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4 Pharmaceutical Technology ® Bio/Pharma Outsourcing Innovation eBook 2023 PharmTech.com VITALII VODOL AZSKYI - STOCK.ADOBE.COM H istorically, in the early days of bioprocessing, the use of outsourcing to a contractmanu- facturer had been considered a less-than- optimal way to build a biopharmaceutical company. However, as attention has shifted toward improving efficiency, this has changed. The bio- pharmaceutical industry has increased its reliance on contract manufacturers over the past decade for a variety of reasons. One of t he fac tors i ncrea si ng t he dem a nd for contract development and manufacturing organi- zations (CDMOs) and greater outsourcing is the in- dustry's focus on productivity and efficiency. Some operations and bioprocessing activities can simply be done more effectively by organizations that special- ize in those operations. As the industry has become more complex, with increasingly advanced technol- ogies, such as cell and gene therapies, in some cases, the need for the sk ills available f rom specialized CDMOs i s i nd i s pen sable. Accord i ng to t he 19th A nnu al R e p o r t an d S ur ve y o f B i oph ar m a ce ut i cal Manufacturing Capacit y and P roduction by BioPlan Associates i n 2022 (1), 65% of bioma nufac t urers today outsource at least some of their bioprocess- ing. This compares with only 42% outsourcing in 2006. The trend over the past 17 years has been very consistent—each year fewer facilities are relying solely on their in-house capabilities. And over the next five years, this trend will continue, with 79% of respondents indicating they plan to outsource at least some of their operations by 2027 (1). Outsourced activities in biopharmaceutical manufacturing W h i le t he specif ic activ ities t hat are outsourced f rom compa ny to compa ny d i f fer, out sou rc i ng is still a prevalent and vital practice. Fill/finish, an- aly tic testing, sterilit y, and of ten routine testing Biopharmaceutical Manufacturing Growth Shriya Bhatkhande is a research associate at BioPlan Associates. Growth in outsourcing has been the result of COVID-19 projects taking precedence, which has pushed some contract manufacturing to second-tier CDMOs.