May 14-15, 2015, San Francisco, CA
Host Cell Proteins can become stumbling blocks on your company’s way to gaining product approval. If you are tasked with developing these critical assays, you need to make sure that your group know and understands what is expected. Three of the top reasons to attend this year’s BEBPA Host Cell Protein (HCP) Conference/Workshop include:
- Health Authorities world-wide are increasingly asking questions about biopharmaceutical product purity assessments.
- Both the US Pharmacopeia and EU Pharmacopeia will issue guidance documents this year on HCP measurements.
- The analytical landscape of how to quantify HCPs is radically changing with the use of LC-MS/MS.
Come hear speakers from major biopharmaceutical companies, biosimilar companies, analytical instrument and service companies, discuss their experiences developing, validating and using HCP assays.
Find out firsthand the new evolving best practices for HCP impurity measurements. Speakers will present case studies and discuss optimal strategies for developing immunoassays with broad coverage of HCP populations. Use of HCP assays for process development, process validation and GMP testing will also be covered.
Important talks will focus on presenting tips for avoiding common errors in HCP assay assessment. So much better to hear these at the workshop, than from the regulators’ response to your submission! Additionally, emerging practices with the application of proteomic LC-MS/MS methods to HCP assessment will cover fundamental topics such as sensitivity, software for database matching, sample throughput, and integration of proteomic data into manufacturing control systems you need to get these systems running in your facility. And finally, a talk will be included about risk assessment strategies for setting limits on HCPs to help you determine how important these methods are for your product.
September 23-25, 2015, Budapest, Hungary
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.
- Development, Qualification and Validation of Multiplex Assays.
- The Role of Bioassays in Comparability Protocols.
- The Caring and Feeding of Rare Reagents, including Cell Banks and References for Potency Assays.
- Product Specific Potency Assays, including Antibody Products, APC, Natural Products, Hormones, etc.
- New and Novel Assay Methods and Read-Outs.
- Monitoring and Maintaining the Bioassay.
- Statistical Tools and Practical Case Studies Utilizing Them.
- Regulatory Insights into the Role of Bioassays to Support Product Development.
- Selecting the Appropriate Bioassay for your Product.
- Potency Assay Validation Case Studies.
Helpful BEBPA.org Links
- Sign up today for BEBPA’s 2015 Conferences with our secure form here!
- 2015 Host Cell Protein Workshop Brochure
- 2014 BEBPA Bioassay Meeting Brochure
- Past Conferences
We are currently accepting Topics and Abstracts for our 2015 meetings.
Please go to our Abstracts Page and submit an abstract for review!