ABL, Inc. Launches Virus Manufacturing Operations in Europe
Rockville, MD – February 18, 2016 – ABL, Inc. (ABL), a contract research and manufacturing organization to the biopharmaceutical industry, is pleased to announce the opening of its GMP virus manufacturing facility in Strasbourg, France. The 1,500 m2 facility produces live virus-based gene therapies, oncolytic therapies and vaccines on a contract basis for clinical and commercial supply in accordance with both U.S. and E.U. Good Manufacturing Practices (GMPs).
With this manufacturing plant now on-line, ABL establishes itself as a premier global CMO for the production of virus-based therapies and vaccines, providing our clients with increased capacities, improved responsiveness and greater schedule flexibility. Operated by ABL Europe, a wholly owned subsidiary of ABL, Inc., the facility offers bioreactor and adherent production platforms for BSL2 virus seed lots and bulk drug substance and maintains an isolator-based fill-finish line for vialing up to 10,000 doses of live virus drug product per lot. Multiple laboratories associated with the facility house assay development and qualification teams supporting cell-based and compendial lot release and stability services.
Together with virus and protein production in its GMP facility in Rockville, MD, USA, ABL is now able to provide its clients with a single source for a comprehensive contract manufacturing program in Europe and the US for process development, clinical production and commercial supply of vaccine and therapeutic products.
Patrick Mahieux, Pharm.D., General Manager of ABL Europe commented, “The manufacturing and quality staff at the Strasbourg facility have been producing GMP virus products for years for both internal and external projects. We are working with ANSM to complete facility certification of our pharmaceutical manufacturing operations, demonstrating our readiness and commitment to provide the highest quality product for our clients’ vital clinical programs. Our location, near the centers of the biopharmaceutical industry in Europe, affords clients access to a veteran workforce within convenient traveling distance – a powerful combination to consider when making strategic outsourcing decisions.”
Thomas VanCott, Ph.D., President and CEO of ABL, Inc. added, “We have seen a consistent increase in demand for the production of virus-based products in recent years. Innovators from industry and the government sector require partners that can provide diverse skill sets to match the challenge of developing a wide range of novel products. I am especially excited at the prospect of adding new offerings to ABL’s service lines such as large-scale, live virus filling in an isolator environment. This capability is something that our client-base have been asking for and have been telling us for years is underrepresented by the contracting industry.”
Dr. VanCott continued, “The established ABL Europe staff bring extensive experience in virus production, development, and QA/QC. They will prove an immediate benefit to our global client base, and I am extremely pleased to welcome them as a valuable addition to the ABL family.”
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.