
SERVICES
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.