ATMP analytics

Advanced therapy medicinal products are a group of therapies and molecular entities which require a wide range of analytical techniques to describe their quality and efficacy. Although ATMPs, especially oligonucleotides, LNP encapsulated DNA/mRNA and viral vector-based products, are very different from proteins, they rely on very similar analytical techniques. With our 20+ years of experience in protein-based therapeutics, we were able to use our expertise to develop methods to describe the quantity, purity and impurities (e.g., IP-RP-HPLC, Capillary Electrophoreses, qPCR, ELISA), potency in regard to transfection/infection efficiency (cell-based assays) as well as the determination and characterization of particle sizes (e.g., DLS, SEC-MALS). Furthermore, we have experience with HPLC-CAD based methods for the determination of the purity and composition of lipids in complex LNP formulations. For ATMPs A&M STABTEST is the partner of choice no matter the type of formulation and delivery from liquids for injection to nasal or orally inhaled products.