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US Food and Drug Administration (FDA) encourages implementation of the Quality by Design (QbD) principles into the production, manufacturing and regulation processes.
testing, sterilisation, and electrical checks. By inspecting the overall safety and configuration of the instrumentation, the required factory end-of-line testing is completed.
In adopting the QbD principles, every step of the process, starting from raw materials to the operating plant, clean room, and water and materials used, all should adhere to high-quality standards. Every piece of equipment used in the manufacturing process needs to meet quality requirements, such as being certified by the International Organisation for Standardisation.
Vendors also provide the relevant documentation required in adhering with the cGMP standards, for example, issuing the certificate of conformance and providing instrument calibration documentation, equipment drawing and critical component specifications. To ensure that each piece of equipment is installed per vendor specifications, meets the quality requirements, and offers consistent and reproducible results, IQ, OQ and PQ validation protocols are performed, followed by issuing the respective documentation.
Recognising the challenges posed when transitioning from research to commercialisation of cell and gene therapies, many instrument vendors apply the QbD principles and undertake all of the necessary performance testing to deliver equipment that meet the requirements of cGMP compliant facilities. Some of the steps involved in performance testing include temperature testing, ramp up/ramp down
In addition to testing for compliance and offering documentation, some vendors provide user and maintenance training to ensure best practices are upheld in the day-to-day workflow.
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Scaling out relies on having the operational capacity to accommodate all the equipment as well as the materials, manpower and time involved in the process. Planning ahead for successful cell therapy commercialisation As pharmaceutical manufacturers transition cell therapies from the research to the commercialisation phase, they start acknowledging the complexity that comes from scaling up and expanding workflows, while staying compliant with the regulatory requirements. Carefully planning cell therapy production processes beforehand, understanding the needs of cGMP compliance and collaborating with knowledgeable technology vendors who offer solutions adhering to QbD principles, can set cell therapy manufacturers up for successful commercialisation.