Tech Transfer & Scale Up

Smooth tech transfers and scale-ups are critical success factors for the development of a biopharmaceutical drug. Careful planning and management of a tech transfer is essential to ensure that knowledge and experience gained during process development and/or early clinical manufacturing is effectively transferred. For decades Boehringer Ingelheim has developed its expertise in successfully transferring customers' small-scale processes into large-scale production. All relevant technologies are established and are being continuously improved. Boehringer Ingelheim BioXcellence™ offers highly flexible process formats for fermentation and downstream processing.

 

Fermentation of cell culture in GMP areas:

  • Production scale ranges from 80 L, 400 L to 15,000 L (stainless steel)
  • 500 L Single Use Bioreactors
  • Fed-batch as core technology / perfusion up to 2,000 L scale Feed-mode (bolus; continuous)
  • Harvest-technologies (Tangential-Flow-Filtration (TFF); Centrifugation)
  • Inoculum (spinner, shaker, WAVE™)

 

Downstream & Formulation:

  • All state-of-the-art chromatography and TFF techniques and matrices established
  • All relevant virus removal and inactivation techniques established (nano-filtration, heat (micro wave), pH treatment)
  • Gradient elution and inline dilution
  • Variety of bulk containers and freeze and thaw technologies established
  • Separate formulation suites and column packing area

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