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9:00 - 9:15
Keynote: Pharmaceutical Microbiology: Current and Future Challenges
Tim Sandle, Bio Products Laboratory

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

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

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

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.

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

11:30 - 13.30
Session 6: Contamination Control

Moderator

Marsha Steed, ValSource

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