ABL Successfully Completes Drug Product Manufacture of Ebola Vaccine for Clinical Trial
Rockville, MD – June 30, 2015 – ABL, Inc. (ABL), a contract research and manufacturing organization to the biopharmaceutical industry, is pleased to announce the successful aseptic formulation and fill of an Ebola vaccine candidate for Emergent BioSolutions Inc. (EMERGENT).
EMERGENT’s Ebola Zaire vaccine candidate, MVA EBOZ, is a live attenuated, replication defective Modified Vaccinia Ankara (MVA)-vectored vaccine anticipated for use in a Phase I clinical trial led by the Jenner Institute in Oxford, England. Formulation, vialing, labeling and packaging of the vaccine drug product was conducted at ABL’s state-of-the-art cGMP facility located in Rockville, MD. Emergent performed proof of concept work and manufactured the MVA EBOZ vaccine candidate at a 200 L scale in an avian cell line. The scalable process has the potential to meet the demand for multi-million doses in a few months.
“The recent Ebola epidemic in western Africa has highlighted the critical need for both rapid vaccine development technologies, as well as an established and responsive manufacturing network that is ‘in place’ with the capability to meet global demand for new investigational candidates against emerging disease and bioterror threats ”, stated Ms. Beth Tebeau, Vice President of Manufacturing for ABL. “ABL’s Phase I/II cGMP operations are designed to meet the needs of its client base, like EMERGENT, with flexible resourcing for small- and mid-scale production based on single-use, disposable platforms.”
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.