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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).

A critical cornerstone of QC is environmental monitoring and in-process testing for microbial contamination. Current processes to detect microbial contamination are time- and labor-intensive; we need faster, better technology. Consider continuous manufacturing where drugs move through an integrated production workflow, without hold times between steps. The FDA calls the conversion to continuous approaches a “challenging but worthwhile transition (4).”  While both batch and continuous manufacturing are subject to the same QC standards, however, monitoring is more frequent and must be automated in continuous manufacturing facilities to keep pace with production.

With continuous flow processes, the more rapid the turnaround of environmental monitoring and in-process testing, the better – these tests will identify a process that is going out of control and enable a quicker response. In addition, many of the raw materials used in the manufacture of biologics are expensive, and the ability to rapidly detect contamination will help reduce the risk of lost investment.

The use of modular cleanroom production facilities also benefits from rapid, automated QC processes. In contrast to conventional facilities that require significant capital outlay and long construction times, modular facilities are complete, turnkey units that are designed, validated and assembled off-site. Skid-mounted platforms in these facilities enable reconfiguration and upgrades without the costs and time requirements of major renovations. The environmental monitoring strategy can be identified before the installation of the facility, further accelerating deployment. This process includes the determination of high and low-risk contamination areas, the possible impact on the process, and identification of where to test and how. Automated QC systems for environmental monitoring and in-process testing can further increase the flexibility of modular manufacturing. These systems can be integrated into manufacturing, eliminating the need for a separate QC module. In this scenario, trained members of the manufacturing staff can feed samples into the automated QC system. The adoption of an automated approach for QC can also accelerate validation in terms of environmental monitoring, bioburden, and water systems. Integration of automated systems also eliminates the need for incubators and peripheral equipment, further reducing the time required for validation. 

In addition to supporting new strategies, such as continuous processes and modular facilities, rapid and automated QC processes also enable wider adoption of digitization, where sensors and chemical testing methods are placed along the manufacturing line. As QC data come off the line, operators can respond more rapidly to process deviations. Automated QC processes provide an electronic output of data and can deliver a real-time display of conditions within the manufacturing facility, identifying possible hotspots of contamination with greater agility.

Conventional methods of manufacturing will continue to evolve – and drug manufacturers will embrace new technologies and workflows capable of delivering gains in speed, efficiency, and capacity, while preserving quality and data integrity. But if we, as an industry, are truly aiming for improved speed, patient safety, and reduced business risk in the years to come, then we cannot neglect innovation and implementation of modern QC approaches.

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  1. IQVIA, “Disruption and maturity: The next phase of biologics” (2017). Available at https://bit.ly/2XmMNpw.
  2. Biospace, “CPhI Annual Report predicts Europe to surpass the USA in biologic manufacturing capacity by 2023” (2019). Available at https://bit.ly/30oY5eO.
  3. FDA, “To Help Reduce Drug Shortages, We Need Manufacturers to Sell Quality — Not Just Medicine” (2020). Available at https://bit.ly/3k6gl4m.
  4. FDA, “Modernizing the Way Drugs Are Made: A Transition to Continuous Manufacturing” (2017). Available at https://bit.ly/2D5cpQZ.

About the Author

David Jones

Director of Technical Marketing and Industry Affairs at Rapid Micro Biosystems

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