Evaluation of drying technologies for storage and shipment of recombinant protein drug substance

摘要

With growing markets and increasing pipelines, biotechnology companies face a supply chain challenge to manufacture and distribute products using economically feasible methods that protect protein integrity. Adequate storage and shipment of drug substance is an important operation and product quality issues are dependent upon success at this stage of the manufacturing process. While cryopreservation technologies are widely in use today, they may become prohibitively expensive in the future due to increasing product volumes and high operational costs.This thesis presents an evaluation of drying technologies as an alternative to cryopreservation for recombinant protein drug substance storage and shipment. After presenting an assessment of current cryopreservation technologies, the potential of drying technologies to protect protein integrity is examined through process optimization and product characterization at laboratory scale. The economic impact of such technologies and the implications of their implementation in the manufacturing environment are discussed. Recommendations on storage technologies for drug substance are proposed based on results of the analysis. Finally, the thesis builds on this particular study to research the specifics of process development in the biopharmaceutical industry and to discuss implications for future process innovation.