France: GMP Manufacturing Services Sartorius Stedim Biotech Supports ABL Europe's GMP Capacity Expansion
Sartorius Stedim Biotech has been selected by ABL Europe as its primary supplier of single-use systems. Through a supply partnership the customer has increased and brought online new viral vector manufacturing capacity at its European facility in Strasbourg.
Goettingen/Germany — 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.
The supplier’s end-to-end process solutions in single-use (SU) format support the customer in expanding its existing drug substance capacity, with a fully disposable manufacturing capability for different viral vector product types produced in non-adherent cell lines.
Patrick Mahieux, General Manager of ABL Europe, has considerable experience in virus manufacturing including senior positions at Sanofi, Guerbet and Transgene. He said that the introduction of non-adherent cell culture capacity would complement their existing adherent cell culture viral vector production technologies. According to him, 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.