SERVICES

Biosimilar product development

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  • Set-up product development strategy

  • Explanation of regulatory expectations

  • Clone development/transfer

  • Process development

  • Process consistency 

  • Preclinical Toxicity

  • Scale-up

  • Product characterization

  • PC/PV

  • Clinical trials (phase-I & III)

  • Marketing Authorization

Novel Antibody development

(phage display platform)

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  • Development Strategy

  • Screening of target in display library for multiple panning

  • Identification of best binders in transient expression

  • Clone development (mammalian cell lines)

  • Selection and transfer of top 10-20 lead clones for the target 

  • Proof of concept

  • Process development 

  • Pathway identification

  • Process consistency 

  • Preclinical Toxicity

  • IND submission

  • Scale-up

  • Product characterization

  • PC/PV

  • Clinical trails (Phase-I, II & III)

  • Marketing Authorization

Analytical services

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Method development and qualification of complete product release and characterization methods for Biopharmaceuticals.

  • Biosimilar In-process to LRA assays

      o   Method Development and Qualification of LRA for Biologics             

  • Cell based assays

       o   Cytotoxicity assays (CDC, ADCC, ADCP)

       o   Cytostatic assays

       o   Cell proliferation assays

       o   Molecule induced cytokine release assays

       o   Cell based binding ELISA 

       o   Flow cytometry assays binding assays

  • SPR & BLI binding kinetic assays

       o   Estimation of molecule binding kinetics

       o   High/Low affinity lead identification 

       o   Binding potency assays

  • Capillary Electrophoresis – PA800+

       o   CE-SDS, CE-IEF & CZE

       o   Capillary electrophoresis in chiral separations.