For cellular therapeutics, manufacturing is part of the product. Changes in raw materials, culture conditions, equipment or processing parameters can potentially influence biological characteristics.
The manufacturing strategy therefore applies pharmaceutical-quality principles throughout the product lifecycle.
The quality framework may encompass:
Manufacturing infrastructure is being developed around relevant PIC/S GMP principles for medicinal and advanced-therapy manufacturing.
Particular attention is given to areas such as:
Controlling the manufacturing environment because viable cellular products generally cannot undergo conventional terminal sterilization, contamination prevention must be integrated into facility design and operating procedures.
Controls may include:
Release Based on Defiend Specifications
Relevant testing may include:
Identity
Confirming the intended cellular population.
Viability
Evaluating viable cell recovery.
Purity
Monitoring unwanted cellular or process-related components.
Sterility
Assessing microbial contamination.
Mycoplasma
Testing for a critical biological contamination risk.
Endotoxin
Evaluating pyrogen-associated contamination.
Genetic Stability
Monitoring cellular integrity during expansion.
Potency
Evaluating defined biological functionality.
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