BIOPHARMA SERVICES

VIMTA is a leading service provider in India offering extensive structural and functional analysis for Biological molecules.

We offer comprehensive services including:
    • ✓ Product Characterization (protein characterization, with orthogonal approach as well)
    • ✓ Lot release testing
    • ✓ Process and Product related impurity testing
    • ✓ Stability testing.
    • ✓ Biosimilar testing
    • ✓ Bioassays
    • ✓ Extractables & Leachables
    • ✓ Invivo biosafety
    • ✓ In vivo and In vitro potency testing
    • ✓ Monoclonal and polyclonal antisera productions
    • ✓ Sterility testing
    • ✓ Toxicology studies
    • ✓ In vitro biowaiver studies
    • ✓ Data analysis for biomolecules using integrated software technologies

Our cGMP compliant laboratory is equipped with state of the art technologies such as LC-MS 5600+, HPLCs, ABI-Sequencing platform, q-PCR, MALDI-TOF, Bioplex 200 and Multimode plate reader etc.

Our scientific team, with over 15 years experience, have the expertise to characterize biosimilar products such as recombinant proteins and peptides, monoclonal antibodies or nucleic acid-based drugs and can help you to design and conduct safety and efficacy studies.

Identity tests:
    • ✓ SDS-PAGE for molecular weight determination
    • ✓ Western blot for specificity
    • ✓ IEF (strip based) for pI confirmation and Isoform distribution
    • ✓ Digest mapping (peptide mapping for proteins) by HPLC.
    • ✓ Intact mass (MALDI TOF)
    • ✓ Glycan profiling by HPLC
    • ✓ Binding assay for Antigen- Antibody interaction studies
    • ✓ Charge variant analysis
Activity:
    • ✓ In vitro Functional Bioassay
    • ✓ In vitro Binding assay (early stage assays)
    • ✓ Neutralizing antibody assays
    • ✓ Potency calculation using PLA 3.0 statistical software
    • ✓ Virus titer determination by TCID50
    • ✓ Antiviral bioassays and CPER (Cytopathic effect reduction) assays
LC-MS :
    • ✓ Sequence determination by MS-MS (Protein pilot software)
    • ✓ Intact mass
    • ✓ Glycan profiling by MS
    • ✓ Saccharide mapping
    • ✓ LC-MS based HCP determination
    • ✓ LC-MS and MS-MS approach for impurity characterization
    • ✓ Disulphide mapping
    • ✓Antibody drug conjugate analysis
Assay :
    • ✓ RP-HPLC for Identification and purity
    • ✓ RP-HPLC & Biochemical methods for Quantification
    • ✓ ELISA for quantification
    • ✓ Multiplex assays
    • ✓ Impurities
    • ✓ Host cell DNA and Host cell protein (HCP) for process related impurities
    • ✓ Size exclusion (SEC-HPLC) for LMW and HMW (product related impurities)
    • ✓ RP-HPLC for protein modifications (oxidation or methylation of protein)
Impurities :
    • ✓ Host cell DNA and Host cell protein (HCP) for process related impurities
    • ✓ Size exclusion (SEC-HPLC) for LMW and HMW (product related impurities)
    • ✓ RP-HPLC for protein modifications (oxidation or methylation of protein)
Miscellaneous:
    • ✓ Characterization of Low Molecular Weight Heparin as per US-FDA and EMEA guidelines
    • ✓ Characterization of Glatiramer Acetate as per US-FDA guidance
    • ✓ Bio-analytical services (PK/PD)
    • ✓ Method development (as per ICH Q6 B)
    • ✓ Method verification (IP, EP, BP and USP) or
    • ✓ Technology transfer methods
    • ✓ Method validation (as per ICH Q2R1)
    • ✓ Regulatory documentation for submissions
    • ✓ Immunogenicity assessment