Biosimilars are complex protein structures, that  are difficult to characterize.  Variations can occur in the nature of biosimilars even under stringent GMP conditions, which in turn affect both efficacy and tolerability.
Sipra Labs is equipped to meet the specific testing requirements of biosimilar products. Analytical, Bio-analytical, Pharmacological/ toxicological and clinical trials required to prove their biological similarity are conducted at Sipra. These experiments are carried out with definite time lines.

•   Identification of recombinant proteins as per USP
    (SDS-page, Western blot, Peptide mapping)
•   Analysis of protein impurities in recombinant
    preparations
•   Gene quantification by RT-PCR
•   Molecular size determination (SEC)
•   Clinical biochemistry analysis
•   Heparin ,Enoxaparin, Human Serum Albumin
    analysis

•   Biological Activity ( IIa and Xa of Chapter <851> USP )
•   Pyrogen Testing (Chapter <151> USP )
•   Bacterial Endotoxins (Chapter <85> USP)
•   Sterility Testing (Chapter <71> USP)
•   Method Validation as per ICH
•   AMES Test as per OECD 471
•   Preservative Efficacy Test (Chapter<51> USP)
•   Biological Reactivity for Packing Material as per
    (Chapter<87>,<88> USP)