Epygen Biotech

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CDMO PROFILE

Strong Scientific Lead

Lead Scientist

Post Doc - Thomas Jefferson University, USA. PhD in Mol. Bio. - IICB, Jadavpur Univ. Focuses on mammalian and microbial technology developments, Cloning and Protein Engineering.

Senior Scientist

PhD (Tech.), Anna University, M. Tech Biotech, Anna University, India. Expert in bioprocess engineering and protein purification. With Epygen since 2012 and played key role in technology transfers

Head - Regulatory

PhD Biopharmaceuticals, VIT, Vellore. M.Pharm. Ramachandra Med. Coll., India. Has international Biopharma experience and handles Epygen’s Global regulatory framework.

Chief Scientific Advisor

Scientist who invented India’s first bio-therapeutic drug and fourth gen molecule for Ischemic Stroke. PhD from IISC Bangalore and Post Doc from Univ. of California and Albert Einstein Coll. of Med., NY.

Capabilities and Capacities for CDMO services

Epygen offers an end-to-end Biological service from clone till vialing for intra/extra cellular therapeutic proteins. We are capable to scale up and manufacture sensitive proteins undergoing cell lysis, solubilisation, refolding and range of purification processes entailing chromatography and membrane separations

R&D and Analytical Development

  • Equipped with latest Molecular Biology, Protein Engineering and Bioprocess tools. In-house analytical, bioassay & stability analysis, meeting latest guidelines
  • Equipped with latest Molecular Biology, Protein Engineering and Bioprocess tools. In-house analytical, bioassay & stability analysis, meeting latest guidelines

Scale-Up and Manufacturing DS

  • Scale-up of Fermentation and Purification processes upto 150 L catering to pre-clinical, clinical and commercial requirements
  • Capable of handling PEGylation

Fill & Finish of DP

  • Aseptic filling & Packaging of Biologics in vials and in-house lyophilization capabilities
  • On-site Characterization, QC, Testing and release, Specialized Bologics storage.

Overall Biologics development snapshot:

  • Epygen can support and develop products and processes from Clone, Pre-clinical and Clinical, till commercial stages, abiding highest global standards
  • 1. Clone selection, Cloning and Clone QC, Cell Banking
  • 2. Analytical development & qualification
  • 3. Scaling up of Fermentation, optimization & development
  • 4. Scaling up of DSP - Lysis, Centrifugation, Ultra- Dia Filtration, TFF
  • 5. Large scale IEX, HIC, Affinity Chromatography, Endotoxin removal, Polishing
  • 6. Fill & Finish Formulation development of injectables & Stability studies (ICH compliant).
  • 7. Analytical method development and validation  
  • 8. cGMP Regulatory batches USP & DSP 20,50,100 Lt scales
  • 9. Pre-Clinical Studies / Complete Biological and Physicochemical Characterization
  • 10. Tech. transfer for commercial Mfg
  • 11. Process validation at Mfg. scale

State of the art Biopharmaceutical Manufacturing Unit

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