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 :- DoubleTree by Hilton San Francisco Airport, CA | Thursday, June 21, 2018 | Friday, June 22, 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.

Venue

Location :
DoubleTree by Hilton San Francisco Airport
835 Airport Blvd,
Burlingame, CA, 94010-9949, USA

June 21-22, 2018


How to Reach

General Driving Directions:

Directions from San Francisco International Airport, CA: 4.8 mi.
  • Depart from San Francisco International Airport, CA
  • Take ramp left for US-101 South toward San Jose (2.5 mi.)
  • At exit 419B, take ramp right and follow signs for Broadway (0.2 mi.)
  • Turn left onto Broadway (0.2 mi.)
  • Turn right onto Old Bayshore Hwy / Bayshore Hwy (0.1 mi.)
  • Turn left onto Airport Blvd (0.7 mi.)
  • Arrive at Airport Blvd on the right (0.0 mi.)
Directions from San Jose International Airport, CA: 31.1 mi.
  • Depart Airport Blvd toward Airport Blvd (1.0 mi.)
  • Bear left toward Skyport Dr (0.3 mi.)
  • Keep straight onto Skyport Dr (0.1 mi.)
  • Take ramp left for CA-87 N / Guadalupe Pkwy (0.7 mi.)
  • At exit 9B, take ramp left for US-101 North toward San Francisco (28.6 mi.)
  • At exit 419A, take ramp right and follow signs for Anza Blvd (0.2 mi.)
  • Keep straight onto Anza Blvd (0.2 mi.)
  • Turn right onto Airport Blvd (0.0 mi.)
  • Arrive at Airport Blvd on the right (0.0 mi.)
Directions from Metropolitan Oakland International: 27.5 mi.
  • Depart Airport Dr toward Airport Dr (0.3 mi.)
  • Turn right onto Alan Shepard Way (0.0 mi.)
  • Turn right onto John Glenn Dr (0.5 mi.)
  • Turn right onto Ron Cowan Pkwy (0.0 mi.)
  • Take ramp left for Airport Dr (0.7 mi.)
  • Turn right onto CA-61 / Doolittle Dr (0.9 mi.)
  • Keep left to stay on CA-61 / CA-112 / Davis St (0.5 mi.)
  • Take ramp right for I-880 South toward San Jose (6.7 mi.)
  • At exit 27, take ramp right for CA-92 West toward San Mateo Br (13.1 mi.)
  • At exit 13B, take ramp right for US-101 toward San Jose / San Francisco (4.1 mi.)
  • At exit 419A, take ramp right and follow signs for Anza Blvd (0.2 mi.)
  • Keep straight onto Anza Blvd (0.2 mi.)
  • Turn right onto Airport Blvd (0.0 mi.)
  • Arrive at Airport Blvd on the right (0.0 mi.)

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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$1,699

Seminar One Registration

June 21-22, 2018, San Francisco, CA

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.

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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.

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Local Attractions

Think Escape Party Bus
Board a luxurious Think Escape party bus or limo and be whisked away to San Francisco's hottest nightclubs where VIP treatment brings all party bus guests to the front of the line. Planning the perfect night on the town is easy with Think Escape's fleet of luxury buses and extended vehicles, each with different amenities for socializing and transport.

Alcatraz Lunch Cruise
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