Bioprocessing in a Post COVID-19 World

COVID-19 has compressed bioprocessing timelines, leaving no room for uncertainty in the characterization of raw materials and contaminants

Bioprocessing has taken quite a remark­able journey over the last 30 years. In recent years, the demand for powerful and specific biopharmaceuticals has continued to increase, driven by monoclonal antibodies (mAbs), where the market can be expected to approach $140 billion by 2024. Rising de­mand for biopharmaceuticals also reflects how biologics are expanding into new therapeutic areas, such as neurodegenerative and cardio­vascular diseases. Finally, rising demand is be­ing sustained by better geographic reach, label extensions, and the emergence of biosimilars.

Developments in molecular biology and clinical insight have also supported emerging modalities, such as cell and gene therapies, nucleic acid–based medicines, and new workflows in engineered vaccines. As part of this next frontier of medicine, cell and gene thera­pies will continue to provide novel ways to address chronic conditions and diseases. The emergence of COVID-19, a pandemic unleashed by the SARS-CoV-2 virus, caused a rapid and unexpected evolution in the industry over the last year. As the industry has moved swiftly from research to production of new vaccines, the importance of system and raw material characterization has been magnified.

Accelerated timelines leave no room for uncertainty or unnecessary challenges related to documentation, stability, critical impurities, and other factors related to raw materials, quality, and consistency. No matter how much emphasis is placed on speed, it remains under­stood that no compromises to patient safety can be tolerated.

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