In the first part of a two-part interview, Paz Vellanki of Precision for Medicine explains what sponsors should bring to early FDA meetings and how manufacturing and assay readiness can delay rare disease trials.
|Articles|February 2, 2015
Precision Biologics Enlists the Help of EMD Millipore for Upstream Process Development
Author(s)Randi Hernandez
EMD Millipore will provide process development services for Precision Biologics’ preclinical monoclonal antibody.
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EMD Millipore announced on Feb. 2, 2015 that they are providing upstream processing services to Precision Biologics for its preclinical monoclonal antibody NEO-201. The investigational antibody targeting a variant of CEACAM5 and CEACAM6-which has therapeutic potential for the treatment of solid tumors in numerous cancer types including colorectal, lung, ovarian, and pancreatic cancers-will be handled through Millipore’s Provantage service offering.
The process development will occur at EMD Millipore’s single-use GMP biodevelopment center in Martillac, France. According to a press release, EMD’s involvement with the project will help speed NEO-201 to market and improve product yield. “EMD Millipore’s experts will develop an efficient, effective and robust manufacturing process to help reduce the time and cost required to bring the drug candidate to clinical production,” a company spokesperson said in an email.
"We are delighted to partner with Precision Biologics, Inc. to support the process development for NEO-201 and its anticipated progression into clinical trials," said Udit Batra, president and CEO of EMD Millipore, in the release. "Our Provantage team is committed to developing an efficient, effective, and robust manufacturing process to help reduce the time and cost required to advance this important preclinical drug candidate into the next phase for clinical production."
In addition to process development, EMD Millipore’s Provantage services also include process validation, equipment qualification, and GMP production.
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