Feeling the pressures of releasing critical human therapeutics as patient demands increase? Discover how automation can support your need for safe, rapid release of all critical therapies.
Advanced therapy medicinal products (ATMPs) such as cell therapies, gene therapies, and tissue-engineered medicines can increase the quality control demand for manufacturers, overwhelming traditional quality control (QC) microbiology labs while severely impacting patient wellbeing and commercial viability. In this webinar, viewers will learn how rapid automated methods featuring the validated Growth Direct® System can enhance QC testing processes for superior data integrity, faster decision-making, and improved patient care. Topics include:
- ATMP challenges facing today’s QC Micro Labs
- Impacts on manufacturers and patients
- Growth Direct® System overview
- Regulatory and validation issues
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David Jones, Ph.D.
Director of Technical Marketing and Industry Affairs
Rapid Micro Biosystems
With more than 20 years of experience in rapid microbial detection technology, laboratory instrumentation development, and laboratory management for European and U.S. markets, David has authored numerous papers on validation and regulatory topics. He also served on the TR33 committee establishing guidelines for validation of rapid microbiology in the pharmaceutical industry.
Prior to joining Rapid Micro Biosystems, David was manager of microbial test technologies at Wyeth Biopharmaceutical. He also held several positions at Chemunex in France, where he worked closely with the FDA and USP organizations for successful validation of rapid microbial detection systems used in water and in-process testing. He holds a degree in biochemistry from Brunel University in London and a PhD in steroid endocrinology from London University.