ABL Recognized for Supporting Fill-Finish of Novavax’s Zaire Ebolavirus Glycoprotein Nanoparticle Vaccine
Rockville, MD – February 13, 2015 – The release of Novavax’s Zaire ebolavirus (EBOV) vaccine within three months from project initiation is described in BioProcessing Journal’s Spring 2015 article “Rapid Manufacture and Release of a GMP Batch of Zaire Ebolavirus Glycoprotein Vaccine Made Using Recombinant Baculovirus-Sf9 Insect Cell Culture Technology” (BioProcessing Journal, Hahn, Timothy, et al.). Novavax applied its platform technology to carry out this accelerated development program as part of the effort to address the current EBOV outbreak. ABL was selected to perform cGMP aseptic vialing, visual inspection, labeling and packaging of four lots of the final dosage form. ABL worked closely with Novavax, meeting critical response times with flexible resource and facility utilization; delivering final drug product and full supporting documentation on time and within budget. The EBOV/Mak GP nanoparticle-based vaccine candidate is planned for use in a Phase I clinical study.
About ABL, Inc.
ABL, Inc. is a global biomedical contract research and manufacturing organization dedicated to advancing vaccines, therapeutics and other biologic products. ABL has extensive experience working with diverse organizations, including the U.S. Government, biopharmaceutical companies and academic entities. Notable contract manufacturing services include process and assay development, cGMP biologics manufacturing of bulk drug substance, cGMP aseptic fill and finish of drug product, and QC analytics in the U.S. and Europe. ABL also maintains U.S. and European immunological and molecular laboratories to support preclinical and GCLP clinical sample processing and testing. ABL is a part of the Institut Mérieux, a group of companies dedicated to developing translational science for better patient care globally.