Training Seminars

Monday August 13 and Tuesday August 14
Day One 1:00 – 5:00 pm Day Two 8:00 am – 5:00 pm

Potency Bioassay: Practical Approaches to Development and Validation

Instructor

Laureen Little, PhD, Principal Consultant, Quality Services and President, BEBPA


The potency bioassay is considered a critical release assay for biopharmaceutical products. Why? Because these molecules are complex, and it is physically impossible to ascertain every permutation of a manufactured product and its impact on biological activity. Instead we develop a potency assay which is a quantitative, comparative assay, to prove the biological activity of each lot is consistent. We have a biologically and statistically complex assay which receives high scrutiny from the regulators. This course will help you through this murky design space, by introducing you to some basic potency assay “tricks of the trade.”

Topics include:

  • What is potency and how do we calculate it?
  • Understanding the dose response curve and preparing it for a potency calculation.
  • Judicious use of outlier strategies to provide the estimate of potency.
  • System suitability for assays and test samples.
  • Combining replicate values to achieve a reportable value.
  • Understanding OOS vs. retest situations for potency assays.
  • Understanding how to develop rugged biological components.
  • ICH vs. USP validation; how to achieve the best of both worlds.
  • Repeatability, a better approach to estimating within plate precision
  • Changing formats; a controversial approach.
  • Use of capability calculations to estimate validation criteria.

Instructor Biography:

Laureen_LittleLaureen Little, PhD, Principal Consultant, Quality Services and President, BEBPA

Laureen Little has over 25 years of biotechnology experience. She is a principal consultant with Quality Services, specializing in Biological Assay optimization and validation.

Laureen has worked with many firms developing, qualifying and validating biological potency assays for BLA submissions, Pre-Approval Supplements for commercial products and special amendments to support facility/manufacturing changes. The various products she has worked with include: monoclonal antibodies, rDNA products, peptide hormones, CBER regulated devices, gene therapy products, autologous cell therapies, toxins, cancer vaccines, viral vaccines, prophylactic vaccines, blood products, enzyme therapeutics, anti-angiogenic drugs, lipid-based therapies. The potency assays have included animal model systems, cell-based methods and binding assays.

Additionally Dr. Little has worked with firms to develop non-potency biological assays for analysis of patient samples. Assay types include elisas, PCR assays, and various microbiological assays.

Dr. Little is also the president of Biopharmaceutical Emerging Best Practices Association (BEBPA; www.bebpa.org) a non-profit organization she founded in in 2007 to promote scientific conferences for scientists working in the biopharmaceutical industry. BEBPA now hosts 3 to 4 conferences annually on such topics as potency bioassays, Host Cell Proteins, Immunogenicity assays. The organization has grown over the past decade and is now recognized as the venue for frank, open discussion and has resulted in vast improvements in technical approaches in various aspects of analytical development.

Laureen’s formal education includes: Ph.D from UCSD department of Chemistry purifying and studying glycoproteins and their carbohydrate dependent properties; B.Sc from U. of Washington in Molecular Biology

She has also led various professional courses including: Statistics, Statistical Experimental Design, GLP training, GMP training and Auditing Training.

Training Seminar Information:

Each CHI Training Seminar offers 1.5 days of instruction with start and stop times for each day shown above and on the Event-at-a-Glance published in the onsite Program & Event Guide. Training Seminars will include morning and afternoon refreshment breaks, as applicable, and lunch will be provided to all registered attendees on the full day of the class.

Each person registered specifically for the training seminar will be provided with a hard copy handbook for the seminar in which they are registered. A limited number of additional handbooks will be available for other delegates who wish to attend the seminar, but after these have been distributed, no additional books will be available.

Though CHI encourages track hopping between conference programs, we ask that Training Seminars not be disturbed once they have begun. In the interest of maintaining the highest quality learning environment for Training Seminar attendees, and because Seminars are conducted differently than conference programming, we ask that attendees commit to attending the entire program, and not engage in track hopping, as to not disturb the hands-on style instruction being offered to the other participants.

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