Date: January 30 - February 1, 2018
Location: The Mayflower Hotel
Washington, DC, USA
The WCBP Symposium series was created to address issues at the interface of analytical development and global regulatory for biotechnology derived health intervention products. The goal of this Symposium series is to provide a forum for discussing the latest bioanalytical methods and their practical application to biotechnology pharmaceuticals and other health related products. Both state-of-the-art innovations as well as conventional technologies addressing research and routine testing applications will be covered. This includes both method and instrumental advances that are used for product characterization, process development, in-process analysis and validate release and stability testing.
Date: January 30, 2018
Time: 1:00pm - 2:00pm
Title: New Directions in Cell Banking and Assay Automation
Presenters: Michael Merges and Michael Sadick, Ph.D., Catalent
Abstract: In our continuous effort to provide value-added service to Biologics clients, Catalent Biologic Analytical Services is expanding, developing and optimizing capacities for both the generation of analytical cell banks as well as application of automation to ELISA and bioassay preparation and execution.
Establishment of dependable master and working analytical cell banks (MACB and WACB, respectively) is an essential foundation of a strong and dependable bioassay program. The fact that there are so many different types of cell and cell lines, each one often with quite particular growth needs and characteristics (e.g., adherent vs. non-adherent), presents a number challenges. Additionally, some bioassays utilize cells immediately from thaw (Thaw&Go), while other bioassays use cells maintained in continuous culture, necessitating different approaches to cell bank generation. We will describe the strategies and equipment/instrumentation we are putting in place to generate consistent MACBs and WACBs. These include strategies for both Thaw&Go cell banks as well as continuous culture cell banks, for both adherent and non-adherent cells and cell lines.
Execution of bioassays and ELISAs presents challenges on many fronts. Among these challenges is the fact that, due to the multitude of micro-pipette based dilutions and liquid transfers, using both single channel and multi-channel pipettes, there is always a high risk of operator fatigue and/or injury (repetitive stress). These risk factors, in turn, result in a high risk of operator error. Additionally, utilization of laboratory scientists to execute established and predictable/routine analytical operations means that these individuals are not available for analytical activity, such as development or validation, which would require more customized and interpretive support. To this end, we are increasing and optimizing our operations based upon automation. We will describe the strategies and equipment/instrumentation we have and additional ones we are putting in place adapt assays, ELISA, bioassay and molecular, to automated approaches.
Poster Title: A Rapid New Hydrophilic Interaction Liquid Chromatography Method to Quantify Polysorbate Excipients