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The bio/pharma outsourcing industry continues to be integral in the development and manufacture of medicines.
The bio/pharma outsourcing industry continues to be integral in the development and manufacture of medicines. Contract research organizations, contract development and manufacturing organizations (CDMOs), and contract manufacturing organizations assist drug sponsor companies in bringing their products to market. These contractors offer the experience and resources some drug companies may lack to develop and manufacture drug products.
Outsourcing processes appears to be on the rise. When it comes to biopharmaceuticals specifically, BioPlan Associates states that more than half of biomanufacturers (65%) outsourced bioprocessing tasks in 2022, which is up 23% from 2006. The research company also predicts this trend will continue, citing that 79% of respondents to a 2022 survey have indicated they will be outsourcing some of their operations by 2027 (1). Analytical testing and toxicity testing were the most typical outsourced activities in 2022, according to BioPlan (2). “As the industry has become more complex, with increasingly advanced technologies, such as cell and gene therapies, in some cases, the need for the skills available from specialized CDMOs is indispensable,” said Shriya Bhatkhande, research associate with BioPlan Associates (2).
According to Ashley Wentworth, senior director, Vault Quality at Veeva Systems, contract partnerships are also entering the quality control space, with some companies collaborating with contractors in quality management. “Others, too concerned about security and data access, shied away from this approach. This, however, will change,” Wentworth said (3). In addition, contractors bringing suppliers into quality management systems will make acceptance, sign off, and approval of products easier, according to Wentworth. “Over time, companies will develop distinct information-sharing strategies, training programs, and new processes tailored to each partner” (3).
These and other outsourcing trends, such as fill/finish for messenger RNA therapies and technology transfer, are discussed in Pharmaceutical Technology’s® Bio/Pharma Outsourcing Innovation eBook, published in February 2023. The eBook can be found on PharmTech.com.
Susan Haigney is managing editor of Pharmaceutical Technology.
Vol. 47, No. 3
When referring to this article, please cite it as Haigney, S. Outsourcing Still Vital. Pharmaceutical Technology 2023 47 (3).