Biologics & Biosimilars

Potency Testing by ELISA and Bioassays

Immunogenicity Studies (IIRMI) and Cytokine Profiling (PBMC)

Antibody Titre for Vaccines

Serology Studies for Vaccines

Bioidentity Studies

Biowaiver Studies for Complex Generics

Mass Spec Analysis of Peptides and Proteins

Impurity Profiling and Excipient Analysis

Post Translational Modifications and Bioanalytical Studies

Comparative Assessment for Biosimilars and ANDA