Specialists in the Bioanalysis of Biologics 

Eurofins Advinus offers a range of prequalified methods to support the preclinical and clinical evaluation of biologics/biosimilars, including analysis and comparability testing, for exploratory and regulatory studies. We also provide bioanalytical services for monoclonal antibodies, novel peptides, fusion proteins and vaccines.

The following services are currently offered to support your development program for Biologics

  • Development of methods using multiple platforms such as LC-MS and ELISA
  • Experience in development of Bioanalysis and Immunogenicity methods
  • Expertise to handle tissue matrix from rodents, non-rodents, non-human primates and human samples
  • Sample processing using various techniques - precipitation, liquid-liquid extraction and solid-phase extraction – depending on the nature of the molecule
  • Smooth & efficient transfer of methods developed by the sponsor or reverse transfer to the sponsor
Bioanalytical (PK/TK) Capabilities 
  • Generation of critical reagents for novel biologics
  • Accurate and selective assays with high sensitivity and good dynamic range
  • Demonstration of bioanalytical similarity for biosimilars
  • Demonstration of dilution linearity and parallelism
Anti-Drug Antibody Capabilities 
  • Polyclonal ADA generation
  • Purification
    • Protein A/G and Antigen specific
  • Labelling
    • HRP, AP, Biotin 
  • ADA applications
    • Positive control for immunogenicity assay 
    • Capture/Detection reagent for PK assay
Neutralizing Antibody Capabilities       
  • Development of methods based on the mechanism of action of the drug
  • Experience in cell-based assays, enzymatic assays, ligand binding assays to demonstrate neutralizing potential of anti-drug antibody
Vaccine and Gene Therapy Products
  • Development of titer assays to assess antibody response to specific antigens
  • Optimization of kit-based methods to analyze total antibody response
Connect with us
Our mailing address is:
#21 & 22 Phase II, Peenya Industrial Area 
Bangalore 560058, India 

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