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Biopharmaceutical

Biopharmaceutical Services

Mavens are dedicated to providing biopharmaceutical services for characterization and bioanalytical testing in support of preclinical and clinical development of biologics, biosimilars, peptides, protein drugs, vaccines, and other novel biologics drug products.

Bioanalytical Assay Development & Validation Services
  • Pharmacokinetics & toxicokinetics Profiling
  • Immunogenicity analysis for binding & neutralizing antidrug antibodies for therapeutic proteins & vaccines
  • Pharmacodynamics
  • Biomarker analysis
  • Receptor binding
    Measuring the intracellular activities, ADCC & CDC assays
Biosimilarity Testing Services for Drug Products
  • LCMS based analysis
  • Purity & contaminant levels
  • Comparative binding with receptor & with antibodies
  • Functional similarity using in vitro & in vivo models
OECD GLP Certified & GCLP Compliant Laboratory Testing Services
  • Preclinical toxicology
  • Method development, validation & study sample analysis services for PK, PD, Biomarker & ADA assessment
  • Assays validated as per US FDA, EMA & other regulatory guidance using 21 cfr compliance data acquisition instructions
In vitro Bioassays Services
  • Assay for potency evaluation
  • Functional assessment
  • Receptor binding
  • Measuring intracellular events
  • Neutralizing antibody detection
Biochemical Characterization Services
  • Intact mass & reduced mass analysis
  • Peptide sequencing and N and C terminal
  • sequencing
  • Disulphide bond location
  • Biosimilarity demonstration
  • Glycan analysis
  • Amino acid analysis
Physiochemical Integrity Analytical Services
  • Preclinical toxicology
  • Concentration analysis
  • Purity levels
  • Aggregate analysis
  • Contaminant metals
Impurity Analysis Services
  • Detection & quantification of host cell DNA by RT PCR
  • Detection & quantification of host cell protein by ELISA
  • Development & validation of methods detection HCD & HCP
Cell Banking & Other Services
  • Preparation of the master cell bank
  • Preparation of the working cell bank
  • Cell viability analysis
  • Mycoplasma testing
Antibody Generation & Purification Services
  • Polyclonal antibody generation in Mice, Rat, Rabbits, Guinea pigs & in goats
  • Affinity purification of antisera
  • Monoclonal antibody generation by hybridoma
  • Cascade immunization and null cell protein specific antibody production
    Ligand binding assay development & validation
Critical Reagents Preparation Services
  • Purified polyclonal & monoclonal antibodies
  • Biotin / HRP labeled drug products
  • Biotin / HRP labeled antibodies