SPONSORED BY: Associates of Cape Cod, bioMérieux, Lonza, Microcoat, Mettler Toledo & Millipore Sigma

Co-chairs:

• Jim Polarine, Senior Technical Service Manager, STERIS Corporation &
• Geeta Singh, Sr. Plant Technical Specialist, Genentech

Novel Approaches and Best Practices for Tackling Current Industry Contamination Control Challenges

Following on the success of the last West Coast event, SMi proudly presents the 4th Pharmaceutical Microbiology West Coast Conference, as a virtual conference on June 17th and 18th 2021 bringing microbiology experts to focus on innovations in rapid methods and contamination control strategies. Microbes such as bacteria, fungi, parasites, and viruses that can contaminate current and novel pharmaceutical products or therapies may stem from various sources such as raw materials and human operators, are taken into consideration.

This concern is critical in advanced products/therapeutics facilities where often distinct areas within manufacturing are slowly merging, providing potential new sites for contamination events. The conference showcases sessions that cover alternative endotoxin testing and rapid mycoplasma testing as well as the implementation of in-line bioburden monitoring to control water systems, to name a few. Due to the complexities brought about by more advanced therapeutic products, both drugs and patients are time-dependent and rapid methods are ever more desired.

A significant portion of the conference will focus on contamination control strategies and facilities support/novel technologies such as a look at a sustainable global contamination control program, cleanroom pass thru best practices, and a case study executing the rapid transition from clinical to commercial manufacturing and more. Also see a regulatory session discussing objectionable organisms in non-sterile drug products and an all-women panel discussion: ‘culturing’ successful women microbiologists.

Event Hashtag: #SMiPharmaMicroWC

• Discuss the guidance, regulations, and case studies for objectionable organisms in non-sterile drug products from ValSource, Inc.
• Gain insight into changing paradigms – moving to in-process testing from Johnson & Johnson
• Examine alternative endotoxin test methods for products exhibiting LER from Amgen
• Explore how to effectively scale up from clinical to commercial in three moves from Bristol-Myers Squibb
• Join us for our Panel Discussion on ‘Culturing’ successful women microbiologists
• Discover myths, mistakes, and consequences in non-viable particle monitoring from Microrite
• Learn how to build a Global Contamination Control Program with Takeda
• Virtual Conference Benefits include virtual exhibition booths packed with information, networking features to chat and share contact details with other attendees, and virtual meetings and networking socials

Plus 2 half-day interactive workshops on Wednesday, June 16th, 2021:

Workshop A: Data Integrity in Environmental Monitoring: Causes and Solutions

Led by: Ziva Abraham, CEO, Microrite and Morgan Polen, SME, Cleanroom Contamination Control Expert, Microrite

Workshop B: Master Class: Pharmaceutical Microbiology for Non-Microbiologists

Workshop Leaders: Dr. Ed Balkovic, Subject Matter Expert Microbiologist (retired), Contamination Control Department, Sanofi Genzyme

View the full agenda

WHO SHOULD ATTEND?

Senior Microbiologist, Lead Scientist, Laboratory Manager, QA Specialist Drug Substance External Manufacturer, Business Development Manager – Testing, Pharmaceutical Microbiology Consultant, Higher Pharmacopoeia Scientist, Analytical Standards Specialist