Chemical and Analytical Strategies for Biosimilars

\ \\  

\

\ \\

\

\ \\

\

\  

\

\ <p justify;\\\\"="" style="text-align: justify;">Management of cGMP facility calls for a strict monitoring all factors including analytical strategies, formulation procedures, packaging etc. For biologic products establishing comparability and interchangeability is a big hurdle. For this purpose employment of suitable analytical approach, bioassay, protein analysis, potency testing, safety assurances are highly important. LC/MS analysis for biologic products, characterization of Biologics, peptide mapping, Isoelectric Focusing and Capillary Isoelectric Focusing, SDS-PAGE, Thermal Analysis, Particulate Matter Analysis, Thermogravimetric Analysis are some methods commonly used for analysis of Biologics and Biosimilars products. On average, facilities outsource 32% of their analytical testing/bioassays (up from 28%) meaning that close to one-third of analytical testing is estimated to be outsourced by the industry. While small changes in these parameters can impact the various chemical permutations for a given biotherapeutic, innovators can, under certain circumstances, change the host cell, fermentation process, purification process, and even manufacturing site, but the product can be validated without undertaking a complete new product development review.

\

\ \\

\
  • Biosimilars multimodal techniques
  • Biosimilars bioanalytical methods

Related Conference of Chemical and Analytical Strategies for Biosimilars

February 28-March 01, 2019 ANA Crowne Plaza |

Global Pharmaceutical and Pharma Industry Conference

Osaka, Japan
March 18-19, 2019

13th International Conference on Biosimilars and Biologics

Amsterdam | Netherlands
July 26-27, 2019

13th Asian Biologics and Biosimilars Congress

Mercure Albert Park | Melbourne, Australia

Chemical and Analytical Strategies for Biosimilars Conference Speakers

Recommended Sessions

Related Journals

Are you interested in