Cell Based Assays: Development and Validation

Why Should You Attend:

This course will cover various aspects of using eukaryotic cell culture as an assay system. The examples illustrated of the types of assays of a sample in a cell based assay will include the effect on proliferation, differentiated function and toxicity.

Cell based assays are being used by the pharmaceutical industry for high throughput screening of potential drug candidates. In vitro assays with eukaryotic cells are being used by the medical device industry for lot release testing of their products. Cell based assays have the advantage over animal based assays in that the former are lower cost and require less time to complete. With these advantages, cell based assays are appropriate as the first level of testing before testing in animals.

In addition, the opinion exists that there needs to be a reduction in animal biomedical testing and in vitro cell based assay systems are one way to achieve this. Attendees will leave the course understanding how eukaryotic cells are used as an assay system. At the conclusion of this webinar, attendees will have the knowledge of the applicability, development and validation of cell based assay systems.

Learning Objectives:

• Description of how cell cultures are used for in vitro assays.
• Examples of cell based assay systems.
• Advantages of cell based assays.
• The parameters to be optimized in the development of a cell based assay system.
• The steps in validating of a cell based assay.

Areas Covered in the Webinar:

• Background and introduction
• Development and optimization of a cell based assay
• Validation of a cell based assay

Who Will Benefit:

This webinar will benefit those in the pharmaceutical, biotechnology and medical device industries that are considering using eukaryotic cell culture for the assay of toxicity, proliferation or differentiated (specialized) function:

• Research and development managers, supervisors and technicians
• Manufacturing managers, supervisors and technicians
• Quality control managers, supervisors and technicians
• Senior management

Michael Simonian
Biotechnology Consultant, MHS Biotech Consulting

Michael Simonian, Ph.D., has over 30 years of experience in both basic research in academia and industry product development. Dr. Simonian is owner of MHS Biotechnology Consulting, which is a company that provides consultation and on-site laboratory services to medical device, pharmaceutical and biotechnology companies that range from start-ups to established multinational companies.

Dr. Simonian’s experience in industry includes application and product development for scientific instrumentation and research and development for in vitro diagnostic kits for infectious diseases. His experiences with scientific instrumentation includes high performance chromatography, both gel and capillary electrophoresis, and UV-visible spectrophotometers. Dr. Simonian has extensive experience both in academia and industry with animal cell culture with establishing primary cultures and use of cell culture lines. Recently, Dr. Simonian has developed and validated cell-based assays and immunoassays for medical device companies to be used in lot release testing. In addition, he has experience as a quality assurance internal auditor, root cause analysis of quality issues and risk analysis for new products.

Dr. Simonian has a Ph.D. in biochemistry and formerly was on the faculty at the University of Iowa where he taught and did basic research. He is member of the following professional societies: American Association for the Advancement of Science, American Association for Cancer Research, American Chemical Society (Division of Biological Chemistry), American Society for Biochemistry and Molecular Biology, and American Society for Cell Biology.

Follow us :