Biologics


Biologics

Manufacturing

Drug substance & Drug Product facility inspected and approved by Qualified Person from EU prior to commencement of Phase I studies

Drug Substance

Location
  • Nerul, New Mumbai
Capabilities
  • Fully functional State-of-the-art GMP facility for Biotherapeutics
  • Capacity expansion to Commercial scale completed
  • Plant built to comply with current Good Manufacturing Practices (cGMP), EU and USFDA regulatory requirements.
  • Preparation of material for clinical studies, API Generation and Commercial scale manufacture
Infrastructure
  • Fully Automated Fermentors
  • Tangential flow filtration systems for micro, dia and ultra-filtration
  • Homogenisers
  • Continuous Centrifugal Separator
  • Protein Purification Systems (1ml/min to 3L/min flow rates)
  • HPLC/FTIR/UV- visible spectrophotometers
  • Stability chambers
  • Phase Contrast microscope, BET kinetic reader
  • PLC based Kill tanks Commercial scale cGMP facility expansion completed and has been designed for US FDA and EMEA regulatory compliance.

Drug Product

Location
  • Daman
Capabilities
  • Manufacture of Liquid vials, lyophilised vials, opthalmic bottles and prefilled syringes
  • Facility has been approved by WHO GMP and MHRA
  • Facility inspected by Canadian health authority, State FDA & CDSCO
  • Pre filled syringe facility installation completed





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