Key Considerations To Ensure Product Stability And Patient Safety In Aseptic Fill/Finish Manufacturing

By John Thomas, Samsung Biologics

Heightened demand for drug product (DP) capacity and supply chain uncertainty are among the factors that have combined to strain many fill/finish (F/F) providers’ facilities, personnel, and equipment. Even amid heightened demand, the rise of increasingly costly biologics means downstream F/F operations must be uncompromising in providing high-quality results and cost-effectiveness, while ensuring quality standards and regulatory requirements are met or exceeded. In response, not all CDMOs have been able to meet the challenges of aseptic processing and sterile F/F operations on a clinical and a commercial scale.

As the global biopharmaceutical market grows toward an expected $856.1 billion (USD) value by 2030, biopharmaceutical drug developers must identify CDMO partners agile enough to meet changing industry needs, including smaller batch sizes, more cost-effective processes, and accelerated time to market. Those vendors also must be able to keep pace with more intense F/F capacity demand.

Samsung Biologics provides end-to-end F/F services ranging from early-phase formulation development, clinical filling to high-volume commercial filling, including secondary packaging and labeling/serialization for DP of both mAbs and mRNA products. We excel by working closely with our clients to achieve greater speed to market and safe, global distribution — minimizing clients’ logistical hurdles and distribution costs — driven by continuous investment in initiatives that facilitate high product quality with more process flexibility. Moreover, our clients’ success is propelled by Samsung Biologics’ dedicated DP Manufacturing Science and Technology (MSAT) team for technology transfer and production.