Case Study 1 - Analytical Development
Customer Need:
A mid-sized biotechnology company had to meet a demanding timeline to establish additional analytical methods as their product proceeded through clinical testing. With analytical resources stretched across several different projects, it was decided that the lead monoclonal antibody product required some additional structural characterization studies and an improved stability-indicating assay.
Formatech Plan:
Working with the company, Formatech scientists familiar with therapeutic monoclonal antibody products, designed a study that included abbreviated Stability FingerPrinting™ studies and the development of a non-native Size exclusion chromatography method as to a tool to examine aggregation.
An assay using Right Angle Light Scattering (RALS) to follow solution turbidity was implemented while concurrent Native and Non-native SEC was run to understand the product’s aggregation behavior under accelerated stress conditions.
Solution:
The additional information gained from this systematic examination of aggregation behavior lead to a new stability indicating assay and a minor change in the formulation prior to Phase III studies.
Formatech
WE FORMULATE SOLUTIONS
