Non-Biological Complex Drugs (NBCD) are neither biologics nor small molecules, rather a mixture of the two. These are synthetic compounds with complex structure and high molecular weight, and can form branched structures such as polypeptides, swelling polymers, liposomes and colloidal iron carbohydrates. A few prominent examples of NBCD include Iron Sucrose, low molecular weight heparin (LMWH), Glatiramer Acetate (GA) etc.

Owing to their complexity and specific composition mix; it is difficult to fully identify, characterize, quantify or describe their physicochemical properties.

VIMTA offers US-FDA and EMEA guidance based analytical characterization as well as potency estimation (Lot Release Assay) services for testing of NBCD. Our test offerings include:

• Identification using RP-HPLC, SAX-HPLC, CE
• Assay
• In Vitro  activity
• Impurity characterization using Octet K2, HPLC or LCMS, RT-PCR, Bioplex 200
• In Vivo  Immunogenicity using ELISA
• Equivalence in the fragment map