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BIOPHARMA

The new division, Biopharma has been setup in 2014. Our Scientific Team although new, has total experience of 15 years. VIMTA’s 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 has 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.

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 (Orthogonal approach)
  • Lot release assays
  • Process and Product related impurity testing
  • Stability testing
  • Bioassays
  • Extractables & Leachables
  • In vivo, In vitro potency testing
  • Monoclonal and Polyclonal anti-sera production
  • Sterility testing
  • Toxicology studies
  • In vitro bio-waiver 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)
  • Intact mass
  • Glycan profiling by MS
  • Saccharide mapping
  • LC-MS based Host Cell Protein determination
  • LC-MS and MS-MS approach for impurity characterization
  • Disulphide mapping
  • Lipid impurities (Lipid View)
  • 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 (HCD) 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 (HCD) 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)

Others:

  • 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)

Monoclonal Antibodies

Rituximab

Bevacizumab

Trastuzumab

Therapeutic Proteins

EPO, G-CSF, GM-CSF, IL-2

Insulin analogs, PTH, Exenatide

Other molecules

Heparin

Low Molecular Weight Heparin

Glatiramer Acetate

Sucralfate

Iron Sucrose

 

Bioassays

Technology Platforms

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