Cell-Based Assays in a GMP Environment: Approaches for Clinical and Commercial Stability Studies


Instructor: Todd Graham
Product ID: 706246
Training Level: Basic to Intermediate

  • Duration: 60 Min
This 1-hr virtual seminar will teach how to integrate cell-based assays into your GMP processes to ensure success of GMP-mandated stability studies. You will learn critical information about GMP requirements, how to validate bioanalytical methods, how to use cell based assays for clinical work and commercial work.
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Why Should You Attend:

Cell-based assays are commonly used in a GMP environment to support the scientific needs of GMP-mandated stability studies. While these studies are broadly understood, using cell-based assays in a GMP context has some key requirements to ensure the success of such a study. In this webinar, the goal will be to ensure that the right cell-based assay is used for the right study. We will also look at what is required in support of clinical assays versus the support of commercial products, as those two categories have different needs in support of GMP regulations.

Areas Covered in the Webinar:

This webinar will help you learn how to validate bioanalytical methods. The webinar will include the following critical information you will need:

  1. What is required of GMP?
  2. What is a cell based assay?
  3. What are the requirements for GMP for cell based assays
  4. What are stability studies?
  5. How do cell based assays work for clinical work?
  6. How do cell based assay work for commercial work?

Who Will Benefit:

This will benefit a wide array of professionals such as:

  • Quality assurance
  • Regulatory affairs
  • Assay development
Instructor Profile:
Todd Graham

Todd Graham
Managing Partner, Delevan Street Biosciences

Todd Graham is a clinical laboratory scientist for a large hospital system in the New York Tri-State Area as well as a scientific consultant for Fortune 500 biotechnology firms, healthcare systems throughout the world and R1 Research Level Universities. During his time as a clinical laboratory scientist in his current role, he has improved sample workflow and improved laboratory quality and sample turnaround time while expanding laboratory services to vulnerable health populations in the New York area. He has also provided outreach to the local community by serving as a mentor to students training in clinical laboratory science, as well as the scientific community by serving as a technical resource for his peers in the laboratory.

Through his work as a consultant, he has worked to improve the spread of key technical information in a variety of mediums. Todd has written a number of market research reports used by Fortune 500 biotechnology firms in strategic planning, and led webinars on key quality issues that impact the biotechnology community. He has served R1 Research Level Universities by advising them on strategic technology transfer opportunities, and has been called upon as a key knowledge leader internationally for the biotechnology industry.

Todd Graham graduated in 2006 with a MA in Biology at Queens College (City University of New York) after conducting published research in Molecular Evolution in the laboratory of Dr. Stephane Boissinot. He graduated as a Dean’s List student and James Dickson Carr Scholar from Rutgers University in 2001 with a BS in Biotechnology, where he continues to mentor Biotechnology students. He is a member of the Society for Laboratory Automation and Screening. He is also licensed as a Clinical Laboratory Technologist in New York State and is certified in Molecular Diagnostics by the American Society for Clinical Pathology.

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