Downstream Processing of Biologics
Downstream Processing of Biologics

Course Description

This 3-day course describes how to develop downstream processes for biologicals. From the use of individual unit operation to developing economical, robust and scalable processes. State of the art techniques with a risk-based approach and using a Quality by Design methodology are discussed. The topic of comparability in scale up and for biosimilars are discussed. Several case studies, describing the development of downstream processes of biologics, are presented.

  • Chromatographic and filtration unit operations and
    techniques used for biologics
  • Quality by Design (QbD) in process development
  • Risk-based design for downstream process design
  • Downstream process development, e.g. how to design the downstream process
  • Considering process economics for achieving a viable and competitive process
  • Scale up of your biologics process
  • The importance of comparability for biosimilars and scale up of biologics
  • Case studies; discussion of downstream processes of three different biologics
  • Understand individual unit operations used in downstream of biologics
  • Understand process development and design
  • Identify critical issues in designing a downstream process for biologics
  • Learn how to build your downstream process, combining techniques for a viable process
  • Apply QbD principles in process development
  • Understand risk-based process design
  • Understand how to maximize process performance through optimization
  • Developing an economical, robust and scalable process

Downstream Processing of Biologics

24 - 26 June 2024, Live Online Training
Regular price €1.850,00
Unit price
per 
Kjell Eriksson

Owner and senior consultant of RnK Biotech Consulting and Gozo Biotech Consulting with 35 years’ experience in the biotech field from academia and industry.

START TIMES

9:00 AM Vienna time

8:00 AM London time

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Course Description

This 3-day course describes how to develop downstream processes for biologicals. From the use of individual unit operation to developing economical, robust and scalable processes. State of the art techniques with a risk-based approach and using a Quality by Design methodology are discussed. The topic of comparability in scale up and for biosimilars are discussed. Several case studies, describing the development of downstream processes of biologics, are presented.

  • Chromatographic and filtration unit operations and
    techniques used for biologics
  • Quality by Design (QbD) in process development
  • Risk-based design for downstream process design
  • Downstream process development, e.g. how to design the downstream process
  • Considering process economics for achieving a viable and competitive process
  • Scale up of your biologics process
  • The importance of comparability for biosimilars and scale up of biologics
  • Case studies; discussion of downstream processes of three different biologics
  • Understand individual unit operations used in downstream of biologics
  • Understand process development and design
  • Identify critical issues in designing a downstream process for biologics
  • Learn how to build your downstream process, combining techniques for a viable process
  • Apply QbD principles in process development
  • Understand risk-based process design
  • Understand how to maximize process performance through optimization
  • Developing an economical, robust and scalable process

"Trainer is very competent and has the complete knowledge of the matter."

– Senior Process Expert, B. Braun

"It is not at all frequent to find this grade of preparation and reaction to specific cases such as the ones presented. I'm enthusiastic! Thanks really."

– Tech Transfer Lead, Novartis

"Thank you for sharing all the links and informative material. Very professional organization and execution."

– Manufacturing Manager, Thermo Fisher Scientific

"The trainer was very knowledgeable about the topics and was able to answer all questions."

– Drug Product Subject Matter Expert, Pfizer

"Excellent work of the lecturer, good materials, clear explanations."

– Clinical Pharmacologist, Boehringer Ingelheim

Downstream Processing of Biologics

Download the full training agenda to reveal complete session details, training takeaways, case studies, daily schedule, special features and full trainer bio.

Medical-Devices-Certificate-Course

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