Biopharmaceutical Characterization Services

Biopharmaceuticals are complex protein structures. Owing to their large structure and due to their production & purification from biological systems, they are prone to deviate from the desired product profile. These products require extensive characterization before they become approved therapeutics. For approval of biosimilars products, a comparability study that demonstrates the similarity of its structure, function and physicochemical properties with the original biologics is required.

Shantani provides a complete range of biopharmaceutical characterization services to support the development of novel Biologics & Biosimilars. Our aim is to support the regulatory requirements of biopharma developers by providing comprehensive comparability analysis based on the totality of the analytical evidences. Our networked operational model, access to high-end instruments and cutting-edge technologies help us provide high-quality data and analysis at rapid turnaround time. These services are categorized as:

 Biopharma Product Characterization

  • Analysis of Physico-Chemical Properties
  • Structure and Functional Characterization
  • Characterization of Product Linked Impurity/Modifications

 Biopharma Process Characterization

  • Cell-Line Characterization
  • Purification Linked Characterization
  • Host Cell Protein/DNA Impurities

Shantani’s Workflow 

Shantani’s consultation-characterization-collaboration business model spans across lab-to-regulators-to-market assuring best quality services to the collaborators. A team of dedicated, specialized protein scientists utilize their decades old expertise in analyzing data obtained from different techniques in making appropriate conclusions. A single point of contact is assigned for each study, who communicates with the client on a timely basis and make sure that all the requirements are met throughout the life of the project.