Drug Development & Delivery: SPECIAL FEATURE – Outsourcing Formulation Development & Manufacturing: Connecting Your Project to the Right Service Provider

The global contract development and manufacturing organization (CDMO) market size was valued at $255 billion in 2025 and is projected to grow from $273.40 billion this year to almost $581 billion by 2034. 1 Growing focus on precision medicine, the ability to handle more complex formulations, and a recent interest in highly potent active pharmaceutical ingredients is driving CDMO demand.

To be more efficient, CMDOs are turning to AI and data-driven tools. These technologies play a more practical role in formulation development and manufacturing, particularly in analyzing historical datasets and informing experimental design. While AI isn”t replacing scientific expertise, it is helping teams review larger datasets faster and make more informed decisions.

Many of the leading CDMOs highlight their capabilities and share real-world examples of how they solved clients” formulation and manufacturing challenges in this exclusive Drug Development & Delivery annual report so that you can find the right provider for your own project.

Abzena: Two Approaches to Formulation Studies

Abzena offers formulation development services that cover every stage of drug development, from early stages of candidate selection through first-in-human studies, commercialization, and any further life-cycle management as required.

Abzena applies two general approaches to formulation studies. Its “Fast-to-Clinic” approach is a streamlined methodology focused on enabling the customer to rapidly obtain FIH results in the shortest time possible. A “Best-in-Clinic” approach is focused on providing a superior product format often applied post Phase 1.

“With the expansion of next-generation, highly complex biologic and bioconjugate drugs, we have seen an increasing demand for formulations aligned with maximizing stability and developing high-concentration forms,” says Gary Watts, Head of Formulation, Abzena.

“Where developers are adding multiple functions through bi/multi-specific formats, or conjugating novel cargos to antibodies, there can be an inherent instability that requires a more considered formulation approach,” he says. “We have also seen a requirement for high-concentration formulations for the rapidly growing area of antibody-oligonucleotide conjugates (AOCs), where a high frequency of high doses are often used to treat patients.”

To illustrate these approaches in action, Mr. Watts points to a customer that went “Fast-to-Clinic” with an IV formulation for an antibody in early-stage first-in-human trials. Clinical and competitive data analysis highlighted the need for a high-concentration formulation for SC administration. While the target concentration of 150mg/mL was stable, it exhibited a high degree of viscosity, significantly exceeding the acceptable limit for standard SC injection devices, he says.

Abzena’s formulation team undertook a systematic screening process to identify viscosity-reducing excipients to identify and test a selected panel of buffers and excipients to modulate protein-protein interactions without compromising stability. “A formulation was successfully developed that reduced the viscosity within the acceptable range for SC injection,” he says. “Furthermore, stress testing confirmed that the selected composition did not introduce instability; in fact, it marginally improved the protein’s resistance to aggregation under accelerated conditions, allowing the product to progress successfully to later clinical studies.”

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