Manufacturing roundup: Symbiosis, BioGrad, Abzena, Eschbach and more
This update includes sterile manufacturing, bio-manufacturing, cell line development and radiopharmaceuticals.
Stirling, Scotland-based contract manufacturing organisation (CMO) Symbiosis has expanded its sterile manufacturing capacity following the successfully qualification of its new FPD 50 Flexicon automated fill/finish line. The firm, which specialises in the sterile manufacture of injectable drug products, said the launch would expand its technical capabilities and capacity at a time of growing demand for high-quality sterile manufacturing. Symbiosis’ sterile liquid fill/finish system will operate under a Grade A Restricted Access Barrier System (RABS) that incorporates rapid transfer ports for aseptic handling and high-accuracy vial filling with flexicon pump technology.
UK biotech company BioGrad has unveiled plans for a new Centre of Bio-Manufacturing Excellence in Liverpool. The GMP-compliant facility will focus on accelerating research into advanced cell and gene therapies, including CAR T-cell treatments. Work on the new centre will begin by the end of the year and, once up and running, BioGrad hopes it will help position the North of England as a leader in advanced CGT and bio-manufacturing.
US CDMO Abzena has expanded its AbZelectPRO cell line development (CLD) platform through a strategic licensing agreement with Massachusetts med tech company Revvity. San Diego-based Abzena has launched two glutamine synthetase (GS) knockout CHO-K1 expression systems, including a double knockout ADCC+ platform for afucosylated proteins. The new GS knockout platforms are available as a standalone CLD offering or as a fully integrated GMP programme and use Revvity’s Chosource platform pairing it with ProteoNic Bioscience’s 2G UNic vector technology.
Process industry software developer Eschbach has launched a new batch tracking solution for its Shiftconnector enterprise manufacturing platform. The Germany-headquartered firm said it would promote seamless collaboration between production, QA and QC teams for a more streamlined batch release process by automatically integrating data from key systems such as the MES, LIMS, ERP and QMS. The new system is GxP compliant, GAMP 5 validation-ready and can support audit trials and digital signatures.
XenoStart has expanded its partnership with the CRO/CDMO Minerva Imaging to launch an integrated platform for radiopharmaceutical drug development that covers discovery, translational research and manufacturing. The oncology collaboration will combine XenoStart’s repository of clinically annotated patient-derived xenograft (PDX) models with Denmark-based Minerva’s molecular imaging and radionuclide therapy capabilities. XenoStart, the preclinical division of the Texas-based Start Center for Cancer Research, said the new platform would deliver “the gold standard in translational oncology research to target cancers such as prostate”.
