Automating Cell-Based Assays and Reducing Variability and Time to Results

Cell-based assays play a critical role in assessing potency for traditional biologics and advanced therapeutics. In this presentation, the development of a cell-based potency assay on an automated platform is discussed.

Register Free: https://www.biopharminternational.com/bp_w/reducing-variability

Event Overview:

Cell-based assays play a critical role in assessing potency for traditional biologics and advanced therapeutics. For all analytical methods, increasing accuracy and precision while decreasing variability are critical to optimizing a method. For a cell-based assay, due to biologic nature, the variable material inputs provide a challenge. Therefore, other aspects of the analytical method need to be assessed for improvement opportunities. Removing variability through automation can help increase assay robustness and ruggedness, as well as reduce time to achieve results. In this presentation, the development of a cell-based potency assay on an automated platform is discussed.

Key Learning Objectives:

• Advantages (safety, performance, quality) of bioassay automation
• Comparisons between manual and bioassays automation
• How to adapt to automated bioassays

Who Should Attend:

• Procurement
• Head* of Mfg
• Head* of Ops
• Head* of R&D
• Head* of Sourcing
• Alliance Manager/External AM
• Head** of CMC
• Head** of Mfg
• Head** of R&D
• Head** of Analytical Development
• Head** of Product Development
• Head** of Formulation Development
• Consultants

*Head or a senior level of management **Head or any level of management

Speaker:

Luke Mercer
Manager, Bioassay
Catalent

Luke Mercer is the Bioassay Manager at Catalent’s Research Triangle Park location in North Carolina, and oversees assay development and QC testing for cell-based assays, ELISA’s and PCR. He has over 25 years of experience ranging from genomics startup, clinical stage biotech and contract organizations. Previously, he lead a discovery team at Cambrex, and prior to that was at GPC Biotech and Alphagene.

Register Free: https://www.biopharminternational.com/bp_w/reducing-variability