control. In the first presentation, the speaker will discuss important factors, key deficiencies, and knowledge gaps that need attention in products using real-life case studies. Both common contamination causes as well as specific causes of recurrent microbial contamination events across all products will be discussed. In the second presentation, the speaker will provide an overview of the regulations, standards, and guidance documents defining objectionable organisms in various product types. The second presentation will focus on a risk-based method for evaluating the hazards posed by microorganisms in non-sterile manufacturing processes, intermediates, and finished products.

12:00 | Contamination Case Studies for Sterile, Non-Sterile, Cell and Gene Therapy Products
Ziva Abraham, PhD, CEO, Microrite, Inc.

12:30 | What’s Objectionable? Evaluating the Impact of Various Microorganisms in Non-Sterile Manufacturing
Tiffany A. Baker, MBA, Consultant, ValSource Inc.

13:00 | Q&A

B3: Pyrogen Testing: Automation Case Studies and Improved Safety Testing
Moderator: Friedrich von Wintzingerode, PhD, QC Lead iNeST (individual Neoepitope Specific Therapy),Genentech Inc

Automated endotoxin testing and the monocyte activation test (MAT) are hot topics in the field of pyrogen testing. Two industry case studies demonstrate the benefits of automated LAL and rFC testing for QC laboratories. A third presentation underlines the potentiated risk to patient safety associated with the contamination of mixed pyrogens which at present largely go undetected, and MAT’s standing as the solution.

12:00 | Holy Crab! A Simple, Automated Sample-to-Answer Recombinant Factor C Assay for Bacterial Endotoxins
Jay S. Bolden, Associate Quality Advisor-Biologist, Eli Lilly
Cindy M. Heath, Senior Research Scientist – Automation, Eli Lilly

12:25 | MAT: Understanding and Mitigating Patient Safety Risks due to Synergistic Effects of Mixed Pyrogens
Shabnam Solati, MS, CEO, CTL-MAT

12:45 | Implementing the QC Lab of the Future Today: Automating Endotoxin Testing for Water and Buffer Samples
Aude J. Smeets, PhD, Analytical Technical Expert (Automation Field), GSK

13:05 | Q&A Panel

13:30 – 14:00 | Exhibit Hall, Poster Presentations, and Connect & Network

14:00 – 15:30 | Concurrent Sessions

A4: Surfaces, Water, and Air, Oh My! Tackling Different Contamination Risks
Moderator: Jason L. Willett, Midwest Manager, Veltek Associates, Inc.

While contamination can seem like a scary topic, this session will help ease those fears as we explore three distinct areas of contamination risk and provide valuable knowledge to tackle contamination in your own facilities. The first presentation will discuss the real-world factors that negatively impact disinfectant performance and how to avoid them to ensure an effective disinfection program. The second presentation will share case studies of rapid microbial methods (RMM) where the challenge of early detection and response to microbiological contamination of pharmaceutical water were solved. Lastly, the third presentation will present case studies that detail several contamination challenges related to flawed cleanroom and barrier system design or integration as well as how qualification testing did not detect these problems.

14:00 | Variables Affecting Disinfectant Performance
Dan A. Klein, MA, Senior Technical Service Manager, STERIS Corporation

14:20 | Microbiological Quality Control for Pharmaceutical Water by Rapid Microbiological Methods
Yoko Nakai, Manager, HORIBA Advanced Techno, Co., Ltd.

14:50 | Sources of Contamination Due to Flawed Barrier System Design, Cleanroom Layout or Integration
Morgan Polen, Cleanroom, Air Flow and Particle Contamination Expert, Microrite, Inc.

15:10 | Q&A Panel

B4: Risky Business: Real World Risk-Based Approaches for Personnel Monitoring and EM Incubation
Moderator: Christine Sherman, BA, Sterilization & Aseptic Processing Global Microbiology Management, Takeda

A large part of a microbiologist’s daily responsibilities is managing risk. Without the appropriate information, it is not possible to make good judgements about testing programs and product decisions. Kenneth Boones’s presentation will provide excellent insight in the bioburden levels and effective methods to recover Cutibacterium acnes in aseptic processing areas. This is an example of what you don’t know can really impact your sterility assurance program. Thierry Bonnevay and Laurent Leblanc will discuss a single incubation temperature scheme for environmental samples which was completed in collaboration between bioMérieux and Sanofi Pasteur. This has been an ongoing topic at previous PDA Microbiology Conferences and will hopefully influence your risk assessment of following this incubation model.

14:00 | Environmental and Personnel Monitoring Programs—A Risk-Based Case Study of Cutibacterium Acnes
Kenneth W. Boone, Director, Sterile & Microbiology Quality Assurance, Global Compliance, Merck & Co., Inc.

14:30 | Suitability of a Single Incubation Temperature for Environmental Monitoring Program 
Laurent Leblanc, Microbiological R&D Manager, bioMérieux 
Thierry Bonnevay, Microbiology Analytical Expert, Sanofi Pasteur 

15:00 | Q&A Panel

15:30 – 16:00 | Connect & Network

Wednesday, 6 October

Wednesday, 6 October

08:30 – 09:45 | Morning Session 2: The Criticality of Aseptic Training on Product Quality and Patient Risk
Moderator: Lynne A. Ensor, PhD, Vice President, RCS Head of Global Compliance, PAREXEL International

To ensure critical quality attributes are achieved for aseptically manufactured products, it is essential sterile entry personnel are trained so they have the appropriate level of aseptic-related knowledge to support the successful manufacture of sterile products. This session will explore aseptic training content and approaches to be considered for training sterile entry personnel responsible for manufacturing sterile products. Additionally, a case study will be presented regarding training of staff performing aseptic technique to assess the effectiveness of personnel training and the maintenance of aseptic manufacturing conditions.

08:30 | Aseptic Training of Sterile Entry Personnel is Imperative to Ensure Sterility of Injectable Products
Susan L. Ashley, PhD, Associate Director, Merck & Co., Inc.

09:00 | A Case Study: Effective Training Strategies for Personnel Executing Aseptic Activities
Shelley M. Preslar, MBA, President & COO, Azzur Training Center Raleigh LLC

09:20 | Q&A Panel

10:00 – 11:30 | P3: PDA Gets Personal – A Macro Look at Micro Careers
Moderator: Mitch B. Garber, BS, RPh, Head of Quality Services, bluebird bio

We all had to start somewhere to get to where we are in our career. Some may have taken the path directly from College to Industry, while others bounced back and forth between Industry and Regulatory. This session will explore the differences and similarities between those just starting off in their career with those who are more experienced. Come and engage in this exciting and fun dialogue with our panelists as we discuss career changes, technology hurdles, PDA’s influence in their careers, and so much more!

10:00 | Panel Discussion
Lynne A. Ensor, PhD, Vice President, RCS Head of Global Compliance, PAREXEL International
Amy L. McDaniel, PhD, Director, Microbial Center of Excellence & Operations, Bristol-Myers Squibb
John W. Metcalfe, PhD, Master Microbiology Reviewer, CDER, U.S. FDA
Dan J. Bice, Associate Director Quality Control Operations, Adaptimmune
Seth T. Schulte, MS, Biologist, CBER, U.S. FDA
Kristin N. Valente, PhD, Director, Vaccine Technical Operations, Merck & Co., Inc.


11:30 – 12:00 | Exhibit Hall and Connect & Network

12:00 – 13:30 | Concurrent Sessions

A5: Advances in Environmental Monitoring Technology and Practices
Moderator: Josh Eaton, Assistant Director, Scientific Affairs, PDA

The adoption of Pharma 4.0 concepts and practices presents a need for faster yet still accurate methods for contamination detection. This session will present proof of concept on using BacT/ALERT technology for rapid and sensitive detection of fungal contaminants and a case study on leveraging digital transformation to provide real-time responses to contamination risks, including predictive modeling.

12:00 | iLYM Media Improves Fungal Detection on the BacT/ALERT for ATMP Sterility Testing
Anna F. Lau, PhD, D(ABMM), Chief, Sterility Testing Service, National Institutes of Health

12:30 | Using Machine Learning and Artificial Intelligence to Predict Microbial Risk in Cleanroom Environments
Tamara Garcia-armisen, PhD, Sterility Assurance Manager, GSK Vaccines-Living Viral Vaccines Manufacturing
Sander W. Timmer, PhD, Global Director of Analytics & AI, GSK Vaccines

13:00 | Q&A Panel

B5: Contamination Control Strategy: Fundamental Aspects and New Technologies
Moderator: Friedrich von Wintzingerode, PhD, QC Lead iNeST (individual Neoepitope Specific Therapy), Genentech Inc

With the upcoming revision of Annex 1, defining a robust contamination control strategy is becoming increasingly important. This session will provide additional considerations around a holistic approach to CCS, such as integrated trending, and the opportunity to reevaluate CCS when novel technologies offer a different risk profile.

12:00 | Shifting Strategies for Contamination Control – Novel Approaches for Novel Technologies
Joseph E. McCall, SM (NRCM), Director, QA Technical Services, ADMA Biologics
Hoang N. Phan, Distinguished Engineer, Network Technology Lead, Genentech

12:25 | Essentials for a Sound Total Contamination Control Trending Program
Sheba Zaman, BS, Head of Product Specialists and Training Services, Novatek

12:55 | Q&A Panel

13:30 – 14:00 | Exhibit Hall, Poster Presentations, and Connect & Network

14:00 – 15:45 | P4: Ask the Regulators
Moderator: John W. Metcalfe, PhD, Master Microbiology Reviewer, CDER, U.S. FDA and Yeissa M. Chabrier-Rosello, PhD, Senior Pharmaceutical Quality Assessor, CDER, U.S. FDA

During this interactive session, U.S. FDA 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 from reviewers of compounding, sterility assurance, aseptic processing, and terminal sterilization of small molecules. In addition, biotechnology professionals can seek input from agency experts on biosimilars and new molecules manufactured using biotechnology processes. Finally, expert field inspectors 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!

14:00 | Panel Discussion
Renée Blosser, MS, Master Microbiology Reviewer, CVM, U.S. FDA
Candace Y. Gomez-Broughton, Supervisory Microbiologist, CDER, U.S. FDA
Brooke K. Higgins, MS, Senior Policy Advisor, CDER, U.S. FDA
Marla K. Stevens-Riley, Supervisory Microbiologist, CDER, U.S. FDA

15:30 | Closing Remarks from 2022 PDA Global Conference on Pharmaceutical Microbiology Co-Chairs

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