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16th May 2022  Content supplied by: Charles River Microbial Solutions

Quality Control Thought Leadership in the Microbiology World

The last week of March has some of the best weather in Charleston, South Carolina. Right in the epicenter of the downtown food and shopping scene on King Street, the annual QC Micro Summit brought quality control microbiologists from all over to discuss the latest microbiology trends, challenges, and solutions, such as regulatory changes and the use of rapid microbiological methods.

Joining us for the conference was Dr. Jack Levin – founding father of the pivotal discovery of the limulus amebocyte lysate (LAL) enzyme, the foundation of the bacterial endotoxin test. Dr. Levin discovered the gel formation of amebocyte lysate following incubation with endotoxin back in 1965. QC Micro Summit attendees were lucky enough to hear his first-hand of this personal history on the topic and how the research came to fruition. Thus, began a new era of endotoxin detection.

Dr. James Cooper, Founder of the Endosafe product line, also presented his own history of expanding LAL usage in the detection of endotoxins into the assay used by pharmaceutical microbiologists across the world. Having been involved in the first stages of the Federal Drug Administration’s (FDA) first LAL component, Dr. Cooper gave great insight into how this method was proven more efficient than the previously used rabbit pyrogen test, and why we still use the LAL method today.

Other presentations included “Becoming a Better QC Microbiologist,” presented by Phil Duncanson, Chief Microbiologist at AstraZeneca,  His humble beginnings in quality control didn’t start from a love of microbiology – but the discoveries and amazing concepts learned about the science sparked a passion for the knowledge, and the job itself. Encouraging future QC leaders to think beyond the bench and apply their scientific problem-solving skills to microbiology trends beyond the QC laboratory, attendees learned the impact they can bring to their entire company.

Michael Miller, President of Microbiology Consultants, provided attendees actionable information on the implementation of rapid microbiological methods. Not only providing guidance on the overall project, validation criteria, and on-market technologies, he also provided a valuable preview of the upcoming pharmacopeial chapters for the use of rapid methods for short shelf-life products and advanced therapy medicinal products.

Joining us once again was Dr. Ziva Abraham, sharing more of her extensive knowledge on cleanroom investigations, mold contaminations, and appropriate cleanroom design. She challenged attendees to think deeper and understand that investigations don’t occur from behind a computer screen. In order to solve for root cause, microbiologists need to investigate their facility, applying their knowledge of microorganisms to identify the source, she said.

Also on our list of expert speakers was Jim Polarine, Senior Technical Service Manager at STERIS Corporation along with Stacey Ramsey, Senior Manager Celsis Technical Services & Validations at Charles River. The two shared a talk on cell and gene therapies, more specifically about addressing fungal spore contamination in drug manufacturing cleanrooms. This presentation featured a case study discussion as well as past excerpts from FDA 483 warning letters. The talk was intended to help attendees avoid similar mistakes in their contamination control program and emphasized how the use of rapid microbiological methods is paramount in the early detection of difficult to control molds.

Giving helpful tips on how to handle pesky regulatory inspections was Vanessa Figueroa, Executive Director of Microbiology and Sterility Assurance at Quality Executive Partners .

Kim Sobien, MSAT Contamination Control Lead at GlaxoSmithKline presented virtually regarding PDA Technical Report 88 and guidance recommendations within the report.

A few other fan favorites were Paula Peacos, Senior Consultant of Microbiology at Valsource, who got the idea for her root cause analyses method from Sherlock Holmes’s basic rules of investigations. Rick Jakober, VP of Laboratory Services at Perritt Laboratories, shared insight on non-sterile microbiological testing, and how labs can cater their methods to the ever-changing regulatory landscape.

At the end of each day of sessions, attendees enjoyed several networking events to connect with their peers and interact with speakers. A favorite is always the South Carolina Aquarium night, where guests are treated to dinner, drinks, and private access to the entire aquarium. A popular spot was the horseshoe crab touch-tank, where attendees were able to pet and learn more about the habits of these creatures that we know as an important aspect of the pharmaceutical world.

Until you’re able to join us for next year’s summit, here are some of our Microbial Solutions resources that cover the latest microbiology trends.

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Date Published: 16th May 2022

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