Advinus provides R&D services for the discovery and development of compounds for diverse industries. It is an OECD GLP-accredited test facility, involved in conducting studies for global regulatory submissions. Advinus is committed to provide quality testing services meeting the expectations of customers and regulatory agencies by adopting Quality Management Systems of GLP and ISO/IEC 17025:2005
Biologic Biosimilar Offerings
Biologic/ Biosimilar Offerings

Advinus has successfully completed over 30 GLP regulatory toxicology studies of Biologicals. We now have the capabilities to perform PK and immunogenicity analysis to support our customers for their regulatory filings world-wide.

Our complete support portfolio for bioanalysis of biological and biosimilar molecules include following services:

In Vivo Assays

  • In vivo assessment of Pharmacokinetic and Pharmacodynamic parameters for Biosimilar and comparison with the Innovator Reference Product
  • In vivo Immunogenicity assessment for Biosimilar and the Innovator Reference Product by Multi-tiered Approach
    • Anti-drug Antibody Screening Assay
    • Confirmatory Assay
    • Titer Estimation
    • Neutralizing Antibody Assay by ELISA or Cell based Assays
  • Bioanalysis for Established Biomarkers

Assay Platforms for Biologics Testing

  • Sandwich ELISA
  • Bridging ELISA
  • Direct/Indirect ELISA
  • Competition ELISA

Toxicology Testing (GLP)

  • Maximum Tolerated Dose (MTD) followed by 10 day repeat Dose Range Finding (DRF) in rats
  • Repeat dose toxicity study in rats. Duration of the study may vary depending upon the biosimilar
  • Full assessment of Toxicokinetics/PK and Immunogenicity

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Advinus Therapeutics Ltd.
#21 & #22 Phase II, Peenya Industrial Area
Bangalore 560058, India
Phone: +91-80-28394959 | +91-80-66552700
E-Mail: |

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