Non Biologics Complex Drugs (NBCD) Testing Services

Non Biologics Complex Drugs Testing Services

Non-Biological Complex Drugs (NBCD) are neither biologics nor small molecules, rather a mixture of the two. These are synthetic compounds with complex structures and high molecular weights, 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), and Glatiramer Acetate (GA).

Challenges in Characterization

Owing to their complexity and specific composition mix, it is difficult to fully identify, characterize, quantify, or describe their physicochemical properties. This necessitates highly specialized analytical approaches to ensure the safety, identity, and potency of these complex synthetic mixtures throughout the development lifecycle.

Comprehensive NBCD Analytical Offerings

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, and CE: Utilizing advanced chromatography and electrophoresis for precise molecular fingerprinting. Assay and In Vitro activity: Quantifying the active components and measuring biological functionality in controlled environments. Impurity characterization: Utilizing Octet K2, HPLC or LCMS, RT-PCR, and Bioplex 200 to identify trace contaminants in complex matrices. In Vivo Immunogenicity: Assessing potential immune responses using ELISA to ensure patient safety. Equivalence in the fragment map: Detailed structural comparison to establish parity between different drug lots or formulations.