Annual BEBPA Bioassay meeting, September 24-26, 2014
Come hear the nitty-gritty details of the emerging new bioassay development tools, and importantly what can go wrong. Learn how you can avoid the looming pitfalls and use new approaches to accelerate your product development. Bioassay scientists gather here because they know that the most current topics, trends and problems will be discussed in an open, friendly and dynamic environment. This conference is designed by scientists, like you who must overcome the challenges of developing, validating, transferring and maintaining bioassays under strict, aggressive timelines.
Main Conference Topics Include:
Keynote Address: Gaze into the bioassay crystal ball with one of the industry’s most seasoned and knowledgeable practitioners. Hear what she thinks has impacted development practices and what is most likely to do so in the future. Featuring: Dr. Hélène Gazzano-Santoro of Genentech
Download the PDF
2014 BEBPA Bioassay Brochure
Case Studies Include:
- Case Study: Use of DOE Tools During Development and Optimization
- Case Study: PCR Read-out as a Bioassay Readout (Two Case Studies)
- Case Study: Blood Clotting Bioassay Development
- Regulator Perspective: Gene Therapy Vector Activity Assessment
- White Paper Review: Assay Acceptance Criteria Draft Paper
- Case Study: Bioassay as the Key Stability Indicating Assay
- Statistical Tools: Use of Bayesian Statistics to Solve Bioassay Problems
- Case Study: Developing Antibody Drug Conjugate Potency Bioassay
- And much more!
Plus! 2 Pre Conference Workshops
Workshop #1: Statistical & Practical Approaches to Handling Outliers & Noisy Data. This session starts with an overview of the regulatory environment, continues with an easy to understand, clear mini-tutorial to give you the vocabulary and knowledge to approach this topic and then follows with several case studies to highlight handling outliers within dose-response curve replicates and the dreaded
Workshop #2: In-depth Look at Validation Practices for Bioassays. With the advent of Quality by Design validations and the continued use of ICH approaches, the somewhat mundane activity of bioassay validation feels like a minefield. This workshop will review validation basics, which haven’t really changed and explore how it can be done today. As part of this workshop, case studies will be presented and a real time survey will be taken to help everyone understand the current practices.
- New analytical method technologies & challenges of current methodologies used for assessing residual HCP & DNA.
- The process and the host cell contaminants: What do we know? What should we know?
- What don’t we know?
- Implementing a control system: in-process vs. Certificate of Analysis testing vs. process characterization/validation (PC/PV); purposes and what the limits should be and what they should be based upon.
- Impact of host cell contaminants on clinical safety and efficacy.
- Host cell impurity profiles of biosimilars and follow-ons; requirements, comparability studies, and regulatory strategies.
- Global regulatory strategies for clinical and commercial products.
- Examples of how industry may leverage the newly released Chinese hamster ovary (CHO) genome information.
Documents & Forms
Click Here to Sign Up! Call for Abstracts PDF
USP and the Biopharmaceutical Emerging Best Practices Association (BEBPA) are please to invite you to submit abstracts for oral presentations or posters for this new workshop, to be held at USP Headquarters in Rockville, Maryland, June 3-4, 2013. This workshop is designed specifically for the biopharmaceutical industry and will focus on scientific, technical, regulatory, and clinical topics surrounding host cell proteins (HCP) and residual DNA. In particular we are looking for case studies from research, development, manufacturing, quality, control, regulatory, and clinical groups.
Who Should Participate
This workshop is intended for all stakeholders (industry, regulators, and associations) interested in characterizing and measuring these molecules in biotechnology products. This includes professionals working in or with:
- Research and development
- Contract research organizations
- Contract manufacturing organizations
- Regulatory affairs
- Quality assurance/quality control
For additional information, email us at firstname.lastname@example.org or call +1-301-816-8136
Helpful BEBPA.org Links
Download the PDF
2014 BEBPA Bioassay Brochure
We are currently accepting Topics and Abstracts for our 2014 meeting
Please go to our Abstracts Page and submit an abstract for review!