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Outsourcing Trends in the Development of Biologics

The development of biologic drugs continues to increase at a rapid pace. Growing numbers of conventional recombinant proteins and monoclonal antibodies, as well as next-generation molecules such as multispecifics, antibody-drug conjugates, and cell and gene therapies, are advancing through the clinic. Many of the biopharma companies behind these drugs are seeking assistance with bioprocess development from outsourcing partners with platform solutions and specialized knowledge, expertise, and technologies.


The investment equation

As demand for bioprocess development services expands and the specialized nature of those services increases, the need for CDMOs to invest in additional capacity, both equipment and capabilities, is growing.

Indeed, a CDMO has to keep up with advancing technology to best serve customers and ultimately patients, stresses Casey Franklin, vice-president of business development at Alcami. To do so requires upgrades over time. “An example would be the shift from traditional restricted access barrier systems (RABS) to isolator technology for increased sterility assurance during the fill/finish of biopharmaceutical products,” she observes.

When a CDMO takes on a specialized project, such as one involving an innovative product with special and sometimes complex requirements that creates a need for investment in additional equipment or capabilities, the investment can be fully funded by the CDMO or the customer, or a shared investment.

“There are many considerations here, including the footprint of the equipment or facility modification, the capacity required for the customer, the market demand or potential to serve other customers, the necessary expertise and staffing implications, and the stage of the program and expected long-term requirements,” says Franklin.

Impact of the capacity crunch

CDMOs always aim to maximize utilization of their facilities and equipment to stay profitable and grow, but this optimization becomes even more crucial with capacity shortages across the industry, according to Franklin. Some facilities may be able to increase capacity by implementing an extra shift or purchasing additional equipment, she notes.

CDMOs already near full utilization have to focus on effective project management and transparent communication with customers to ensure manufacturing readiness and minimize dead time due to project delays, Franklin says.

“With the supply-chain challenges and the general element of unpredictability that has come with the COVID-19 pandemic, it also helps for the CDMO and the customer to be as flexible as possible. CDMOs must keep in constant communication with customers around these challenges and work creatively to find alternate solutions when needed to keep project timelines on track,” Franklin asserts.

Partnerships make “end-to-end” support possible

It is, adds Franklin, actually difficult to find “end-to-end” CDMOs that truly function as a single provider, since so many of these organizations are born from mergers and acquisitions. “We find that many biopharma companies are more interested in forming a lasting partnership and prefer the customer focus that you more often find at smaller, more specialized firms,” she notes.

Franklin also points out that small and mid-sized CDMOs can offer the advantages of a “one-stop-shop” by teaming up with synergistic organizations.

For instance, as a fill/finish provider, Alcami focuses on drug product and analytical services, forming strong relationships with its customers and supporting them long-term in those areas. “But we also work with biologics drug substance manufacturers to understand complementary operations and processes and offer customers an efficient, streamlined approach that saves time and gets products to patients faster,” she comments.


About the author

Cynthia A. Challener, PhD, is a contributing editor to BioPharm International.

Article Details

BioPharm International
Vol. 34, No. 10
October 2021
Page: 18–23

Citation

When referring to this article, please cite it as C. Challener, “Trends in Outsourcing of Bioprocess Development" BioPharm International 34 (10) 2021. 

Casey Franklin Quote (1)