How Does a Proven CDMO Help Early-Stage Biotechs?
Summary: While developing a drug delivered by injection, an up-and-coming biotech company ran into an all-too-common challenge: Injection site reactions and sub-optimal pharmacokinetics. An attempt to reformulate mitigated the injection site reaction, but the pharmacokinetics were still not where they needed to be.
As a contract development and manufacturing organization (CDMO) with much experience of such issues, Catalent stepped in and suggested that rather than terminate the program or try to reformulate again, they could instead use the model-based dosing approach to explore new dosing protocols. By using a modified dosing regime, the biotech found that its product could achieve an overall superior profile to the existing standard of care drug, with better tolerability.