Within the Analytical, Formulation and Quality Track, thought-leaders in the field help you to stay abreast of emerging analytical tools and formulation strategies for MAb, non-MAb and next generation biotherapeutics. Learn about the impact of increasing quality expectations for your products and processes so you can optimize your analytical and formulation strategy and reduce quality risk across the product lifecycle.
Implementing Multi-Attribute LC/MS Methods for More Informed Process Development
Matthew Traylor, Analytical Scientist, Process Development, Shire
Full Presentation: 9:20 am, Tues. Oct. 27, 2015
Matthew Traylor discusses how he gets a deep characterization a specific protein out of a mixture, using LC/MS software packages that automate the process. He shares how this technology can be used at laboratory, pilot and production scale process development.
Please log in to access this content.
Continued Process Verification (CPV) Informatics Systems and Validation
Carly Cox, Senior Process Engineer, Pfizer
Full Presentation: 9:20 am, Weds. Oct. 28, 2015
Carly Cox describes what a CPV informatics system is and how it’s used in product manufacturing. She’ll be presenting at the BioProcess International Conference on how multiple source systems can pull data on product manufacturing processing and be collected into a CPV informatics system, and some of the important areas to consider for validation and configuration for regulatory reporting and process monitoring.
Please log in to access this content.
Rapid Microbiological Methods for Real-Time Release of Autologous Cell Therapy Products
John Duguid, Principal Scientist, Vericel Corporation
Full Presentation: 2:00 pm, Thurs. Oct. 29, 2015
Hear about how a risk based approach to autologous cell therapy products used at Vericel. In this podcast John Duguid describes how rapid microbiological methods are used in product release of autologous cell therapy products, and discusses the areas of contamination risk.
Please log in to access this content.
View the complete Analytical, Formulation and Quality speaker line-up.