Cell & Gene QC Whitepaper Available for Download

Making good on the life-altering promise of cell and gene therapies is only possible for pharmaceutical manufacturers who first overcome the quality control (QC) limitations of traditional microbiology testing labs. Today’s advanced therapy medicinal products (ATMPs) have the potential to multiply testing requirements, overwhelming QC micro labs and causing bottlenecks with disastrous real-world consequences for patients. So any organization hoping to capitalize on rising global demand for ATMPs must come to grips with a variety of unique challenges:

• More complex manufacturing processes and greater demands on environmental, personnel, and bioburden monitoring
• Scale-up difficulties, especially for autologous cell therapies
• Reducing “vein-to-vein” timelines for patients in urgent need
• Required QC micro testing for lot release

Rapid Micro Biosystems recently surveyed a variety of today’s in-demand therapies and the pitfalls they pose for traditional QC workflows, identifying automated rapid microbial methods (RMMs) that can drastically reduce your dependence on manual testing while increasing throughput, accelerating time-to-result, and shrinking volumes of paperwork. Along the way, we also spoke with experts such as Irving Ford and Marc Glogovsky about where the industry is headed and what to expect from regulators. 

The result is a new whitepaper, Adapting QC Microbiology Labs for the Demands of Cell & Gene Therapies. To take your next step forward and capitalize on the coming wave of cell and gene therapies, download this thought-provoking whitepaper today.

Our experts are happy to discuss improving your QC microbiology lab’s efficiency with the Growth Direct^® System. CONTACT US NOW.