Flexibility is an operational imperative in today’s fast-evolving biopharmaceutical industry. Contract development and manufacturing organisations (CDMOs), as integrated end-to-end service providers, need to pivot with agility by accommodating shifting product demands, modularising facilities, and continuously improving processes to be more versatile. Achieving this level of flexibility requires a strategic approach rooted in data, and that data is most effectively acquired through sustained, strategic partnerships with global pharmaceutical and biotechnology companies.
Flexibility for CDMOs can be defined as a data-driven, strategic operation. It develops incrementally as CDMOs diligently locate, analyse and apply data generated during projects for continuous improvement in operations. The data that underpins flexibility goes beyond information on batch yields or assay results. It includes project execution experience, product specifications, such as the size and configuration of bioreactors and the number of equipment and piping arrangements required for different molecules, and process know-how developed through years of hands-on problem-solving. This kind of knowledge is built in the day-to-day execution of collaborative projects between CDMOs and their biopharmaceutical partners.
Through these collaborations, CDMOs develop an understanding of numerous production requirements and challenges. Data derived from a diverse range of manufacturing processes is leveraged to continuously enhance process designs and strategies with every project. Over time, this body of data becomes the foundation for designing flexible facilities and implementing tailored bioprocesses, capabilities that enable timely adaptation to new client needs, emerging modalities and operational hurdles.