2022 PDA Pharmaceutical Microbiology Conference (2022)

2022 PDA Pharmaceutical Microbiology Conference (1)

Oct 10 - Oct 12, 2022

Washington, DC

Leading through Science: A Monumental Undertaking

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The program agenda is now available!


Welcome to the 2022 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.


  • Day 1

  • Day 2

  • Day 3


    07:00 – 17:30 |Registration Open

    07:00 – 08:30 | Continental Breakfast

    08:15 – 10:00 | P1: Antibiotics: A Double-Edged Sword!
    Moderator: Vineeta A. Pradhan, PhD, Microbiologist, CVM, U.S. FDA

    Dr. Martin Blaser, the Director of the Center for Advanced Biotechnology and Medicine at Rutgers Biomedical and Health Sciences, will take us on a deep dive into the human microbiome. This plenary session will focus on how the equilibrium of the internal ecosystem between bacterial and human cells has been severely disrupted due to an overreliance on medical advances such as antibiotics and surgical procedures. The speaker will highlight some groundbreaking scientific evidence and build a compelling case on the unintended impact of antibiotic usage. Dr. Blaser will discuss additional insights from his best-selling book, “Missing Microbes: How the Overuse Of Antibiotics Is Fueling Our Modern Plague”. Join us for an exciting session to kick off the conference!

    08:15 | Welcome from PDA President
    Richard Johnson, President, PDA

    (Video) PDA Letter On The Issue: 10th PDA Virus Conference

    08:30 | Welcome from Program Planning Committee Co-Chair
    Mitch B. Garber, BS, RPh, Head of Quality Services & Compliance, 2seventy bio

    08:45 | The Two-Edged Sword of Antibiotics
    Martin Blaser, MD, Director, Center for Advanced Biotechnology and Medicine/RWJMS/Rutgers University

    09:30 | Q&A

    10:00 – 10:45 |Refreshment Break

    10:45 – 12:15 | Concurrent Sessions

    A1: Redefining Environmental Monitoring
    Moderator: Dan Bice, Associate Director Quality Control Operations, Adaptimmune

    During this session, the intent is to provide detailed insight into the major changes and new guidance provided within Technical Report #13 as well as the upcoming Annex 1. Additionally, methods of interpreting environmental monitoring data and using it to create limits, trend data, show the importance of recovery rates and their uses, as well as ensuring you are within regulatory limits.

    10:45 | Ways to Evaluate Environmental Monitoring Data as part of a Robust Contamination Control Strategy
    Frederic B. Ayers, Advisor – Global Quality Systems, Eli Lilly and Company

    11:05 |Changes in the new revision to PDA Technical Report #13, Fundamentals of an Environmental Monitoring Program
    Kurt Jaecques, MA, Global Aseptic Technologies Lead Monitoring & Control, GSK Vaccines
    Marc Glogovsky, MS, SM (NRCM),Business Unit Manager/Senior Consultant – Microbiology, Valsource, Inc.

    11:25 | Q&A

    B1: Do You Manage Contamination or Does It Manage You?
    Moderator: MaryEllen E. Usarzewicz, MS, Director, QC Microbiology, Bristol-Myers Squibb

    Every day we deal with many aspects of contamination, whether we are defining control strategies or solving related critical issues. How we deal with contamination impacts many facets of our business. During this session, points will be considered around the management of contaminated resins, an innovative case study will be presented on performing media fill inspection in just a few hours as well as strategies around upholding container closure.

    10:45 | Remediation of Contaminated Protein A resin: Guidance for Operational Teams
    Angelica Welch, BS, MSAT Consultant, ValSource

    11:10 | What if you Could do your Media Fill Inspection in a Couple of Hours? A Case Study for the Application of Inspection Technology to Micro Testing
    Joanny Salvas, Senior Manager, Pfizer

    11:30 | Systematically Safeguarding Container Closure System for Controlling Microbial Contamination
    Oliver P. Stauffer, MBA, CEO, Packaging Technologies & Inspection LLC

    11:55 | Q&A

    12:15 – 13:45|Grand Opening of the Exhibit Hall, Networking Lunch, and Poster Presentations

    13:45 – 15:15 | Concurrent Sessions

    A2:Cleanroom Classics
    Moderator: Mitch B. Garber, BS, RPh, Head of Quality Services & Compliance, 2seventy bio

    There must be contamination control strategy documentation to support the qualification of clean rooms. The presentations included in this session will explore the differences in clean room qualifications versus monitoring along with a case study on common mistakes and misunderstandings in non-viable particle counting. In addition, there will be a session on the evaluation of a ready to use disinfection regimen to support a contamination control strategy.

    13:45| The Five Micron Particle Dilemma, Common Mistakes and Misunderstandings in Non-Viable Particle Counting (Cleanroom Classification and Monitoring)
    Morgan Polen, Cleanroom, Air Flow and Particle Contamination Expert, Microrite, inc.

    14:10 | The Evaluation of a Ready to Use Combination Disinfection Regimen to Support a Contamination Control Strategy
    Thomas M. Walker, BS, TRD QA Site Lead, Novartis Pharmaceuticals

    14:30 | Cleanroom Qualification vs. Monitoring: Differences in Regulatory Expectations
    Gilberto Dalmaso, PhD, Technical Science Director for Europe and Asia, Veltek Associates Inc.

    14:55 | Q&A

    B2: Making it Happen: Applications of Rapid Microbiological Methods
    Moderator: Kurt Jaecques, MA, Global Aseptic Technologies Lead Monitoring & Control, GSK Vaccines

    Rapid microbiological methods (RMM) are becoming more and more convenient, performant and accepted, or even recommended, by regulatory bodies (referred now in new EU Annex 1). From a Quality Risk Management and contamination control strategy perspective, implementation of RMM can really help gaining process insight, faster root cause detection, prevent risks, and increase productivity. During this session we will be covering 3 interesting applications of RMM (using biofluorescent particle counting and colorimetric detection of CO2). The applications are great examples on how the Pharmaceutical Industry is evaluating, implementing, and even improving RMM and start to make it happen.

    13:45 | Development of Improved Mold Recovery for Rapid Sterility Testing Using an Automated Culture System
    Dorien Ruegebrink, BASc, Microbiology Specialist, MSD
    Lori Daane, PhD, Sr Director of Scientific Affairs, bioMerieux, Inc

    14:10 | Analysis of Short-Term Variations of Microbiological Loads in Purified Water as a Valuable Tool for Root Cause Investigations: Comparison with Culture-Based Methods
    Tamara Garcia-Armisen, PhD, Sterility Assurance Manager, GSK

    14:30 | Key Lessons Learned from Ongoing Implementation of Two Automated EM Systems within Merck
    Jessica E. Long, Microbiology Specialist, Merk & Co., Inc.
    Niels JF Visschers, Senior Specialist Microbiology, MSD

    14:55 | Q&A

    15:15 – 16:00 | Networking Break and Poster Presentations in the Exhibit Hall

    16:00 – 17:30 | Concurrent Sessions

    A3:Test for Sterility: Limitations and the Future
    Moderator: Frederic B. Ayers, Advisor – Global Quality Systems, Eli Lilly and Company

    The first Test for Sterility appeared in the British Pharmacopeia in 1932 utilizing two media and there has not been significant evolution in the past 90-years. Is this appropriate for our innovative industry?

    This session will challenge current thought processes and associated methodologies associated with the Test for Sterility. Speakers will also be presenting different approaches to the realities of the Test for Sterility and how to best move the industry forward.

    The principles of parametric release are well-described in USP and in other global guidance and standards – is there a pathway for this to become the release mechanism for sterile product?

    16:00| In Pursuit of an Ideal Sterility Test: A novel Approach-Based on Raman Spectroscopy and Multivariate Analysis
    Ellen Brunbech, MSc, Principal Scientist, Novo Nordisk A/S
    Ruben A. Grosso, PhD, Postdoc, University of Southern Denmark

    16:25 | Parametric Release for Products Terminally Sterilized with Moist Heat: A Call to Action
    Kenneth Paddock, Quality Director, Sterility Assurance, Baxter Healthcare

    16:55 | Q&A with Additional Panelist
    Mike J. Sadowski, Lead Scientist, Baxter

    B3: The New Annex 1 is Coming! Are you Ready?
    Moderator: Jason L. Willett, Midwest Manager, Veltek Associates, Inc.

    Annex 1 has been under revision for quite some time and the new version is anticipated to be enacted in the Fall of 2022. As a result, facilities need to prepare. During this session we will highlight the main requirements for Annex 1 with a practical business case for implementation and compliance. We will also equip the audience with the ability to design an effective risk-based approach to cleaning and disinfection by improving contamination control, understanding expectations, and meeting regulatory requirements including Annex 1.Lastly, we will dive into a mold recovery case study detailing the tools/methods used to determine a root cause and the appropriate actions taken to prevent future occurrences. Please join us for what is sure to be an engaging session with many valuable takeaways for the audience.

    16:00 | Latest Updates on Reviewed Annex 1 and How to Move Ahead Towards its Compliance
    Rafael Beaus, Global Consultancy Manager, Azbil Telstar Technologies SL

    16:25 | Key Elements to consider for a successful Cleanroom Cleaning and Disinfection Program
    James N. Polarine, Jr., MA, Senior Technical Service Manager, Steris Corporation Life Science Technical Service

    16:45 | Mold Recovery in Grade A: What does Investigation Entail?
    Gurpreet Ganda, MS, Senior Manager, Roche

    17:05 | Q&A

    17:30 – 18:30 | Networking Reception and Poster Presentations in the Exhibit Hall

    The following posters will be presented during each break in the Exhibit Hall

    Alternative Validation of Recombinant Factor C - Materials and Methods
    Kevin L. Williams, BS, R&D, bioMérieux

    Aseptic Process Simulations in Isolators: Leveraging System Capabilities to Design an Effective Media Fill Program
    Joseph E. McCall, SM (NRCM), Director, QA Technical Services, ADMA Biologics

    Cleaning and Disinfection Success Story Over Bacterial Sporeformers – A Case Study
    Alana B. Nelson, MS, Scientist, Sr, Reslience Inc

    Comparison of Commercial Molecular Assays for Mycoplasma Detection in Cellular Therapy Products
    Anna Julia S. Adams, MSHS, MLS (ASCP)CE, Clinical Laboratory Scientist, National Institutes of Health

    Data Analysis for an Online Water Bioburden Analyzer using the SEEQ Data Analytics Platform
    Arundhati Samanta, MA, MBA, Global Product Manager- Microbial Detection System, Mettler Toledo

    Disinfectant Testing Fails
    Dan A. Klein, BS, MA, Sr. Technical Service Manager, STERIS Corporation

    Early Adoption of RMM Technologies to Enable Novel Cell Therapies for Patient Needs
    Stephane Calmat, PhD, Director - Analytical Development, SQZ Biotechnologies

    Fluid-Screen: Real-Time Microbial Contamination Detection in Biomanufacturing
    Monika U. Weber, PhD, CEO, Fluid-Screen, Inc.

    Identifying and Overcoming the Challenges of Endotoxin testing of Complex Human Plasma Derived Pharmaceutical Products
    Christoph Hansy, Associate Director / Global Sterility Assurance & Microbiology, Takeda

    Initial Experiments and Results using Raman Spectroscopy as a Non-Invasive Detection of Low-Level Contaminations in Pharmaceutical Drug Product Primary Containers
    Anders H. Sørensen, PhD, Microbiologist, Novo Nordisk A/S

    Rapid Mycoplasma Optimization
    Adam Barron, Director, R&D, Vericel Corporation

    Real Time Microbial Detection Enables Continuous Monitoring of Pharmaceutical Water for Better Process Transparency and Risk Reduction
    Peggy Banarhall, Product Manager, METTLER TOLEDO

    Review of Contamination Control Strategies Based on FDA Warning Letters
    Mirna Vazquez, BS, Associate Product Manager, Charles River Laboratories

    Sterile Hold Time Testing for Autoclaved Items Used within Parenteral Drug Manufacturing
    Renee Buthe, Technical Service Specialist, STERIS Life Sciences

    Use of a Preserved, Microbial Coated Surface (Enverify™) as a Positive Control for Environmental Sampling Performance Verification
    Mark Mulvahill, MSc, MBA, CEO, Stratix Labs

    When Less is More: Why Is One Temperature Sufficient For Environmental Monitoring Incubations?
    Laurent C. Leblanc, Microbiology R&D Manager, bioMérieux

    World Pharmacopeias are Ready to Adopt Non-Animal In-Vitro Replacement Tests for Detection of Pyrogens. Are You?
    Allen L. Burgenson, MS, Associate Director, Global SME, Lonza


    07:00 – 17:30 |Registration Open

    07:00 – 08:30 | Continental Breakfast

    07:15 – 08:15 | Breakfast Session: Current Struggles with a Panel of Experts
    Moderator: Frederic B. Ayers, Advisor - Global Quality Systems, Eli Lilly and Company

    This session will include subject matter experts that will discuss current struggles on the following topics: Aseptic Processing for Advanced Therapeutic Medicinal Products (ATMPs), Aseptic Process Simulation (APS), Container Closure Integrity (CCI), Contamination Control Strategy (CCS), Environmental Monitoring (EM), Knowledge Management, Microbiological Investigation with associated CAPA, Quality Risk Management (QRM), and Training Requirements. This will be your chance to engage and ask questions to a diverse group of Subject Matter Experts in the Pharmaceutical Industry.

    07:15 | Panel Discussion
    Ziva Abraham, PhD, CEO, Microrite, Inc.
    Angie L. Bragdon, MS, Senior Principal Scientist - Sterility Assurance Technology,Eli Lilly and Company
    Irving Ford, MSc, VP of Quality, Adaptimmune
    Stephen E. Langille, PhD, Microbiology Consultant, Valsource
    Anna F. Lau, PhD, D(ABMM), Chief, Sterility Testing Service, National Institutes of Health
    Jeff Wigton, MS, MBA,Director of Sterility and Microbiology Quality Assurance,Merck

    (Video) STERIS Workshop: Implementation of Contamination Control Strategy

    08:3010:00 | P2: Changing Dynamics in Science: Implementation by Pharmaceutical Industry and Future Adaptation
    Moderator: Simleen Kaur, MSc, Biologist, Team Lead, CBER, U.S. FDA

    Change is inevitable! Science is continually evolving and advancing. Humans and society have always been hesitant to change. Despite innovative advances in pharmaceutical microbiology, implementation of new technology and science has been slow. Specifically, advances in rapid microbiological testing methods have not been widely implemented by manufacturers, mainly due to the fear of finding unknowns and non-acceptance by regulators. Despite enhanced knowledge of novel technologies, and the concept of dynamic good manufacturing practices (GMPs for 21st Century), there is a constant struggle in adapting new innovations.

    This presentation will provide an overview of role of pharmaceutical microbiology in ensuring quality of medicines with examples of changes in microbiological methods, their implementation by the industry to build quality in the product (quality by design, QbD) for achieving sustainable compliance.

    08:30 | Pharmaceutical Microbiology in Quality of Medicines: Historical Perspectives in Achieving Sustainable Compliance through Evolving Science
    Rajesh K. Gupta, PhD, President & Principal Consultant, Biologics Quality & Regulatory Consultants, LLC

    09:30 | Q&A

    10:00 – 10:45 |Networking Break and Poster Presentations in the Exhibit Hall

    10:45 – 12:15 | Concurrent Sessions

    A4:Wouldn’t It be Nice to Have Expert Advice? Microbiological Investigations: Execution, Documentation, Confirmation, and Regulation
    Moderator: Christine Sherman, BA, Sterilization & Aseptic Processing Global Microbiology Management, Takeda

    Microbiologists gain the most experience and knowledge when events do not go as planned. Still, wouldn’t it be nice to have an expert guide to help Microbiologists navigate the investigation process? Well that help is here! Kim Sobien was part of the team that created Technical Report (TR) #88 - Microbial Data Deviations in the Pharmaceutical Industry. Kim will provide an overview of this new TR and how it can be used to create thoughtful, scientific, and compliant investigations. The second presentation of this session describes how investigational sampling was able to determine root cause in a contamination event. Steven Wieczorek will present the use of Investigational testing to improve contamination control practices by identifying hard to clean surfaces of equipment.Lastly, this session includes Regulatory Expert, RenéeBlosser, who will provide an U.S. FDA perspective on Microbiology investigations, root cause determination, and CAPA effectiveness.

    10:45 | PDA Technical Report #88 - Microbial Data Deviations in the Pharmaceutical Industry
    Kim Sobien, MBA, MSAT Contamination Control Lead, GSK

    11:10 | Improvement of Contamination Control Practices Using Investigational Testing
    Steven Wieczorek, BS, Director of Quality Control, Resilience, Inc

    11:30 | Regulatory Perspective
    Renée S. Blosser, MS, Microbiologist, CVM, U.S. FDA

    11:55 | Q&A

    B4:Getting Serious about Reducing Animal Testing
    Moderator: Friedrich von Wintzingerode, PhD, QC Lead iNeST (individual Neoepitope Specific Therapy),Genentech Inc

    More and more pharmaceutical companies are seriously considering implementation of animal-free pyrogen and endotoxin testing via MAT and rFC. While many companies are still in the planning phase, there is an increasing number of actual implementation work and increasing support by health authorities. The presentations of this session provide an interesting insight into serious efforts to implement MAT and rFC into routine QC both from an industry as well as from a health authority perspective.

    10:45 |Assessment of Recombinant Factor C Enzyme Critical Quality Attributes and Impact on Assay Performance
    Regulatory Representative Invited

    11:05 | Three years of MAT Proficiency Test Program
    Maria Gajewi, Group Leader Endotoxin Services, Microcoat Biotechnologie GmbH

    11:25 | The Assessment, Challenges, and Benefits of Implementing an Alternative Endotoxin Method with the use of rFactor C
    Emily Murphy, Senior Associate Scientist, Pfizer

    11:50 | Q&A

    12:15– 13:45 |Networking Lunch and Poster Presentations in the Exhibit Hall

    13:45 – 15:15 | Concurrent Sessions

    A5: Objectionable Microorganisms in Nonsterile Pharmaceutical Products
    Moderator: Lori L. Daane, PhD, Sr Director of Scientific Affairs, bioMerieux, Inc

    This session will take a fresh look at the long-standing issue of defining what is an objectionable microorganism for nonsterile drug products. Do the current and new regulatory guidelines reflect reality? What are the true risks to the patient and how are objectionable microorganisms determined when establishing microbial limits? Case studies will be presented on Burkholderia cepacia complex (BCC) related to recent product recalls, 483s, warning letters, and facility shutdowns. Information on where BCC is recovered, how best to confirm BCC presence, and steps to eliminate contamination and prevent its reoccurrence will be presented.

    13:45 | Objectionable Microorganisms-A Challenge or a Dilemma
    Ziva Abraham, PhD, CEO, Microrite, Inc.

    14:15 | Case Studies on Burkholderia cepacia complex (BCC) Investigations and Remediation
    Michael J. Miller, PhD, President, Microbiology Consultants, LLC

    14:45 | Q&A

    B5: The Contemporary Pharmaceutical Microbiology Laboratory: Balancing Novel Technology and Traditional Microbial Identification Methods
    Moderator: Lynne A. Ensor, PhD, Senior Vice President & Head of Regulatory Consulting Services Global Compliance, PAREXEL International

    Current pharmaceutical microbiology laboratories are often faced with the dilemma between exploring and utilizing emerging technologies versus sticking with traditional, proven, and (typically) regulatory-accepted methods. Two presentations included in this session will explore emerging, novel technology, the use of enzyme indicators (EIs), to support hydrogen peroxide decontamination qualification. The results achieved with EIs will be compared with BIs traditionally used to support qualification studies. Additionally, the advantages and disadvantages to implementing this new technology in qualification studies will be explored. A case study highlighting the use of traditional isolation and identification tools to monitor seasonal shift in a pharmaceutical manufacturing facility and their impacts on isolator bio-decontamination will be presented.

    13:45 | Enzyme Indicators: A Paradigm Shift in H2O2 Cycle Development and Qualification; Case Studies, Applications, and Forward Thinking from a Pharma Working Group
    Terrence Hollis, Sr. Manager, Global Technology and Engineering, Pfizer
    Kate M. Marshall, Global Projects Manager, Protak Scientific

    14:10 | Experiences and Practical Concepts for using Enzymatic Indicators in vH2O2 Bio-Decontamination Cycles: Advantages and Considerations of a New Technology
    Holger Kranenburg, PhD, Senior Scientist GMP Compliance, Franz Ziel GmbH
    Yemi Babatola, MS, Principal Engineer, Amgen Inc.

    14:30 | Isolator and Cleanroom Optimisation: Case Study on Inter-Related Dependencies and their Impact on Successful Isolator Bio-Decontamination
    Milind Rokade, M.Eng.Sc, PGDM, Subject Matter Expert, ProSys Group

    14:50 | Q&A

    15:15– 16:00 | Networking Break, Passport Raffle, and Poster Presentations in the Exhibit Hall

    16:00 – 17:30 | Concurrent Sessions

    A6: Aseptic Manufacturing from a Product Quality Microbiology Perspective: Considerations and Critical Concepts
    Moderator: Yeissa M. Chabrier-Rosello, PhD, Senior Pharmaceutical Quality Assessor, CDER, U.S. FDA

    Aseptic manufacturing of sterile products entails different considerations from a product quality microbiology perspective. This session will include topics centering on sterility assurance and overall product quality microbiology perspectives for aseptic manufacturing of pharmaceutical products. The discussions will include a case study on the repurposing of an isolator for aseptic manufacturing, development of an effective validation strategy for pharmaceutical clean room disinfectants and the implementation of microbiological quality level concept to assess the efficacy of the different aseptic manufacturing process controls in-place to mitigate microbial contamination during the manufacture of sterile products.

    16:00 | Repurposing a Sterility Test Isolator for Aseptic Processing in a Controlled Area
    Brian C. Patterson, Sr. Principal Scientist, Alcon Research, LLC

    16:20 | Pragmatic Approach for Facility Disinfectant Validation, 2022: Negotiating the Standards for Biologics, ATMPs, and Small Molecule Manufacturing
    Harolyn Clow, MS, SM (NRM), Manager, Quality Control Microbiology, Teva Pharmaceuticals
    Donald C. Singer, MA, Senior Microbiology Technical Consultant, North America, Ecolab Life Sciences

    16:45 | Microbiological Quality Level: A Different Way to Measure Sterility Assurance and Product Quality
    Stephen E. Langille, Microbiology Consultant, Valsource

    17:10 | Q&A

    B6: Technology: Time is now to put Alternative Methods in Place!
    Moderator: Lydia Troutman, Director Sterile and Microbiology QA, Merck & Co., Inc.

    During this session, the presentations will provide an alternative method to make WFI for pharmaceutical use supported by multiple Pharmacopeias as well as Pulsed light technology (PLT) method used at the clinical scale level to support sterile drug product component decontamination processes. Additionally, a case study will also be presented using rFC method in support of the overcoming challenges with LER.

    16:00 | Implementing Membrane-Based Water for Injection Production
    Joseph Manfredi, President/CEO, GMP Systems, Inc.
    Michael R. Pacek, PE,Mid-Atlantic and North Eastern Regional Manager, Stilmas Americas

    16:25 | Using Pulsed Light Technology to Enhance Sterility Assurance in a Clinical Scale Isolator-Based Sterile Filling Line
    Shawn D. Kinney, PhD, CEO/President, Berkshire Sterile Manufacturing
    Lindsey Lungren, MS, Manager of QC Microbiology, Berkshire Sterile Manufacturing

    16:50 | Validation of a Mitigation Strategy using a rFC-Based Method to Overcome LER
    Michael Kracklauer, PhD, Manager Endotoxin Services, Microcoat Biotechnologie GmbH

    17:10 | Q&A


    07:00 – 12:00 |Registration Open

    07:00 – 08:45 | Continental Breakfast

    07:15 – 08:30 |Breakfast Session: PDA Microbiological Control Related Publications
    Moderator: Josh E. Eaton, MS, Director, Scientific and Regulatory Affairs, PDA

    Bring your coffee and join us for an overview and discussion of recent PDA microbiology-related publications on the topics of microbiological controls for ATMP manufacturing and development of a contamination control strategy. Authors from the two technical documents will present an overview of the content and answer questions on the decision processes as to what was included in the drafting of the final product.

    07:15 | Points to Consider for Microbiological Control in ATMP Manufacturing
    Friedrich von Wintzingerode, PhD, QC Lead iNeST (individual Neoepitope Specific Therapy), Genentech, Inc.

    07:35 |Contamination Control Strategy Development in Pharmaceutical Manufacturing
    Christine Sherman, BA, Sterilization & Aseptic Processing Global Microbiology Management, Takeda

    07:55 | Q&A

    08:45 – 10:00 | P3: Innovations to Avoid an Invasive Biopsy
    Moderator: Mitch B. Garber, BS, RPh, Head of Quality Services & Compliance, 2seventy bio

    This plenary will discuss how liquid biopsy is currently being used at leading academic medical centers to support clinical decision-making, therapy selection, and management of patients with advanced cancer. Next, Dr. Carpenter will talk about the research going on in her lab that will enable new technologies to deliver improved sensitivity and accuracy of testing, thus expanding even further the clinical utility of liquid biopsy for diagnosis and management of cancer.

    08:45 | Liquid Biopsy: Recent Advances and Future Directions
    Erica Carpenter, MBA, PhD, Research Assistant Professor of Medicine, University of Pennsylvania School of Medicine

    09:30 | Q&A

    10:00 – 10:30 | Refreshment Break

    10:30 – 12:15 | P4: Ask the Regulators
    Moderators: John W. Metcalfe, PhD, Master Microbiology Reviewer, CDER, U.S. FDA and Vineeta A. Pradhan, PhD, Microbiologist, CVM, U.S. FDA

    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!

    10:30 | Panel Discussion
    Renée S. Blosser, MS, Microbiologist, CVM, U.S. FDA
    CDR Donald B. Ertel, MS, MT(ASCP), Regulatory Officer, CBER, U.S. FDA
    Erika A. Pfeiler, PhD, Supervisory Microbiologist, CDER, U.S. FDA
    ORA Representative Invited

    12:00 | Closing Remarks from the 2023 PDA Pharmaceutical Microbiology Co-Chairs

Highlighted Speakers

2022 PDA Pharmaceutical Microbiology Conference (2)

(Video) ASM Microbe Online: Opening Session

Frederic B. Ayers

Eli Lilly and Company

2022 PDA Pharmaceutical Microbiology Conference (3)

Martin Blaser

Center for Advanced Biotechnology and Medicine/RWJMS/Rutgers University

2022 PDA Pharmaceutical Microbiology Conference (4)

Ellen Brunbech

Novo Nordisk A/S

2022 PDA Pharmaceutical Microbiology Conference (5)

Erica Carpenter

University of Pennsylvania School of Medicine

2022 PDA Pharmaceutical Microbiology Conference (6)

Gilberto Dalmaso

Veltek Associates Inc.

2022 PDA Pharmaceutical Microbiology Conference (7)

Rajesh K. Gupta

Biologics Quality & Regulatory Consultants, LLC

2022 PDA Pharmaceutical Microbiology Conference (9)

Christine Sherman


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Additional Information

  • Learning Objectives

    Learning Objectives

    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
  • Who Should Attend

    • Microbiology
    • Compliance
    • Engineering
    • Laboratory
    • Manufacturing
    • Product Development
    • QA/QC
    • Development
    • Regulatory Affairs
    • Research and Development
    • Validation
    Level of Expertise
    • Executives
    • Management
    • Scientist/Technicians
    Job Function
    • Scientist/Technicians
    • Research
    • Analyst
    • Bench Personnel
    • Pharmaceutical Industry Consultants
    • Regulatory Affairs
    • Health Authorities

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Grand Hyatt Washington

1000 H Street NW
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Phone: +1 (202) 582-1234

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2022 PDA Pharmaceutical Microbiology Conference (10)

How to Get Here

By Air

Reagan National Airport (DCA) is approximately 4.2 miles from the hotel and all major carriers service this airport. Two other airports in the vicinity are both serviced by all major carriers: Dulles International Airport (IAD), 27 miles away, and Baltimore-Washington International Airport (BWI), 32 miles away.Taxi fares from DCA are approximately $25 one way, not including tip, and will take about 15 minutes. One way taxi fares from IAD is approximately $70 and from BWI about $85.

(Video) Lesson learnt on FDA citations on cleaning, disinfection and sterilization’
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(Video) Molecular sequencing and efficacv of plant extracts on fungi prevailing among water rats .

Suppliers of endotoxin LAL, Recombinant Factor C (rFC) Assays and rabbit free pyrogen test kits

Bacterial endotoxin is a key safety and quality issue for the pharmaceutical and medical device industry.. In Gram-negative bacterial sepsis, the release of pyrogenic LPS causes large amounts of inflammatory cytokines to be released, potentially resulting in toxic shock.. Gram-negative bacteria constantly synthesise LPS to replace that lost from the cell surface and when cells die they release LPS from the cell wall.. This means that tests specifically designed to detect endotoxin/LPS are essential to demonstrate the safety of pharmaceutical and medical device products.. The first method widely used to detect endotoxin in pharmaceuticals was the rabbit pyrogen test, originally described in 1925.. The gel-clot technique can form the basis of a very simple detection method by adding the reagent to a sample in a test tube and incubating at 37 o C for one hour.. Medical devices are usually tested by rinsing the surface with a standard volume of water, or a suitable diluent, and this too must be pyrogen-free.. There are a wide range of commercial test products based on LAL methodology that are focused on convenience and ease of use.. Nevertheless, rapid tests have been developed and are available commercially.. This also uses cartridges, which can be pre-loaded with reagents or accept reagents supplied by the user.. It is based on simple, low-cost gel-clot methodology and employs 'multi-beam resonator' technology in a reader unit that can produce results in as little as five minutes and is also capable of providing kinetic data.. While the LAL test remains the standard method for endotoxin testing, there are concerns over some aspects of the method that have driven the development of alternatives.. The method is not specific to bacterial endotoxin, but will also detect other pyrogens and is approved by the EP as an in vitro alternative to the rabbit pyrogen test.

Kits for Salmonella detection in foods - chromogenic media, PCR, immunoassay

Until recently, individual serovars were referred to as if they were species, for example Salmonella typhimurium .. enterica serovar Typhimurium.. In 2011, approximately 95,500 cases of human salmonellosis were recorded.. Large numbers of food ingredients and food products are routinely tested by the food industry, since the presence of Salmonella in any ready-to-eat food is not acceptable.. Almost all rapid test protocols include a selective enrichment stage, and then apply concentration and/or rapid detection techniques to replace culture on selective agars and further confirmatory tests.. Rapid methods - Many rapid confirmation and identification methods have been developed for Salmonella and a large number have been developed into commercial products.

<p>Humans are the primary source of contamination in cleanrooms.<span style="font-size: 10.8333px;"> </span>They are critical to the microbial regulation of the cleanroom and&nbsp;must be properly gowned. The primary purpose of cleanroom gowning is to protect the product and&nbsp;environment from contamination.&nbsp;When used correctly, cleanroom gowning greatly reduces the microorganisms released by personnel.</p>

All personnel are required to be properly trained and gowned before entering the cleanroom.. Scrubs and cleanroom gowning supplies (face masks, hoods, protective goggles, gloves, coveralls, and boots) should be sterile and made of non-particle-shedding material.. 1 When gowning, personnel should take care to use aseptic gowning practices.. These include gowning from the top down, wearing sterile nonpowdered gloves, and not touching the outside of the sterile gown.. An aseptic gowning qualification program should be established to assess the ability of personnel to maintain the quality of the gown after gowning.. 3 The personnel gowning qualification should be performed by an analyst who enters the aseptic cleanroom to ensure that proper gowning techniques are followed.. The 2004 FDA Guidance for the Industry on Sterile Drug Products Produced by Aseptic Processing - Current Good Manufacturing Practice states “Appropriate training should be conducted before an individual is permitted to enter the aseptic manufacturing area.. Fundamental training topics should include aseptic technique, cleanroom behavior, microbiology, hygiene, gowning, patient safety hazards posed by a nonsterile drug product, and the specific written procedures covering aseptic manufacturing area operations.. Course topics for the Stage 1 Initial Training and Education phase can consist of Personal Hygiene, Basic Microbiology, Aseptic Techniques, Cleanroom Behavior, Patient Safety, Aseptic Clothing and Gowning, Concept of First Air, Contamination Control, Facility Design, Material and Personnel Flow, Cleaning, Disinfection/Sanitization, and Sterilization, Environmental Monitoring, Process Simulations, and Specific Company Procedures.. In this training stage, the employee should have already removed any makeup and jewelry, placed on a hairnet (or bouffant), properly washed their hands, donned sterile scrubs with care, donned shoe covers, and be properly gowned to be in a Grade C area according to site procedures.. During Stage 3, general growth media contact plates are utilized to analyze whether the trainee gowned correctly without contaminating the sterile outer gown, sterile gloves, and sterile head cover.. The employee is observed gowning, and then the gowning components are sampled in several areas with the contact plates to determine the level of microbial contamination on the gowns.. Operators should be properly trained not to shout or talk excessively while gowning or while properly gowned in the cleanroom area.. All personnel entering cleanrooms must be properly trained and gowned.. It is essential to practice good aseptic technique, good hygiene, good gowning practices, good cleanroom behavior, and proper material transfer, as well as following all SOPs and not taking shortcuts.


1. Microbiological Control in a Pharmaceutical Manufacturing Environment
(Nelson Labs)
2. USP Methods for Microbial Contamination in Supplements, CBD Hemp and Probiotics
(Eurofins US Food Group)
3. Contamination control for pharmaceutical products: real-world moist heat validation pitfalls
(Nelson Labs)
4. Microbiology: Sterility testing isolators
(Tim Sandle)
5. Junior Scientists Microbiology Meeting of Marseille
(Kilian ZUCHAN)
6. EMA & FDA Expectations in Aseptic Processing
(Pharma Best Practices Webinars)

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