Method Development and Validation for Assays Supporting Testing of Biologics: 2-Day In-Person Seminar

By: Gwen Wise-Blackman, Ph.D, Principal Consultant, Gwen Wise-Blackman Consulting, LLC.
Location :- The Citrus Club, Orlando, FL | Thursday, March 22, 2018 | Friday, March 23, 2018

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Course Description:

Biologics continue to be a steadily growing component of the pharmaceutical industry. The advent of large molecule therapeutics requires a different perspective on the assays needed to support development through preclinical and clinical testing.

This 2-day seminar is designed to offer a broad overview of developing and validating a range of assay methodologies for biologics with specific key analysis of cell culture, assay variability, and DOE. Specifically, this seminar covers essential concepts related to cell-based potency methods, ELISA, and other methods supporting biologics. In addition to potency methods this seminar addresses immunogenicity methods for preclinical and clinical studies. The format of the seminar offers an examination of current best practices as well as time to dissect examples of documentation with emphasis on beneficial systems to consider. Scientists who attend this 2-day seminar will gain knowledge that will be beneficial in helping to achieve well-controlled validated methods.

Learning Objectives:

  • Understanding the different requirements for small versus large molecules
  • Mapping appropriate timelines with decision points
  • Designing, developing, optimizing, and validating key methods
  • Potency methods, other release and stability methods
  • Preclinical and clinical methods
  • Use of DOE and statistical analysis
  • Handling of critical materials
  • Process monitoring concepts
  • Assessment of orthogonal methods
  • Assessing readiness for validation
  • Defining the validation protocol with real-time capture of data analysis
  • Maintaining quality through documentation

Who will Benefit:

Below titles working in biopharmaceuticals, pharmaceuticals, natural products/botanicals will be benefited by attending this seminar:

  • Validation Scientists
  • QA/QC
  • Regulatory Affairs
  • Laboratory Managers
  • Assay Development Specialists
  • Statistician
  • CMC Titles
  • Bio Assay

Course Outline

Day One (8:30 AM - 4:30 PM)

  • Registration Process: 8:30 AM – 9:00 AM
  • Session Start Time: 9:00 AM
  • Overview of Biologics and Biotechnology
  • Differences between small molecule and large molecule therapeutics
  • Assays required for biologics
  • Timelines
  • Regulatory guidances
  • GxP in biologics
  • Analytical CMC methods and bioassays
  • Assays supporting product development, release, and stability
  • Portfolio of required assays
  • Mechanism of action and potency methods
  • Selection of potency-indicating method(s)
  • Assay formats/platforms
  • Consideration of reagents, endpoints, signal to background
  • Standardizing cell culture procedures
  • Understanding and managing assay variability
  • Overview of feasibility to validation
  • Early development - feasibility
  • Use of DOE
  • Involvement of statisticians
  • Development and final development
  • Optimizing the assays
  • Validation of cell-based methods
Day TWo (8:30 AM – 4:30 PM)

  • Assays supporting preclinical and clinical studies
  • Regulatory guidance
  • Assay platforms
  • Reagents, endpoints, signal to background
  • Method development
  • Assessing matrix effects
  • Method optimization
  • Validation parameters
  • Incurred sample reanalysis
  • Immunogenicity methods
  • Screening methods
  • Confirmatory methods
  • Neutralizing antibody method
  • Biomarker validation
  • Written procedures (methods, protocols, SOPs)
  • Analyst training
  • Maintaining quality in-house and in outsourcing

Meet Your Instructor

Gwen Wise-Blackman
Gwen Wise-Blackman
Principal Consultant, Gwen Wise-Blackman Consulting, LLC.

Gwen Wise-Blackman, Ph.D., has 20 years of combined experience in Cell-Based Assays and Quality Systems. She has worked at DuPont Pharmaceuticals, Catalent Pharma Solutions (formerly Magellan Laboratories and Cardinal Health), and Salix Pharmaceuticals. She is currently Principal Consultant at Gwen Wise-Blackman Consulting. Her career focus has been in High-Throughput Screening, Cell-Based Assay Method Development and Validation, and Quality Assurance. Gwen has a Bachelor of Science degree in biology from M.I.T and a PhD in Pharmacology from UVa. She is a member of ASQ and AAPS.


Location :
The Citrus Club,
255 South Orange Avenue,
Suite 1800,
Orlando, FL 32801, USA
March 22-23, 2018

How to Reach

General Driving Directions:

Driving directions from Orlando International Airport - 12.8 miles:
  • Head north on S Access Rd/Jeff Fuqua Blvd
  • Continue to follow Jeff Fuqua Blvd
  • Keep left to continue on S Semoran Blvd
  • Use the right lane to take the ramp to Downtown/Orlando
  • Merge onto FL-408 W/Hwy 408 W
  • Keep left at the fork to stay on FL-408 W
  • Use the right 2 lanes to take exit 11A for FL-15 toward Rosalind Avenue
  • Use the right lane to turn left onto E South St
  • Turn right onto S Rosalind Ave
  • Turn left at the 3rd cross street onto E Pine St
  • Turn left at the 3rd cross street onto S Orange Ave
  • Destination will be on the left

Disclaimer: Directions to the venue above have been taken from the hotel website. Attendees are advised to check with the hotel for confirmation of these directions before starting for the venue. GRC Seminars is not responsible for any inaccuracies in the same.
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Seminar One Registration

March 22-23, 2018, Orlando, FL

Early bird seats are limited and based on first-come, first-serve.

The registration fee includes: the workshop; all related course materials; morning tea/coffee, lunch and afternoon tea/coffee on both days.
For discounts on multiple registrations, contact customer care at +1-1-888-771-6965.

Group Registrations

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Significant tuition discounts are available for teams of two or more from the same company. You must register at the same time and provide a single payment to take advantage of the discount.

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Your Registration for the seminar is subject to following terms and conditions. If you need any clarification before registering for this seminar please call us @ +1-888-771-6965 or email us @


Payment is required before 2 days of the date of the conference. We accept American Express, Visa and MasterCard. Make checks payable to MetricStream Inc. ( our parent company)

Cancellations and Substitutions:

Written cancellations through fax or email (from the person who has registered for this conference) received at least 10 calendar days prior to the start date of the event will receive a refund — less a $300 administration fee. No cancellations will be accepted — nor refunds issued — within 10 calendar days from the start date of the event.

On request by email or fax (before the seminar) a credit for the amount paid minus administration fees ($300) will be transferred to any future GRC Seminars event and a credit note will be issued.

Substitutions may be made at any time. No-shows will be charged the full amount.

We discourage onsite registrations, however if you wish to register onsite payment to happen through credit card immediately or check to be submitted onsite. Conference material will be given on the spot if it is available after distributing to other attendees. In case it is not available we will send the material after the conference is over.

In the event GRC Seminars cancels the seminar, GRC Seminars is not responsible for any airfare, hotel, other costs or losses incurred by registrants. Some topics and speakers may be subject to change without notice.

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After we receive the payment from the registered attendee an electronic event pass will be sent to the email address associated with the registrant before 5 working days from the seminar date. Please bring the pass to the venue of the event.

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Orlando, FL, Local Attractions

Walt Disney World Resort
This massive, world-famous theme park includes Magic Kingdom Park, Disney - MGM Studios, Epcot, Disney's Animal Kingdom, Downtown Disney, and more.

Magic Kingdom Park
Opened in October of 1971. One of the most famous theme parks in the world featuring Cinderella's castle with classic rides like Pirates of the Caribbean, Haunted Mansion, Space Mountain, Country Bear Jamboree, Hall of Presidents, etc. Frontierland, Tomorrowland, Liberty Square, Adventureland, and Fantasyland, Great for families with kids 10 and younger.

Universal Studios Orlando
Theme studios park features Jaws, T2, Twister, Men In Black, etc. and various back lot sets used in the movies. CityWalk is an entertainment venue with many restaurants, night clubs, retails stores and a great party atmosphere. Movie theatre near the entrance. Also Hard Rock Cafe, Jimmy Buffet's Margaritaville, Emiril's, NASCAR Cafe.

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Pointe Orlando
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Holy Land Experience
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