DTA Consulting joined forces with Alphalyse to help a client improve their HPLC setup for GMP production of a peptide with high stability
DTA Consulting provides regulatory counselling to clients in the biotech and pharma industry. They assist from discovery through clinical development, as well as in commercial production. The company is founded and headed by M.Sc (Pharm) Dorrit Andersen, who has more than 30 years of experience in Regulatory Affairs, Clinical Research and Quality.
Perfection of the method and production of high-quality MS data
Dorrit Andersen established contact to Alphalyse since her client, a biotech firm, needed analytical support for clinical trials. It turned out that the HPLC method they used for stability studies and formulation optimization was not robust enough for GMP production, probably due to aggregation and precipitation problems.
The former HPLC method was optimized and made robust by our team. Only two months later, substantial data from MS, HPLC and SEC, and an overview of the stability of the peptide product, was available. This made it possible for the biotech firm to optimize their formulation and manufacturing process. All in due time before GMP production of the peptide.