Regulatory Approval of Three Rapid Microbiological Methods for MACI Product Release
08th November 2018 | 10.00 am EDT | John Duguid Senior Director, Research & Development at Vericel Corporation and Nicola Reid, Senior Product Manager at Charles River |WATCH FOR FREE
Rapid detection of contaminants is essential for cell therapy products with short shelf lives. Integrating quality into the process through lot segregation, raw material qualification, environmental control, personnel training, and detailed procedures is critical because final results for conventional microbiological tests may not be available prior to product release or patient administration. EMA approval of the MACI MAA in 2013 followed by US FDA BLA approval in 2016 included three RMM product release assays for sterility, endotoxin, and mycoplasma.
Presented by John Duguid Senior Director, Research & Development at Vericel Corporation
John Duguid is Senior Director, Research & Development at Vericel Corporation in Cambridge, MA. Vericel Corporation acquired Genzyme’s Cell Therapy and Regenerative Medicine (CTRM) business in 2014. As a Principal Scientist, Mr. Duguid was responsible for developing, validating, and transferring molecular biology assays for rapid microbiology and cell differentiation applications, managing complex projects to implement process changes, and using statistical process control tools to implement process analytical technology for cell therapy products. He has been with CTRM since 1995.
Before taking on his current role in R&D, Mr. Duguid managed quality control cell therapy operations at Genzyme for over 10 years, where he designed and implemented a comprehensive cGMP-compliant raw material program controlling 300-400 parts and participated in 16 vendor audits, directing 4 as lead auditor. He also represented QC during 10 FDA inspections and numerous audits from international regulatory authorities as a subject matter expert in material inspection and release, biopsy accessioning, endotoxin testing, Mycoplasma testing, analytical methods, flow cytometry, laboratory failure investigations, assay validation, and data management.
Mr. Duguid received his Bachelor of Science degree in chemistry in 1986 from the University of Michigan in Ann Arbor, MI and taught analytical chemistry in 2000 at Northeastern University in Boston, MA. Prior to joining Genzyme, he worked in analytical research at Abbott Laboratories’ Pharmaceutical Products Division in North Chicago, IL and then as a scientific consultant for Massachusetts biotechnology companies at Arthur D. Little in Cambridge, MA. Involved with the pharmaceutical and biotechnology industries for over 20 years, Mr. Duguid has technical and management experience spanning all phases of the product lifecycle from early research and development through cGMP quality operations.
Followed by Data Integrity: Eliminating Risk & Human Error by Utilising Cartridge Technology
The human element can never be completely eliminated in Bacterial Endotoxin Testing, but what can be done to mitigate the risk for human error and how does it relate to the data integrity problem?
Reducing the risk for human error in our manufacturing and laboratory processes will ensure that we comply with data integrity laws and regulations while building quality into our everyday processes and thus keeping our patients and our drugs safe. As laboratory testing shifts from observation-based qualitative methods to more objective quantitative methods, focus on data integrity becomes more critical to ensure overall product quality and patient safety.
We’ll apply those principal to an invalid BET example to see how the result can potentially cripple your manufacturing timelines. There’s no mistake that the LAL assay is the gold standard for endotoxin testing, and advances in science have allowed for improvement in how it’s utilized. The end result is the revolutionary cartridge technology.
Endosafe® cartridge technology is the innovative response to the customers’ need for higher sensitivity and faster quantitative results. Designed to optimize and refine the use of LAL, the cartridge technology eliminates a significant amount of the raw material and accessories required for traditional LAL methods while reducing time-consuming preparation and technician variability
Presented by Nicola Reid, Senior Product Manager at Charles River – Microbial Solutions
Nicola Reid is the Senior Product Manager for the Microbial Solutions division of Charles River Laboratories. She has approximately 20 years experience with the Bacterial Endotoxin Test and Pharmaceutical Microbiology, during which time she has been involved in all aspects of the endotoxin assay, including the design and development of BET-specific instrumentation and software. She has directed workshops and training courses and lectured internationally on a variety of BET-related topics, including LAL methodologies, product validations, 21 CFR Part 11, and BET regulatory affairs. She now works as part of the Product Management to ensure we are building products to our customer’s requirements/expectations and working on innovations for the future.
Sponsored by Charles River
For 30 years, Charles River has been dedicated to the development of precise, robust micro QC solutions that help bring your products to market safely and efficiently. Our mission is to provide industry-leading scientific and technological advances that not only meet ever-changing regulatory guidelines, but set a new standard in the way you perform testing. We’ve purposely built our portfolio to bring you progressive products and services that deliver accurate, relevant and measurable data to fuel confident decisions on product quality for release. Our unique combination of Endosafe® endotoxin testing, Celsis® rapid microbial detection and Accugenix® microbial identification and strain typing keeps your manufacturing operations running efficiently and smoothly, lowers your cost to manufacture and protects your reputation.