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Next Generation Biopharmaceutical Downstream Process

04 Sep 2018 - 04 Sep 2018 Past Event

Merck is hosting the Next Generation Biopharmaceutical Downstream Process Symposium at CPI, Darlington.

Event Details

Start Date:Tuesday, 4 September 2018 @ 09:00
End Date:Tuesday, 4 September 2018 @ 17:00
Address:Centre for Process Innovation, National Biologics Manufacturing Centre, 1 Union Square, Central Park, Darlington, DL1 1GL (Please use DL1 1GP for satnav)

Join us to learn more about the project objectives:

• Implement a fully integrated manufacturing platform based on continuous chromatography

• Learn single-use disposable techniques for all unit operations of DSP sequence for mAbs at pilot or small production scale

• Incorporate advanced analytical tools into your process

Presentation Topics

• Primary separation: substitution of the standard process for primary separation with the utilization of flocculants and Tangential Flow Filtration (TFF).

• Continuous capture step: integration of continuous chromatography in the capture step and development of novel disposable equipment for larger scale. Additionally non-chromatographic capture step alternatives, such as continuous precipitation.

• Disposable DSP: evaluation of single-use disposable solutions for flow-through polishing steps for efficient removal of impurities and single pass TFF (SPTFF) as continuous product concentration approach.

• Advanced analytical tools: different tools for measuring impurities, product content and other parameters in real time or close to real time.

  • 9.00:Registration
  • 9.30-9.50: Introduction and next generation strategies for manufacturing of biologics and project approach
  • 9.50-10.10: Utilization of flocculants for primary separation
  • 10.10-10.30: Continuous chromatography for capture step and development of novel disposable equipment
  • 10.30-11.00: Coffee Break and Networking
  • 11.00-11.20: Alternative batch Protein A chromatography, process modelling and alternative scenarios developments
  • 11.20-11.40: Continuous precipitation and precipitate harvest
  • 11.40-12.00: In-line virus inactivation
  • 12.00-13.00: Lunch and Networking
  • 13.00-13.40: In-line particle detection and IgG sensors
  • 13.40-14.00: Flow through approaches – MM approach and membrane adsorbers
  • 14.00-14.30: Coffee Break and Networking
  • 14.30-14.50: Single pass TFF (SPTFF) as continuous product concentration approach
  • 14.50-15.20: Large scale connected setup and outlook
  • 15.20-15.30: Workshop Closure and Feedback

The life science business of Merck operates as MilliporeSigma in the United States and Canada. Merck is a trademark of Merck KGaA, Darmstadt, Germany. All other trademarks are the property of their respective owners. Detailed information on trademarks is available via publicly accessible resources. © 2018 Merck KGaA, Darmstadt, Germany and/or its affiliates. All Rights Reserved.

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