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.

13 Steps To Successful Potency Assays

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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Biological Potency Assays Grow in the Importance

We've teamed up with BioQuality to bring you their Bioassay Special Edition of 2012. Articles covered include Biological Potency Assays Grow in the Importance: Assays have Both a Long History and a Critical Modern Role and BioAssay Conferences: Technical and Regulatory Info- All Agree that Mechanism of Action is the Key.

Here's an excerpt from Biological Potency Assays Grow in the Importance: Assays have Both a Long History and a Critical Modern Role:

Biological potency has long been considered a critical quality attribute, (CQA), in fact longer than the snappy CQA acronym. The first FDA regulated product, with a quantitative potency assay, surfaced in 1949. 

Dr. Margaret Pittman, director of the Biologic Control Laboratory (forerunner of CBER), developed a potency assay for the pertussis vaccine and correlated potency with human efficacy. It quickly became a standard release assay. 

The method was a lethal dose 50% (LD50) assay. The LD50 value was estimated without computers using a probit. The assay required 16 or 32 animals per testing group.
Compare to today, in which commercial software providers duke it out for market share, biological read-outs include animals, tissues, cultured cells, frozen ready-to-use cells and statisticians argue nuances of determining similarity between test and
reference samples. 

However, what has not changed since the 1940’s when Dr. Pittman was doing her ground-breaking work, is the singular lack of guidance on what the regulatory expectations are for the method. 

Since the late 1990’s, the potency assay has been touted as the critical quality assay to support comparability studies, development and release of biopharmaceuticals. Now with the advent of BioSimilar products, there is an even stronger emphasis on potency bioassays. 

The original pertus sis potency assay become both a release assay and a surrogate for human efficacy. This is now considered the holy grail of bioassay, but is not typically achieved outside of the vaccine industry. Even here, it is only commonly accepted for challenge animal potency assays. Newer, binding or neutralization vaccine potency assays still meet strong resistance if trying to claim the ability to predict efficacy.

Download the full article here.

This May in Seattle, IBC will host the 23rd International Biological Assay conference which will focus on these topics and more. For more information on the program, download the agenda.  If you'd like to join us in Seattle, as a reader of this blog when you register to join us and mention code Bio13JP, you'll save 20% off the standard rate!   

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Cell Based Assays 2009

In its fifth year, IIR’s Cell Based Assays is the principal event for industry leaders and colleagues to discuss how to overcome the challenges of cell based assay development and validation.

For 2009, we have added more networking time for you and your peers, including the return of moderated round table sessions that will allow you to address all your current questions surrounding: regulatory considerations, assay development and validation efficiencies, potency assays, neutralization antibodies assays, technological advancements, statistical analysis, and more.

Additionally, we have organized a Dine-Around which will provide the ultimate Berkeley experience. This dinner is a venue for conference participants to meet others with similar interests, for Berkeley is an epicenter of food culture that offers an eclectic range of restaurants.

Don’t forget - make sure you register by this Friday, July 24th, to save $400 off the standard rate!

We also invite you to join our LinkedIn group to start networking with other professionals in the Cell Based Assays field to discuss such things as biopharmaceutical labs have many obstacles to overcome in developing, validating, maintaining, and transferring complex cell based assays in a quality control environment.

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