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CBS's analytical leadership and scientific team has a combined experience of more than 60 years in the analysis and characterization of biologics, with in-depth understanding of biologics chemistry and rich experience in developing suitable analytical techniques.



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Jason Tao, MS, RAC

Head of CBS

  

Biopharmaceutical leadership with over 25 years' experience in CMC regulatory strategy and authoring, CMC tech ops, analytical science, formulation development, technical transfer, GMP manufacturing and quality management. Therapeutic modalities include small molecules, monoclonal antibodies, and recombinant proteins.


Expert in utilizing regulatory guideline to provide risk-based, phase-appropriate, innovative CMC




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Chitrangada Acharya, Ph.D.

Group Lead, Bioactivity Assays

   

Over 15 years' experience, specialized in the entire portfolio of analytical development and qualification in cell and gene therapy, ranging from sterility testing, ligand or cell-based ELISAs, viral and non-viral gene modification, flow cytometric characterization to potency evaluation. Extensive mammalian cell culture experience with expertise in recombinant protein and antibody expression.





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Bharat Datla, MS

Group Lead, Structure Analysis

   

Over 10 years' experience, specialized in structure analysis of proteins by LC/MS and biophysical characterization by CD, DSC, DLS, fluorescence and various techniques. Experience in designing and performing formulation studies, forced degradation and stability studies, leading to several successful INDs and BLAs filings when working for Sanofi.




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Pradeep Pandey, Ph.D.

Group Lead, Product Purity Analysis

   

Over 13 years' experience, specialized in chromatography separation methods including IEX, SEC, HIC and RP and CE-SDS methods. Hand-on experience in protein isoform separation and identification. Designed and performed analytical, stability and comparability studies to support formulation and process development. Contributed significantly to the CMC section of several INDs and BLAs including KEYTRUDA® when working for Merck.



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China
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Suite 500-B, 3000 Eastpark Blvd, Cranbury, New Jersey 08512, USA
bd_global@crystalpharmatech.com +1-609-604-8303