The considerations for selecting the best expression system for your biopharmaceutical product are pertinent to biotechnology companies looking toward a transaction based on that product or a larger company seeking to undertake complete development and commercialisation. Whether a biotechnology company is looking to out-license the product, sell the product outright, use it to catalyse an IPO, sell the company or secure a further private round of investment, in all cases, transaction success will be dependent on passing detailed due diligence. Commercial and technical viability of manufacturing the product at scale is a critical component of such due diligence, and a suitable manufacturing strain with a viable and detailed CMC package is a core part of this.
In addition to the success of a new biological therapeutic advancing through the stages of clinical development, the necessity for a suitable manufacturing strain also applies to other commercial situations. Biosimilars, biobetters, improved vaccines or repurposing of existing regulated biological therapeutics for new indications are all further commercial instances where the disciplines of selecting the most appropriate expression system apply. Typically, the advantages of a fully optimised production strain are significantly greater when entering an existing market, e.g. with a biosimilar competing against the originator biologic, or when expanding the market to treat new indications. Consequently, selecting the most advanced expression platform suitable for the specific biologic at the time is more likely to gain greater market share than replicating the expression system used for the original manufacturing process.
