Monday, 15 October 2018
9:00
Welcome and Introduction
Kerstin Wilken, PDA Europe
Michael J. Miller, Microbiology Consultants, Chair
Marsha Steed, ValSource, Chair
9:00 - 9:15
Keynote: Pharmaceutical Microbiology: Current and Future Challenges
Tim Sandle, Bio Products Laboratory
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OPENING PLENARY
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9:45 - 11:00
Session 1: Regulatory Update
This session will provide Regulatory Perspectives on general Pharmaceutical Microbiology with special focus on microbial testing of Advanced Therapeutic Medicinal Products (ATMPs).
Moderator
Heike Merget-Millitzer, Janssen J&J
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9:45
Microbiological Quality Control and Approval of Cell and Tissue Products
Isabelle Bekeredijan-Ding, Paul-Ehlich-Institut
10:15
Microbiological Quality Control – the Role of an Official Medicines Control Laboratory (OMCL) in Post-Market Surveillance Plans
Luis Soares, INFARMED
10:45
Q&A, Discussion
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11:00
Coffee Break, Poster Session & Exhibition
11:30 - 13:00
Session 2: Low Endotoxin Recovery and Pyrogen Testing
The bacterial endotoxins test (BET) is a critical requirement for injectable products and medical devices required to be pyrogen-free. In the July-August 2018 issue of Pharmacopoeial Forum (PF), a new chapter <1085> Guidelines on the Endotoxins Test was proposed for public comment. Recently, the Japanese Pharmaceutical and Medical Device Agency published a collaborative study demonstrating equivalence between recombinant Factor C Test (rFC) and LAL. As technologies have advanced, new test methods like the rFC and Monocyte Activation Test (MAT) have been developed and made commercially available. Therefore, the goal of this session is to discuss the challenges associated with the detection and recovery of endotoxin within our industry. Finally, share lasted technology developed and implemented in routine QC analysis.
Moderator
Walid El Azab, Steris
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11:30
The Changing Environment in Pyrogen and Endotoxin Testing & the PDA Technical Report: Low Endotoxin Recovery
Johannes Reich, Microcoat
12:00
LER Case Studies from a CMO Perspective
Priska Zenhäusern, LONZA Quality Control Microbiology
12:30
A Time-Saving Recombinant Horseshoe Crab Factor C Endotoxin Test Including a Novel Microplate
Gregory Devulder, bioMerieux
13:00
Q&A, Discussion
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13:15
Lunch Break, Poster Session & Exhibition
SIMULCAST SESSION WITH PDA USA, BETHESDA, MARYLAND |
14:15 - 15:15
Session 3: US Conference Opening Plenary
Imagine using your own body’s cells to cure cancer – the idea has recently been made tangible and has been shown to be successful with new discoveries in the field of immuno-oncology. CAR T (Chimeric Antigen Receptor T-Cell) therapy is a novel, cellular therapy that supercharges a patient’s own immune system T-cells and programs them to attack designated cancer cells in the body. Significant challenges with facility design, room classification, manufacturing, testing, and regulatory approval have been brought forth as several of these personalized “living drug” therapies have achieved commercialization. This opening plenary session will explore CAR T product manufacturing challenges from an industry perspective and discuss regulatory challenges for commercialization and the use of non-compendial microbiology methods.
Moderators
Kim Sobien, PETNET Solutions
Kerstin Wilken, PDA Europe
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14:15
Regulatory Challenges to CAR T Commercialization
Yoko Momonoi, Regulatory CMC, Celgene,
speaking from Bethesda
14:45
FDA Perspectives on CAR T Commercialization
Kimberly L. Schultz, CBER, US FDA, Invited,
speaking from Bethesda
15:15
Questions and Answers/Discussion
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15:45
Coffee Break, Poster Session & Exhibition
SIMULCAST SESSION WITH PDA USA, BETHESDA, MARYLAND |
16:15 - 16:45
Session 4: Current Regulations in EU and US
Current regulatory and inspection trends will be the focus of this very popular session and this year we are fortunate to simulcast presentations from both European and the FDA representatives. Renowned MHRA microbiology expert and GMP inspector, Andrew Hopkins, will provide an update on the long-awaited revision to Annex 1, Manufacture of Sterile Medicinal Products. Justin Boyd, an investigator in the Office of Regulatory Affairs with FDA's Team Biologics. will present an overview of recent investigational findings and discuss some of the most significant non-compliance issues facing the industry.
Moderators
Michael J. Miller, Microbiology Consultants
Julie Barlasov-Brown, Merck & Co., Inc.
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16:15
Microbiological Implications of the EU Annex 1 Revision
Andrew Hopkins, MHRA, speaking from Berlin
16:45
US Inspection Trends
Justin A. Boyd, US FDA
speaking from Bethesda
17:15
Questions and Answers/Discussion
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18:00
End of Day 1 and Networking Reception
Tuesday, 16 October 2018
9:00 - 11:00
Session 5: Current Advances in Alternative and Rapid Microbiological Methods
This session will address future trends in different areas of microbial testing to improve speed, efficiency and performance of testing. The session will also provide insight into Next Generation Cell Analysis, a new non-invasive method without any sample preparation, labeling or staining.
Moderator
Heike Merget-Millitzer, Janssen J&J
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9:00
Mycoplasmas in Biopharmaceutical Production Processes: Risk Assessments as Basis for Validation and Implementation of PCR Methods for Mycoplasma Safety Testing
Renate Rosengarten, Mycoplasma Biosafety Services
9:30
Evaluation of Scientific Advances to Improve the Performance of Identification Options for the Laboratory
Prasanna Khot, Charles River Labs
10:00
Label-free and Non-Invasive Single Cell Analysis Using Raman Spectroscopy
Karin Schütze, CellTool
10:30
Q&A, Discussion
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11:00
Coffee Break, Poster Session & Exhibition
11:30 - 13.30
Session 6: Contamination Control
Moderator
Marsha Steed, ValSource
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11:30
Microbiological Control Strategy – Development of a Standardized Risk Assessment Tool to Enable a Harmonized Approach for Environmental Monitoring
Heike Merget-Millitzer, Cilag Janssen J&J
12:00
Moist Heat Sterilization and its Biological Validation: From Rules to Practice
Maria Luisa Bernuzzi, Fedegari Autoclavi
13:00
Case Studies of New Methods of Contamination Elimination and Prevention
Brian G. Hubka, Contamination Prevention Technologies
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13:30
Lunch Break, Poster Session & Exhibition
SIMULCAST SESSION WITH PDA USA, BETHESDA, MARYLAND
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14:30 - 16:30
Closing Plenary: Creative Solutions for Contamination Detection and Control
For this EU closing session, we will look at alternative solutions to contamination detection & control. Our two speakers are well-known on both continents for their long experience in pharmaceutical microbiology, investigations & troubleshooting, and their passion for alternative micro methods. Dr. Michael Miller will present an overview of the more recent revision of regulations and guidances to define strategies for short-shelf lives medicines such as Cell & Gene Therapy products. Jeanne Moldenhauer will focus on the infamous Burkhoderia cepacia complex and novel methods for eradication of this contamination as well as preventative measures. Those two passionate speakers will enrich their presentations with real case studies.
Moderators
Olivier Rocher, GSK Vaccines
Amy McDaniel, US FDA |
14:30
Regulatory Strategies and Case Studies for Rapid Sterility Testing of Gene and Cell Therapy Products
Michael J. Miller, Microbiology Consultants
15:00
Case Studies with Burkholderia Cepacia Complex (BCC)
Jeanne Moldenhauer, Excellent Pharma Consulting
15:30
Questions and Answers/Discussion
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16:00
Closing Comments and Farewell
16:30
End of Conference