The number of technology platforms utilized in the chemical synthesis of actives, intermediates and other complex substances across pharmaceutical and biotechnology markets has rapidly expanded since 2000. Prior to that time, most small molecule APIs were relatively simply, and could be manufactured with ‘classical’ chemistry technologies. However today, many small molecule APIs in clinical development require multiple advanced technologies for a single synthetic sequence.
Examples include high potency APIs, continuous processes, synthesis and conjugation with PEGs and mPEGs, carbohydrate chemistry, polymer APIs, microbial fermentation, biocatalysis, and cryogenic chemistry. It is challenging for any single pharmaceutical company or contract manufacturing organization (CMO) to develop a portfolio of advanced technologies that can accommodate the needs of all process steps involved in the production of such complex APIs.