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Business & Regulation Quality & Compliance

A Brave New World of Quality

Biologics are expected to reach 50 percent of market share of all therapeutics within 10 years (1) and, as a consequence, demand for biologics manufacturing is at risk of growing faster than capacity (2). Companies are now actively streamlining processes to run more activities in parallel, executing manufacturing development, scale-up, and validation of processes and clinical lots much earlier in the value chain, and increasing capacity to keep up with demand. They are also exploring new manufacturing approaches, such as continuous processing and modular manufacturing.

These activities will contribute to a brave new world of medicine making, but we also need modernized approaches to quality control (QC). To keep pace with accelerated and streamlined manufacturing, QC processes must be faster, highly automated, support confident decision-making, and ensure complete data integrity. The FDA has highlighted the importance of improved QC and stated that increased investment in manufacturing quality is a critical step towards minimizing disruptions in the supply of drugs (3).

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About the Author

David Jones

Director of Technical Marketing and Industry Affairs at Rapid Micro Biosystems

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