Thursday, April 17, 2014

13 Steps To Successful Potency Assays

Today, we feature an article from BioProcess International magazine co-authored by Biological Assays event chair. Laureen E. Little, Ph.D., Principal Consultant, Quality Services.

  1. 1. Acquire as broad and in-depth as possible an understanding of the biological and other properties and actions of the cellular therapy product(s) for which you wish to develop potency methods. You should collect sufficient product characterization data (molecular, biochemical, immunologic, phenotypic, hysical, and biological properties) throughout preclinical and clinical development to inform and refine your approach to measuring potency.
  2. 2. Acquire broad and in-depth knowledge of the process by which your cellular product is manufactured.
  3. 3. Familiarize yourself with the way in which the product is administered and the events that follow administration.
  4. 4. Start designing and developing two (or possibly more) potency assays early — as early as during preclinical development is desirable. Developing at least two different methods increases your chances that one of them will be suitable for both your company and the regulators.
  5. 5. Realize that biological potency assay design and development for GMP use requires considerable, specialized, and varied knowledge and experience. If you are not already an expert, either become one (for suggestions, see box, Gaining Expertise in Biological Potency Method Development”), find and apprentice yourself to one in your organization, hire one, or engage the services of an expert consultant. Be sure to confirm that any prospective employee or consultant has specific knowledge and experience in developing and validating biological potency assays.
  6. 6. Initiate and maintain a discussion with your CBER Reviewers so that you have agency feedback to assist in your development decision making.
  7. 7. Familiarize yourself with all relevant regulations and guidance and get current and stay current with the technical literature.
  8. 8. Thoroughly characterize all rare and other reagents, reference materials, standards, and controls.
  9. 9. Thoroughly characterize and qualify your potency assay(s).
  10. 10. Give regular technical presentations to gain input from your colleagues.
  11. 11. Be diligent in creating a formal Method Development Plan and in keeping a Development Report and refer to them often.
  12. 12. Determine the robustness of, and validate your potency method(s) before your end of phase 2/pre-pivotal trial meeting with FDA
  13. 13. If you outsource development of your potency assay(s), always have a knowledgeable and experienced employee or consultant, whose services your company has engaged, guide and manage the product development.

Would you like to meet with Dr. Little?  Dr. Little will be hosting the workshop A Practical Guide to the Development of Assays for Evaluation of Biologics and Biotherapeutics – a Systematic Approach to Supporting Product Development in the Regulatory Environment on Monday, May 5 in Berkeley, California at Biological Assays.  For more information on her workshop and the rest of the event, which takes place May 5-7, download the agenda. As a reader of this blog, you are eligible save 20% off the standard rate when you register to join us and mention code B14177JT.

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