Webinar: Optimizing a Biosimilar Production Process

Sponsored by: Eppendorf

Focused on:

  • Biosimilar
  • Herceptin
  • C H O
  • Scale Up
  • S U B

Date: 14 June

467

Time: 3PM London/4PM Berlin/10AM New York

Evaluation of batch, fed-batch, and perfusion methods for cell culture scale-up

The global market for biosimilars is expected to reach US$25 bn by 2020, when more than ten global blockbuster biopharmaceuticals, with sales of more than US$67 bn, will be off-patent. Many of these drugs are human or humanized monoclonal antibodies (hMAbs).

In this webinar, we present and discuss experimental results from collaboration with TPG Biologics, Inc. The company has developed a suspension Chinese hamster ovary (CHO) cell line that expresses an hMAb which is a potential biosimilar to trastuzumab (Herceptin®), used to treat breast, stomach, and esophageal cancer.

The objective of this research project was to determine if the three primary methods of production for a typical biosimilar (batch, fed-batch, and perfusion) may be simply and easily executed using a single, benchtop bioprocess control system to allow confident process decisions that are scalable to full production. We compared two perfusion processes. In one setup, cells were retained in the bioreactor using the ATF™ System (Refine Technology), a hollow fiber filtration device. In the second setup, cells were cultivated in a packed-bed bioreactor in which cells were immobilized in or between Fibra-Cel® discs. For the fed-batch and perfusion cultivations, we used stirred-tank single-use bioreactors.

This webinar will discuss the outcome of these studies, and will provide an analysis of the benefits of their respective usage in biosimilar production with a particular focus on improving time and cost efficiency.

Join Dr. Stacey Willard, as she shares insights on cell culture process development and production of hMAbs.

Presented by

Stacey Willard, PhD,

Senior Research Scientist

Dr. Stacey Willard earned her PhD from the University of Virginia. Ever since, her research was focused on biopharmaceutical development. Stacey has almost 20 years of experience in drug development and held positions in academic institutions (Johns Hopkins School of Medicine, the Roswell Park Cancer Institute) and within the biopharmaceutical industry. Since 2013, Stacey has been a Senior Research Scientist at Eppendorf, Inc.

Key Learning Objectives

  • Learn about the basics of cell culture process development
  • Understand the challenges and benefits of establishing a perfusion process in biopharmaceutical process development
  • Compare different cultivation methods regarding cell yields, product titre and possibility to scale up
  • Get the chance to receive first-hand insights and ask questions during the Q&A session

Audience

  • Professor
  • Assistant Professor
  • Head Of Research
  • Head Of Process Development
  • Laboratory Director
  • Laboratory Manager
  • Laboratory Supervisor
  • Team Leader Engineering
  • Senior Engineer
  • Principal Engineer
  • Process Engineer
  • Project Manager
  • Post Doc
  • Research Scientist
  • Research Engineer
  • Principal Investigator
  • Senior Investigator
  • Senior Scientist
  • Scientist
  • Researcher
  • Operations Manager