Regulatory approval of biosimilars depends on the quality and comprehensiveness of the data generated through the comparative analytical, in-vivo and clinical studies....
The demonstration of analytical, pharmacokinetic and therapeutic equivalency of a biosimilar with its reference product is essential for its regulatory approval. ...
The development of vaccines has an immense impact on the overall world health condition. Consistent global efforts are being made to develop safe, effective and affordable vaccines....
Biologics are complex macromolecular recombinant protein drugs that are manufactured via genetically modified living cells. ...
Shantani is a one-stop destination for high-quality biopharmaceutical characterization services....
Shantani is proudly supporting the development of COVID-19 vaccines of multiple manufacturers through its Proteome Analytics expertise. ...
Shantani is proudly supporting the development of COVID-19 vaccines of multiple manufacturers through its Proteome Analytics expertise. Analytical characterization of vaccines is very important in ensuring the quality of the product. Our team has worked unremittingly to provide high quality characterization data to support vaccine’s regulatory data submission in expedited timelines.
Showcase example: The primary structure of the Receptor Binding Domain (RBD) of SARS-Cov-2 was analyzed by multienzyme digestion of protein followed by LC-MS/MS analysis.
