LGC BIOSEARCH Webinars

 

How to avoid the costly pitfalls of assay scale up

Overview

Leading R&D Scientists with expertise in assay component selection, component workflow integration, lyophilisation, point of care testing (POCT) assay cartridge design and assay manufacturing at scale join an expert in POCT regulatory approval to talk about the many issues assay designers face when scaling up to commercialisation. They discuss how to avoid the costly pitfalls that each aspect of the process can present and touch on the regulatory approval journey for POCT assays in cartridges.

Topics covered

• What are the pitfalls of assay scale up?
• Explore routes to solving problems presented by assay scale up (e.g. large-scale reproducibility and consistency).
• The importance of choosing the right components at design stage in order to avoid scale-up challenges.
• Resources that are available to assay designers to avoid scale-up problems.
• What are the steps to gaining POCT regulatory approval?

Speakers

Michaela Hoffmeyer
Director of Regulatory Affairs
TE IVD Solutions

Dipankar Manna
Senior Director of R&D
LGC Biosearch Technologies

Brian Catteneo
New Product Development Staff Engineer
TE IDV Solutions

Dr. Fraser Young
Senior Scientist
Biofortuna