Case study

Optimized analysis of peptides for clinical trials

Better HPLC method lead to stable GMP produced peptide product

DTA Consulting joined forces with Alphalyse

Helps a client improve their HPLC setup for GMP production of a peptide with high stability

DTA Consulting provides regulatory counseling 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 over 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 with 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, SEC, and HPLC analysis, and an overview of the stability of the peptide product, was available. It made it possible for the biotech firm to optimize its formulation and manufacturing process. All in due time before GMP production of the peptide.

Testimonial Alphalyse

‘The collaboration with Alphalyse was superb! They quickly presented an optimized method that provided excellent data and clearly separated product related impurities. The contribution made it possible to keep our milestones. In my opinion, Alphalyse has professional, dedicated and very experienced employees’

Dorrit Andersen, Regulatory Affairs Consultant, Owner

DTA Consulting, Denmark

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