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Keeping Control

The inherent complexity of biopharmaceutical products presents an ongoing challenge for manufacturers, particularly in the drive towards continuous manufacturing operations. Key obstacles include the optimisation of both molecular and product characterisation and process control, all while delivering the highest levels of quality and product consistency. Biopharmaceuticals can be very difficult to characterise and control; however, in an industry where products are designed for patient consumption, it is critical to assure safety, purity, efficacy, and the specific functionality of a substance. Therefore, the biopharmaceutical must be accurately characterised in a reproducible, commercially-viable way.

Delivering these necessary attributes is also a primary focus for regulatory bodies to safeguard the end consumer, and, in response, governments are tightening up their biopharmaceutical regulations. To provide regulators with the assurance of consistent quality, it is critical that adequate control strategies are implemented and continuously reviewed. The challenges associated with applying those to complex biopharmaceuticals should be addressed, as well as the key role miniaturised mass spectrometry plays as a tool to support advancements in quality assurance for manufacturers.

Dr Richard Moseley at Microsaic Systems (July 2019)

Keywords: biopharma Manufacturing process control poduct characterisation

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