USP Education: Bioassay Design, Development and Validation course, September 20, 2019

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Workshop Overview

Development and analysis of robust bioassays that reflect the mechanism of action of a therapeutic product is always challenging, particularly for complex therapeutics. In addition, the role and requirements of the bioassay shift as a product emerges from research and evolves through development and commercialization.

USP is offering its 8th Bioassay workshop September 18-19, 2019 at the USP Meetings Center in Rockville, MD to bring together biologists, statisticians, and regulators to solve common issues related to bioassays. This workshop will give attendees the opportunity to consider and discuss bioassay methods from scientific, statistical, and regulatory perspectives, including the presentation of case studies. In addition to covering topics related to USP’s bioassay chapters and lifecycle management of bioassays, this year’s workshop will expand to cover challenges faced by cell and gene therapy products, which bring unique challenges to the development of a relevant bioassay for the measurement of potency. Novel bioassay formats for any type of therapeutic product, while bringing advantages, can also bring challenges to demonstrate that results align with previous bioassays that were used. Critical reagents, including reference standards, are also a focus of the workshop since they must be carefully selected, qualified, and bridged when replaced. Case studies will be presented that describe these challenges and the approaches used to create solutions.

Topics

• Regulatory expectations for bioassays
• Bioassay design and development, qualification, and continuous performance verification
• Cell and gene therapy potency assays
• Novel bioassay platforms
• Critical reagents including reference standards
• Updates on USP bioassay chapter revisions

Who Should Attend

• Biopharmaceutical and vaccines industry professionals
• Cell and gene therapy product developers
• Regulatory reviewers of bioassays
• Biosimilar manufacturers
• Bioassay software developers
• Statisticians
• QA/QC specialists for bioassays

Course Overview

This one-day bioassay course will focus on factors to be considered in the design, development, and validation of bioassays. The course introduces related USP general chapters, terminology, bioassay life cycle, important statistical tools and best practices, followed by a detailed discussion on the topics of design and development, robustness, validation, and post-validation and ends with an example of a USP Pharmacopeial bioassay. The course reflects statistical tools in USP General Chapters <111>, <1030>, <1032>, <1033>, and <1034>.

Course Objective

By taking this course, you will examine and apply:

• The structure of USP bioassay general chapters
• Applicable terminology
• Concepts of relative potency
• The bioassay life cycle
• Important tools and prerequisites
• Bioassay best practices
• Bioassay design and development
• Fitness for use/potential challenges
• Screening and optimization
• Number and spacing of standards for the curve
• Replication, uniformity, outlier detection, optimization
• Experimental design concepts and randomization
• Data and assumptions, variance heterogeneity
• Goodness for fit and measurement of uncertainty
• Normality, transformation, weighting
• Validity/assay/system/sample suitability criteria
• Acceptance criteria
• Robustness (experimental design concepts)
• Bioassay validation and post-validation
• Identifying and measuring significant sources of error
• Experimental design and acceptance criteria
• Statistical considerations involved
• Example of a USP Pharmacopeial bioassay

Target Audience

This course is designed for professionals who perform, supervise, manage, audit, or oversee the development and validation of bioanalytical assays.

Pricing Information

Pricing Registration is payable by credit card only. Registration fee includes the full two-day program, coffee breaks, lunches, and a networking reception. Registration fees for this workshop have been set as follows:

Early Bird Pricing: Register by July 31, 2019

Regular Fee Per Person - 1-2 individuals from the same organization

Multi-Registrant Price - 3 or more individuals from the same organization; all must register at the same time to receive the discount

Advance registration will be available through September 12, 2019, 12 noon EST. After that date, registration will be available on site at the USP Meetings Center starting at 8 am September 18, 2019. Onsite registration is not available for the USP Education course, "Bioassay Design, Development and Validation".

Cancellation and Substitution Policy

Cancellation must be received on or before September 5, 2019 via email to conferences@usp.org.

Refunds will not be issued for cancellations received after this date. There is a $100.00 processing fee on all cancellations; however, it is permissible to send a substitute registrant from your same organization without being subject to a fee for the change. Substitutions must be submitted in writing via email to conferences@usp.org

Invitation Letters for Visas:

USP cannot provide an invitation letter to potential workshop attendees; however, once you are registered, USP will provide a registration confirmation that may be utilized to obtain a visa.

Registration Questions:

Please contact conferences@usp.org or +1 301-816-8130

Local Area Information

Visit our Travel & Transportation page for information on lodging, airports, and local transportation in and around USP’s Rockville, Maryland, campus.