Neutralizing Antibody Assay Conference, January 26-27, 2015; Palm Springs, CA
Neutralizing antibody assays are some of the most difficult analytical methods in the biopharmaceutical arena to develop. They are biological assays, requiring complex biological components such as cells, limit of detection is a key parameter and our clinical samples contain sera. And this names only a few of the hurdles. Yet these assays are adamantly required to support clinical product development because they are key safety and efficacy assays which speak to how well products work in patients. You would think that because of their criticality and difficulty, there would be many arenas for discussion of these assays. Instead conference organizers have turned their backs on this important topic, until now. This workshop, put together by a group of scientist working in this field is the first workshop dedicated to this topic. Come learn how to develop, validate, establish cut points, and run you assay to support clinical trials. This conference is designed to help you.
More information on this event coming soon!
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.
- 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!