Sartorius Stedim Biotech S.A. (SSB), a leading international technology partner of the biopharmaceutical industry, has been selected by ABL Europe as its primary supplier of single-use systems. Through a supply partnership with SSB, ABL Europe has successfully increased and brought online new viral vector manufacturing capacity at its European facility in Strasbourg. A subsidiary of ABL Inc., ABL Europe provides dedicated viral vector GMP manufacturing services for oncolytic, vaccine and gene therapy projects in all stages of clinical development through to commercial launch.
Sartorius Stedim Biotech has delivered a comprehensive GMP viral vector manufacturing package solution that includes single-use bioreactors and an automation platform for normal flow filtration, tangential filtration and mixing. These have been installed at the facility, which is now in the process of manufacturing batches of viral vector products for ABL’s clients. Sartorius Stedim Biotech’s end-to-end process solutions in single-use (SU) format have helped ABL expand its existing drug substance capacity, with a fully disposable manufacturing capability for different viral vector product types produced in non-adherent cell lines.
Amélie Boulais Raveneau, Vaccine Platform Marketing Manager at SSB, commented: “We’re very proud to have been selected by ABL Europe to supply single-use process technologies and analytics specifically designed for use throughout ABL’s viral vector manufacturing process train. It is a significant endorsement of SSB’s platform for viral vector processing and the singleuse design capabilities of the Sartorius Integrated Solutions engineering team. Our process development consultants share their expertise with clients to ensure optimal implementation of our technologies and overcome challenges in viral vector applications.”
Patrick Mahieux, General Manager of ABL Europe, has considerable experience in virus manufacturing including senior positions at Sanofi, Guerbet and Transgene. He said, “The introduction of non-adherent cell culture capacity complements our existing adherent cell culture viral vector production technologies. It is the only pure-play, dedicated viral vector production site capable of manufacturing drug substance and drug product materials for toxicological studies, all clinical phases and even commercial launch. Everything from process development, manufacturing and QC release testing is performed under one roof.”
To learn more about the facility, visit: https://vimeo.com/246296559.
About Sartorius Stedim Biotech
Sartorius Stedim Biotech is a leading international supplier of products and services that enable the biopharmaceutical industry to develop and manufacture drugs safely and efficiently. As a total solutions provider, Sartorius Stedim Biotech offers a portfolio covering nearly all steps of biopharmaceutical manufacture. The company focuses on single-use technologies and value-added services to meet the rapidly changing technology requirements of the industry it serves. Headquartered in Aubagne, France, Sartorius Stedim Biotech is quoted on the Eurolist of Euronext Paris. With its own manufacturing and R&D sites in Europe, North America and Asia and an international network of sales companies, Sartorius Stedim Biotech has a global reach. In 2017, the company employed approx. 5,100 people, and earned sales revenue of €1,081.0M.
About ABL Europe
ABL Europe, a subsidiary of ABL, Inc. under the corporate ownership of Institut Mérieux, offers clinical and commercial scale GMP manufacturing of viral vectors for supply of gene therapy, oncolytic and vaccine products for use in all stages of product development globally. From its state-of-the-art GMP facility located in Strasbourg, France, ABL Europe's aseptic processing capabilities for drug substance and drug product, includes stirred single use bioreactors (SUB) < 500 L, adherent capacity in roller bottles or cell stacks < 90 m2, and automated filling using a rigid isolator < 10,000 vials per batch. ABL Europe is collaborating with an expanding client base supporting projects in phase 1/2 development, in addition to providing process validation and product supply for phase 3 / pivotal efficacy studies.