Issue link: https://www.e-digitaleditions.com/i/1499694
24 BioPharm International ® Partnerships for Outsourcing eBook May 2023 www.biopharminternational.com C ontract development and manufacturing organizations (CDMOs) specializing in ster- ile fill/finish were key to the success of the COVID-19 vaccine roll-out, delivering aseptic manufacturing capacity and expertise. But can CDMOs do better in the future? What lessons can be learned to fur- ther speed up sterile processing for the next pandemic? Reflecting on the past 24 months The development and commercialization of effec- tive vaccines to tackle the COVID-19 pandemic hap- pened at an unprecedented pace and on an unparal- leled scale. Billions of doses of a range of approved vaccines have now been administered to patients across the globe. Millions more continue to be man- ufactured to provide boosters capable of tackling new variants in an effort to prevent a repeat of the events of spring 2020. Vaccine spending worldwide was higher in 2021 than any previous year (1). Total cumulative spending for the COVID-19 vaccine program is forecast to hit $157 billion by 2025 (2). The past two years have demonstrated that it is pos- sible for the pharmaceutical industry to achieve new heights of speed and efficiency in development and manufacturing, all while maintaining optimum levels of quality and safety. Key to this achievement was the level of collabora- tion between companies within the pharmaceutical ecosystem. Another significant factor was the greater willingness to outsource key aspects of the develop- ment and manufacturing process to CDMOs. This included outsourcing the aseptic fill/finish of the vaccine formulation into vials ready for shipping. Out- sourcing this sterile filling to experts with the specialist sterile infrastructure already available allowed the de- livery of billions of high-quality doses of vaccine at high speed, enabling drug developers to meet global demand. However, the successful roll-out of the COVID-19 vaccines over the past two years does pose a challenge Fill/Finish Lessons Learned from COVID-19 Roberto Raffaele Addamo, is head of Commercial, Sterile Fill & Finish at Recipharm. Can CDMOs apply lessons learned from the COVID-19 pandemic to improve sterile processing? IM IMAGERY - STOCK.ADOBE.COM