Caliper Life Sciences, Inc. (Nasdaq: CALP), a leading provider of life sciences tools, presented at a training session for reviewers from the United States Food and Drug Administration (FDA) on the benefits of the LabChip GX platform for high throughput screening and characterization assays for biological drugs.
"We were pleased to accept the FDA's invitation to present our LabChip platform to a large group of reviewers. We believe the LabChip platform will accelerate the adoption of quality-by-design approaches that ultimately will improve the safety profiles of new biologics and vaccines," said Kevin Hrusovsky, CEO of Caliper Life Sciences. "Additionally, our discussions with FDA officials indicate that Caliper's LabChip platform may have applications for downstream manufacturing release assays and potentially as an inline quality control technique."
Caliper invited pioneers in this field from Pfizer (PFE), Amgen (AMGN), and Biogen Idec (BIIB) to describe their analytical approaches for biologics characterization. These leading scientists presented to a standing-room-only group of approximately 75 FDA personnel and described an industry-wide need for analytical techniques that provide high throughput, predictive assessments of biological product quality. This need is being addressed by Caliper's LabChip GX platform, which provides high resolution analytical data on a time scale that is approximately 70 times faster than conventional capillary electrophoresis.
In addition to these presentations at the FDA, more than 60 scientists have presented their research using Caliper's technologies this year at user meetings attended by more than 600 current and potential customers.
Caliper Life Sciences, Inc.