Product/Service

API Production Under GMP

Source: Rentschler Biotechnologie GmbH

API Production Under GMP
All aspects of biotechnological production of active pharmaceutical ingredients (APIs) derived from mammalian cells are available at Rentschler Biotechnologie, from basic services for development and production, to process development in cooperation with clients, and validated routine GMP production

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Datasheet: API Production Under GMP

All aspects of biotechnological production of active pharmaceutical ingredients (APIs) derived from mammalian cells are available at Rentschler Biotechnologie, from basic services for development and production, to process development in cooperation with clients, and validated routine GMP production.

The GMP certified production of APIs at Rentschler Biotechnologie is done in state-of the-art facilities. Eight separate GMP suites for Upstream Processing (USP) and Downstream Processing (DSP) currently covering a total area of over 6,000 m2 (64,000 sq. ft.) are available for client projects.

Rentschler offers:

  • Production for Phases I-III clinical trials in accordance with GMP guidelines
  • GMP production for the market
  • Stirred tank bioreactors:
    • 30 / 50 / 250 / 500 and 2,500 L
  • Multitray technology:
    • Daily harvests up to 1,000 L
  • Trusted preferred partnership agreement with Boehringer Ingelheim for a seamless project transfer to large-scale manufacturing of up to 15,000 L
  • Cultivation methods:
    • Batch, repeated batch, fed batch
    • Continuous processes (e.g. perfusion)

Click Here To Download:
Datasheet: API Production Under GMP