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.
Decisions regarding the bioprocess cell line, media, scale-up, and regulatory approval can have direct effects on overall product speed to market and costs. Relatively minor mistakes during these 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. Gaining this knowledge and successfully addressing these challenges can reduce risk, dramatically increase the likelihood of successful process development, and accelerate the delivery of innovative new treatments to the patients who need them.