Developing Stable Cell Lines with an Orthogonal Approach to Analytics
Sponsored by: Sartorius Stedim BioOutsource
- Cell Line Development
- Analytical Analysis
- Biological Therapeutics
Date: 30 November
Time: 3PM London/10AM New York
Improve speed to clinic and mitigate risk with appropriate analytical analysis
As developed countries face increasing health care costs and developing countries strive to provide affordable medicine, there is a strong global commitment to the development of biogeneric/biosimilar/biobetter therapeutics. Advancements in expression systems and improvements in production cell lines (exemplified by ever-increasing yields), are allowing bioprocessing companies to progress with smaller, scaled-down equipment in adaptable, multi-product facilities.
Speed to market is critical and to expedite development a greater network of global partnerships are becoming established: well-established companies, including those who manufacture originator and biosimilar products, are working with companies in developing countries to expand their markets and to access facilities for local manufacture of their product. However, producing biosimilars, in any region, is not a simple task as the complexity of a monoclonal antibody (mAb) means that an identical copy of the originator molecule is virtually impossible to achieve.
This case study presents our approach to developing a monoclonal cell line with the capability to express a mAb, and subsequent analysis of the product’s characteristics using methods which could be utilised to confirm critical quality attributes. The robust Cellca DG44 cell line platform has been used in over 50 cell line engineering programmes to produce stable monoclonal cell lines, which regularly express in excess of 3.0 g/L mAb in a fed batch manufacturing process which has proven to be scalable across many bioreactor formats.
Orthogonal methods were used to assess the structural, binding and functional properties of the mAb, thus providing a greater understanding of the ascribed characteristics. These processes and analytical packages can be combined to address the many challenges faced by biosimilar developers in the quest to streamline biosimilar process development using a data-driven, “right-first-time” approach.
By adopting a platform framework we demonstrate the benefits of including key analytical analysis throughout the development of a monoclonal antibody to significantly reduce the time to clinical batch including the preparation of master cell banks and full biological safety characterisation. Register today and learn how Cellca and BioOutsource can reduce your product development timelines.
Dr. Christoph Zehe,
Head of Technology Development & R&D Sartorius Stedim Cellca
Dr. Christoph Zehe holds a doctoral degree in molecular and cell biology from the University of Heidelberg (2007). In 2007, he joined Cellca GmbH and developed Cellca’s proprietary expression system. Furthermore, he established one of the most competitive platform processes for the generation of high-expressing production cell lines on the market. In 2014, Dr. Zehe was appointed as Head of Technology Development and is now in charge of all product development and improvement activities at Cellca.
Dr. Laura Munro,
Technical Services Scientist II
Laura joined BioOutsource as a scientist in 2014 after completing a PhD in Molecular Parasitology at Strathclyde Institute of Pharmacy and Biomedical Sciences at the University of Strathclyde. With experience in in vitro assays and in vivo research, Laura is well positioned within the Technical Services department at BioOutsource as an assay development scientist responsible for the development and qualification of cell-based and binding assays, for use in the Biosimilar analytical comparability.
Key Learning Objectives
- Utilising scale down models to demonstrate manufacturability of platform processes
- Benefits of a platform approach in understanding the complexities of cell line development
- Orthogonal analytical approach to demonstrate critical quality attributes
- Chief Scientific Officers
- Head of Research and Development
- Head of Biosimilars Product Development
- Head of Operations
- Head of Regulatory Affairs
- Project Managers
- Senior Scientists