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ECA - Continuous Bioprocessing

 

Continuous Bioprocessing (24 March 2020)

Objectives

This conference provides an overview of the concepts of continuous
processing and its level of adoption in the biopharmaceutical industry. Besides technological challenges, GMP questions related to continuous processing will be discussed.

Background

Continuous processing could be to be the next step for process intensification in the evolution of biopharmaceuticals. The biopharmaceutical industry is facing several challenges due to an increasing number of biosimilars and multiple therapies targeting the same indication which increases the costs but also reduces the required batch sizes. In addition, the expression levels for monoclonal antibodies could be increased by one order of magnitude which shifts the bottleneck further downstream, requiring an intensified operation in downstream processing.

Today’s standard batch manufacturing is comprised of a cascade of processes where the product is routed through one unit operation at a time and is collected in hold containers in between. This can limit both facility utilization and productivity.

Integrated processing on the other hand includes the use of continuous unit operations where product moves through a series of unit operations without interruption. This design allows reducing the size of unit operations which translates into buffer, resin and consumable savings. Further advantages of continuous manufacturing are seen in unprecedented control over product quality, better agility and flexibility as well as reduced risks of scale-up through smaller equipment and facilities.

Several pharmaceutical companies have shown successful examples for both fully integrated and hybrid processing platforms and first steps towards regulatory approval have been taken. However, the decision for continuous processing has to be made on a case-to-case basis. It is recommended to perform risk assessments for the platform, the connections and the automation to meet the GMP requirements.

Moderator

Prof. Dr. Regine Eibl, Zürcher University of Applied Science

Target Audience

This conference is directed at executives from development, engineering, production and QA responsible for the implementation of continuous biomanufacturing.

 

Programme

CONGRESS KEYNOTE

Annex 1 Revision – the long and winding road
Dr. Bernd Renger, Immediate Past Chair, European Qualified Person AssociationThe drivers of change

  • New paradigms and concepts
  • Contamination Control und Quality Risk Management
  • Stakeholder consultation
  • New expectations to Media Fills and Lyophilisation
  • The big challenges – CCIT and PUPSIT

 

Technological overview: Single-use technologies for intensified and continuous bioprocesses (USP & DSP)
Prof. Dr. Regine Eibl, Zürcher University of Applied Science

  • Continuous USP
    • High cell density and large volume cell banks
    • N-1 perfusion
    • Production in perfusion mode
    • Clarification
  • Continuous DSP
    • Bind-elute chromatography
    • Virus inactivation
    • Flow-through chromatography
    • Virus filtration

LIVE DEMOS
In the practical part of the conference, suppliers will show you different components and solutions. You will come in contact with the equipment and you have the chance to discuss your questions immediately with technology experts.

Intensified Downstream Processing with multi-column Chromatography
Pall Biotech

Continuous Biomanufacturing - a GMP inspector's view
Dr. Daniel Müller, Local GMP Authority of Baden-Württemberg

  • Regulatory guidance
  • General requirements
  • Application of single-use systems
  • Control - & validation strategy
  • Challenges and discussion points

Case Study Biosana: Continuous Manufacturing of bio-similar antibodies: a small company’s journey to phase 1 clinical studies
Maarten Pennings, BiosanaPharma

In 2018 the first clinical study was performed with a Mab that was manufactured with a continuous process from bioreactor to bulk drug substance. In this talk an overview of the purification process, a number of design aspects, automation control and virus safety will be presented.

  • Conversion to a fully continuous manufacturing process and run for weeks under GMP to produce Clinical Trial Material
  • Design choices in the frequency of exchanging single use components impact manufacturability
  • Challenges in downscaling to an appropriate model for viral clearance validation were addressed

Case Study Henlius (Shanghai): Development of an integrated continuous downstream process for a monoclonal antibody production
Dr. Heidi Gong, Henlius

In this presentation a bench-scale fully integrated continuous downstream process for monoclonal antibody production will be shown as well as its successful scale-up to 200 L. The process includes a continuous protein A step, a viral inactivation step, a batch-wise cation exchange and anion exchange step, a batch-wise viral-filtration step, and a single-pass UF/DF step.

Case Study Bayer: Continuous Downstream Processing for manufacturing of protein therapeutics
Dr. Felix Oehme, Bayer

  • Challenges and benefits of continuous manufacturing for biologics
  • Case study: Comparison of process parameters and product quality in batch and continuous manufacturing
  • Control strategy and regulatory aspects