Biosimilar product development

• 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)

• 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

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.