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Manufacturing

Intas’ manufacturing capabilities are aligned to a business strategy of developing and commercializing highest quality products across the glob. Intas’ has extensive capabilities to develop and manufacture Recombinant proteins, monoclonal antibodies, pegylated technology platform products and plasma derived products.

Microbial Fermentation & Mammalian Cell Culture Manufacturing Facilities

The company’s capabilities encompass small-scale to large-scale microbial fermentation, mammalian cell culture, protein & antibody purification, pegylation, lyophilization, aseptic formulation and fill-finish. With complete backward integration, the facility carries-out bulk-drug manufacturing and formulation fill-finish activity for pre-filled syringes, vials and pen-fill for devices. Intas’ International GMP compliant manufacturing facilities are supported by modern process development and quality control infrastructure. These facilities are accredited by the local and international regulatory agencies. The manufacturing facility has garnered European Union - Good Manufacturing Practice (EU-GMP) certification for Drug Substance and Drug Product.

Facility Highlights

  • Approx. 100,000 square feet of cGMP manufacturing space accommodates Class 100,000 suite for microbial fermentations
  • Multiple Class 10,000 stainless steel bioreactor suites for mammalian cell cultures
  • Class 10,000 complete disposable bioreactor suite for mammalian cell cultures
  • Multiple Class 10,000 purification suites for downstream processing
  • Class 100 suite each for filling into pre-filled syringes, vials and cartridges
  • Class 10,000 suite for pegylated products manufacturing
  • In-house facilities for visual inspection of finished goods, packaging, and dispatch
  • Cold rooms with continuous temperature monitoring for storage of bulk intermediates, semi-finished and finished products
  • Separate facilities housing automated stainless steel tanks for media and buffer preparation needs
  • Continuously monitored utility systems (water-for-injection, steam, chilled water, compressed air etc) to support process requirements
  • The facilities are designed to accommodate future capacity enhancement and are continuously monitored by facility monitoring and building management systems

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