Jee Look, senior director of drug product development for Emergent BioSolutions recently contributed to an article in Pharmaceutical Technology titled, "Factoring Stability in the Biological Drug Mix."
Stability issues can also occur at any stage of a vaccine’s development lifecycle, according to Jee Look, senior director of drug product development for Emergent BioSolutions’ contract development and manufacturing organization (CDMO) business. “In some cases, instability that occurs during upstream/downstream processing can be mitigated during final drug product manufacturing, but it is important to identify and understand the mechanisms of instability early in the pre-formulation stage as instability in the final drug product would have the largest impact on patient safety and overall production efficiency and would be more costly to fix,” he says.
The instability characteristics possible with a given vaccine also depend on the vaccine type, whether it is a live virus, inactivated virus, virus-like particle, or some other type of subunit, recombinant, or conjugate vaccine. The use of aluminum adjuvants can also create different challenges with respect to vaccine stability. “It is important to understand the mechanism of action of each type of vaccine in order to design the formulation and deal with the instability issue,” Look concludes.
Read the full article here.
Vol. 44, No. 10
C. Challener, “Factoring Stability in the Biologic Drug Mix,” Pharmaceutical Technology 44 (10) 2020.