Vecura GMP laboratory
Vecura has served as contract manufacturer for more than 10 years and has supplied GMP (Good Manufacturing Practice) grade gene therapy vectors for more than 20 clinical trials in different countries in Europe. More than 250 patients have been treated with vectors produced by Vecura. No adverse effects have been recorded.
Vecura is approved by the Swedish Medical Products Agency as a manufacturer of cell- and gene therapy products for clinical trials. Vecura also holds permit from the Swedish Environment Work Authority for working with adenoviruses and retroviruses including lentiviruses. References are found on our website.
The facility is located in the Novum research park and has a total area of 800 sqm out of which the laboratory occupies 400 sq. m. Adjacent area of 400 sq. m is for quality control, storage, offices and general purpose uses. There are 9 clean room suites. Of these 8 meets B-class and one D-class. All suites are equipped with LAF units. The unit has its own separate ventilation system. The incoming air as well as all outgoing air to the clean room suites passes through HEPA filters (High Efficiency Particle Absorbtion). The HEPA filtered air is exchanged 25 times per hour and the pressures are adjusted accordingly. A monitoring system records pressures and temperatures within the facility and equipment. Novel technologies for large-scale GMP production are under development in the laboratory.
Five production suites are dedicated to manufacturing of cell therapy products. Systems for cell culture at the facility includes the Wave biorector, roller bottle incubator, CellCube and CliniMacs.
The production unit for plasmids consist of a cultivation room with a shaker, a 12 L fermentor and a centrifuge for harvesting and a separate room for preparation of pure plasmids. Filling takes place in an adjacent clean room. Pass-through boxes connect the three rooms.
One suite with a separate lock is designated for work with viruses and infected material. The suite meets BSL2/BSL3 (P2/P3) standards.
Produced products and critical reagents are stored in a separate freezing room equipped with refrigerators, –20oC freezers, –80oC cabinets, –150oC compressor freezers and isothermal freezers. The temperatures in the freezers are monitored by a validated monitoring system.
Quality control (QC)
Includes testing of produced products according to SOPs. This includes FACS analyses.
Vecura has a highly qualified staff consisting of physicians, molecular biologists, cell biologists and engineers. With our broad knowledge and long experience we have the possibility to develop tailor-made production processes according to the customers special demands. Our customers include hospitals, universities, biotech companies and large pharma in Sweden and other European countries.