Biopharma product development is a multi-step process. During process development, characterization of the product at each step can help in improving and ensuring that a high-quality product is consistently manufactured. Defining critical quality attributes for the complex biological molecule is difficult, however, analysis of hysicochemical properties and linked structural & functional characterization can directly define the quality of the product. Many regulatory agencies also suggest that before seeking approval, product-linked impurity and modifications should also be assessed thoroughly. The complex nature of biopharma products necessitates that a multidisciplinary approach is adopted for their in-depth characterization. With a clear understanding of the product development cycle and regulatory pathways for marketing approval of protein-based products, Shantani integrates modern spectroscopy and spectrometry-based methods to help customers achieve their product development goals.
We strongly believe and have demonstrated that manufacturing processes that adopt Physico-chemical characterization of products early in their development plan reach the goal faster. The requirement of a physico-chemical characterization dataset by regulators is merely a retrospective look of a product developed through a qualified process. For maximizing probability of fast development and marketing approval of your biopharma product, we provide our extensive experience in the form of consultancy.
Shantani provides a wide range of biopharmaceutical characterization services to support the development of novel Biologics & Biosimilars at all levels. Our aim is to support the regulatory requirements of biopharma developers by providing a comprehensive comparability analysis based on the totality of the analytical evidence.
Shantani is given authority to generate the complete data package for biosimilarity assessment between the test and reference products. Every test result and deviation are analyzed in detail. A comprehensive Technical Report that assesses the biosimilarity by capturing and using the totality of analytical evidence, is provided as a final deliverable.
The Client and Shantani agree on a method qualification/validation + Sample analysis plan. The analysis is carried out within the criteria of the developed method. As deliverables, ‘Method Qualification/Validation Report’ & ‘Test results with basic interpretation’ is provided; however, an assessment of bio-similarity is carried out by the client.
The analysis is carried out using the already developed methods and techniques at Shantani, and the ‘Test results’ are provided as deliverables to the client. Interpretation of the results and assessment of bio-similarity is left to the client.
As protein analysis experts, we utilize the power of Mass-Spectrometry and Spectroscopy in delivering several protein-analysis-linked solutions to life-science researchers globally. We work closely with our clients and assist them in analyzing the problems, designing the experiments, and then carrying out the experiment according to mutually agreed technical scope.
