Validation of Potency Bioassays for Biologicals

Instructor: Ana Menendez
Product ID: 700201
  • Duration: 60 Min

recorded version

1x Person - Unlimited viewing for 6 Months
(For multiple locations contact Customer Care)
Recorded Link and Ref. material will be available in My CO Section
Last Recorded Date: Oct-2007

Training CD / USB Drive

One CD/USB is for usage in one location only.
(For multiple locations contact Customer Care)
CD/USB and Ref. material will be shipped within 15 business days

Customer Care

Fax: +1-650-362-2367


Read Frequently Asked Questions

This Validation of Potency Bioassays training/webinar for Biologicals provides logical approaches that should be implemented during early development to increase predictability and deliver rugged, compliant assays through Phase III and commercialization.

Why Should You Attend:

Potency bioassays are a regulatory requirement for all biopharmaceutical products yet validation guidelines are vague due to the large assortment of end points and targets. An additional obstacle is the perceived variability of the methods resulting in unacceptable failure rates due to unreliable accuracy and precision. The seminar also reviews critical validation parameters and uses case studies to highlight common pitfalls and their solutions.

What will Attendees Learn?

  • Selecting the appropriate bioassay for your product
  • Preparation of GMP cell banks
  • Maximizing precision and accuracy
  • Setting specifications for the validation protocol
  • Recognizing differences between Phase I/II and Phase III Validations
  • Common pitfalls and solutions
  • Case Studies

Who Will Benefit:

  • Bioassay and analytical scientists
  • Validation specialists
  • Project Management
  • Regulatory staff
  • QA/QC
  • Outsourcing Professionals
  • Consultants

Instructor Profile:

Ana T. Menendez ,is Senior Director of Biotechnology at Catalent, a full-service solution provider to the pharmaceutical industry. Dr. Menendez implemented biotesting at Catalent with the following services: Cellular Technologies, Molecular Technologies and Virology. The expertise of the department ranges from proteins (i.e., monoclonal antibodies, enzymes, growth factors) to therapeutic viruses, bacterial vaccines and aptamers.

Dr. Menendez joined Catalent from Bristol-Myers Squibb (BMS) where she held a number of positions of increasing responsibility from 1995 to 2001. As the head of the Cancer Cell Biology department Dr. Menendez identified and/or optimized several compounds currently in clinical trials, including second-generation taxanes and inhibitors of the ras and src oncogenes. Her seminal apoptosis research (programmed cell death) was critical to the incorporation of a drug’s pro-apoptotic potential into the BMS decision pathway for oncology drug generation. While Associate Director of Regulatory Sciences she assisted the transition of Oncology and Infectious Diseases leads from the lab bench to the clinic. From 1982 to 1995, Dr. Menendez pioneered monoclonal antibody technology at American Cyanamid/Wyeth and was responsible for all the immunoassays and in vitro bioassays for Mylotarg, an anticancer monoclonal antibody – toxin conjugate that was approved in 2000.

Dr. Menendez obtained her Ph.D. in Microbiology/Immunology in 1995 from NY Medical College while simultaneously fulfilling her supervisory functions at Wyeth. She teaches courses and leads workshops on Bioassay Method Development and Validation and is a frequent speaker at biopharmaceutical conferences.

Follow us :
The A to Z's of Microbial Control, Monitoring and Validation of Water Systems
Upcoming In-person Seminars by EX-FDA OFFICIALS

Refund Policy

Registrants may cancel up to two working days prior to the course start date and will receive a letter of credit to be used towards a future course up to one year from date of issuance. ComplianceOnline would process/provide refund if the Live Webinar has been cancelled. The attendee could choose between the recorded version of the webinar or refund for any cancelled webinar. Refunds will not be given to participants who do not show up for the webinar. On-Demand Recordings can be requested in exchange.

Webinar may be cancelled due to lack of enrolment or unavoidable factors. Registrants will be notified 24hours in advance if a cancellation occurs. Substitutions can happen any time.

If you have any concern about the content of the webinar and not satisfied please contact us at below email or by call mentioning your feedback for resolution of the matter.

We respect feedback/opinions of our customers which enables us to improve our products and services. To contact us please email call +1-888-717-2436 (Toll Free).

Product Reviews Write review

Thank you for the excellent customer service and technical help!
- Anonymous

Best Sellers
You Recently Viewed