ABL Increases Aseptic Fill/Finish Capacity with State-of-the-Art, Fully Automated Vial Filling Line
ABL, Inc. (ABL), a leading contract research, development and biomanufacturing organization to the biopharmaceutical industry worldwide, is proud to announce the successful expansion of its aseptic fill/finish operations at its Rockville, MD GMP biomanufacturing facility with the installation of a new, fully automated vial filling system.
ABL’s new filling line was specifically selected by ABL to meet the needs of its clients developing innovative biologics, namely vaccines, gene therapies, oncolytic live virus-based therapies, monoclonal antibodies and recombinant proteins. The fill line can accommodate lot sizes from 100 to 5,000+ vials, with minimal product loss. The system utilizes a disposable product contact path to limit cross contamination and is contained in a RABS (Restricted Access Barrier System) to increase sterility assurance level (SAL) and prevent the chance of random contamination by operator intervention.
Ms. Beth Tebeau, Vice President of Manufacturing, stated, “The addition of ABL’s new fully automated aseptic fill and finish line for high value biologics, including gene therapies, such as AAV, and live virus vaccines, takes ABL to the next level in terms of serving our clients’ and the market’s growing needs.”
In addition to its Rockville operations, ABL maintains an isolator-based fill/finish line in Strasbourg, France capable of filling live virus products at 10,000 vials per lot. Reservations for new projects at both sites are currently being scheduled for the 3rd and 4th quarters of 2017.
ABL is committed to providing the best solutions and technologies to meet the challenging and ever evolving needs of its clients. To this extent ABL has continued to expand its CMO operations, capabilities and capacity and has invested millions of dollars in the last two years, acquiring a GMP biomanufacturing facility in Strasbourg, France, adding additional upstream and downstream process capacity in Rockville, installing and qualifying the new fill line in Rockville and is currently expanding the Strasbourg GMP facility with the addition of new biomanufacturing suites and single use bioreactors. This commitment to providing the best services to its clients is what has led to ABL becoming recognized as one the leading biologics CMOs globally. In 2017, ABL has already been a finalist for Best Contract Manufacturing Organization (CMO) and Life Sciences Company of the Year awards.
ABL, Inc. is a global biomedical contract research and biomanufacturing organization dedicated to advancing therapeutics, vaccines and other biologic products. ABL maintains GMP facilities meeting U.S. and European regulatory standards, providing process and assay development, cGMP manufacturing of bulk drug substance, cGMP aseptic fill and finish of drug product, and QC bioanalytical testing. Our U.S. and European immunobiology laboratories support clients’ preclinical and clinical sample processing and testing needs. ABL is a part of the Institut Mérieux, a group of companies dedicated to developing translational science for better patient care globally. For more information visit www.ablinc.com or email us.
About ABL Europe
ABL Europe is a wholly owned subsidiary of ABL and encompasses a GMP biomanufacturing facility near Strasbourg, France. In addition to ABL’s GMP contract biomanufacturing facility in Rockville, ABL Europe supports clients’ diverse and growing drug substance and fill/finish needs. The Strasbourg site is capable of filling up to 10,000 vials per batch on its isolator based-line for preclinical, Phase I-III clinical trials and can produce commercial product.