BioNTech IMFS operates within a state-of-the-art facility providing a unique combination of GMP and BSL2 laboratories.
Manufacturing is performed within thirteen separate cleanroom suites classified as class A/B (class 100 / ISO 5) and class C suites (class 10.000 / ISO 7) with a total cleanroom capacity of approximately 500 m². All suites are equipped with state-of-the-art equipment and are classified as BSL 2.
This multi-purpose facility enables simultaneous handling of a variety of products according to our customers' needs while avoiding cross-contamination and ensuring the highest quality standards. To cover all aspects from process development to product release, BioNTech IMFS has more than 600 m² of Process Development, and QC laboratories, fully controlled under our quality system.
All laboratories are BSL 2 classified and have been built to satisfy the stringent demands of the biotechnology and pharma industry.
BioNTech IMFS has facility equipment monitoring with automated alarm reporting, HVAC system and uninterrupted power supply for all critical equipment in the clean room and laboratories.
BioNTech IMFS also provides GMP cryo-storage capacity for the cryopreservation of cellular products in a 24/7 monitored cryofacility.
To prepare for further growth in demand for cell and gene therapy products, in particular for CAR-T and T-Cell immunotherapies, BioNTech IMFS will significantly increase its production capacity by doubling cleanroom space and expanding development and quality control areas in a new facility by 2020.
Our cleanrooms are fully equipped with standard cell culture technologies, including cell enrichment and depletion systems, single-use bioreactors of different sizes, multistack manipulators, single use downstream processing systems for continuous flow centrifugation and tangential flow filtrationincubators, microscopes, centrifuges (bags and tubes), plasma extractors, scales and more. Irraditiation device for cellular products and controlled rate freezers are in close proximity of the cleanrooms.
BioNTech IMFS’ QC labs are fully equipped to perform optimal analytical methods to measure identity, stability, purity, safety and potency of our customers’ products. Areas for different analytical methods such as microbiology, molecular biology and cell biology are segregated.
In addition to standard lab equipment our QC lab is equipped with multiple flow cytometers, ELISA plate readers, QPCR and ddPCR systems, automated cell counters, blood composition analysers, metabolite analysers, automated sterility measurement devices, HPLC systems, fragment analysers, imagers and many more.
BioNTech IMFS’ development labs are well equipped to support technology transfers, new process developments as well as the development of analytical methods. The labs are equipped for cell culture and molecular biology work and allow the handling of a variety of different product types such as cell products (primary cell, cell lines, naïve, differentiated or gene modified), viral vector products (producer cell lines and vector supernatants) and ivt mRNA products.
Our development areas are equipped with LAFs, incubators, bioreactors, microscopes, cell separation/enrichment devices, microscopes, centrifuges (bags and tubes), multiple flow cytometers, QPCR and ddPCR systems and many more.