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
