How To Overcome Bioprocess Development Challenges

Efficient bioprocess development is a vital objective for all biopharmaceutical developers, particularly as product demand rises. Whether the product is a recombinant protein or a vaccine, effectively achieving this goal is essential to accelerate the product to market and enable economically sustainable large-scale manufacturing in the long term.

Relatively minor mistakes during bioprocess cell line, media, scale-up, and regulatory approval stages can slow down regulatory approval and potentially lead to scale-up failures, which can cause additional delays and costs.

Given the importance of bioprocess development toward setting the pace of getting biopharmaceutical products to commercial launch, the need for this to be as successful and efficient as possible is clear. It is also clear that, regardless of whether process development is undertaken in-house or with an external collaborator, many potential challenges can arise during the process.

Fortunately, many of these inefficiencies and mistakes are due to well-known process development challenges which, once understood, can be mitigated or even avoided altogether. Successfully addressing these common challenges is key to achieving an efficient journey to market and maximizing the biotherapeutic’s potential impact.