Large molecules require special handling procedures for bulk drug substance, formulation, and sterile filtering and filling of the final drug product, forcing change on many levels of the manufacturing process.
Development of novel custom active pharmaceutical ingredients (APIs) is increasingly turned over to outsourced partners who have become the primary drivers of the product’s overall development and go-to-market strategy. With hundreds of potential partners that drug owners can choose from to develop and manufacture custom API, choosing the best partner can be a challenging task. In this white paper, we explore the importance of purposefully aligning the overall drug development strategy with a partnering strategy.
While traditional small molecule drug products usually consist of pure chemical substances that are easily analyzed after manufacture, biologics such as monoclonal antibodies (mAbs) are much more complex.