Next Generation Conjugates: Process And Analytical Challenges

By YomadisOrtiz-Barbosa, Melissa Ritchie, Sowmyan Sreenivasaraghavan, PetroslavChipinski, and Jason Schaffer

Recent advancements in Bioconjugation technology have enhanced selectivity and efficacious outcomes for diseases previously considered untreatable or inadequately treated by conventional antibody drug conjugate (ADC) therapies.

Now referred to as 'Next Generation Conjugates,' these new technologies are increasingly representing various development stages for diverse indications, underscoring the demand for clinical supplies.

Delivering GMP-quality clinical products presents new challenges in both process and analytical development. Process chemistry operations must ensure a specific distribution of linker-payload to the antibody and deliver a pure, formulated drug substance at kilogram scale. Robust analytical testing is crucial for defining key quality attributes and determining product stability.

As an industry leader, MilliporeSigma provides early and late-phase clinical supplies for these next-generation conjugates. Explore specific examples of challenges encountered in process and analytical development, along with corresponding solutions showcasing robust development offerings and scientific expertise.