Character Omics group at Enzene plays a unique role in linking structural attributes of products to functional impact throughout the product cycle starting from CMC developmentto PCS and CT studies.Our group has access to high end technologies that allows complete and comprehensive analysis of product attributes and process impurities, which is critical for the developmentof biosimilars.We also have expertise in developmentof PK and immunogenicity assays, which are key components of PCS and CT study designs.
- TOP-Down and bottom up peptide mass fingerprinting of proteins and monoclonal antibodies using state of the art LC-MS and LC-MS/MS techniques.
- Critical Quality Attribute assessment of biosimilars
- Comprehensive binding kinetics assessment studies using Octet platform
- Immunogenicity assessment for ADA and neutralizing antibodies
- Proteomics approach for identification and quantification of HCPs
- Clinical and Preclinical biosimilars testing services
- PK method development and validation for large proteins and mAbs
- Strategic approaches to PTM analysis using due diligence with robust enzymes coupled with high sensitive LC-MS
- Fingerprint analysis to enable USFDA and EMEA regulatory requirements using orthogonal approaches for biosimilarity assessment and metabolomics technologies to enable media optimization through spent media analysis.
We use latest equipment in our facility to achieve the high degree of accuracy and quality needed, supported by world class infrastructure, such as
- State of the art LC-MS: QTOF-MS,
- ELISA Platform.
- 2D-Gel Electrophoresis platform