Through this investment, the Sligo site will feature Class 7 cleanroom manufacturing environments and state-of-the art thermoforming operations, fully certified to ISO 13485 standards and meeting the highest regulatory requirements.
Celerion, a clinical research organization (CRO) to the biopharmaceutical industry, has announced completion of additions to its research capacity and services
CARsgen Therapeutics 37,000-ft facility for clinical and early-stage commercial manufacturing was designed and built in just 12 months.
Exyte has successfully completed the construction of the first ExyCell® facility in China, the CliniMACS Cell Factory® of Miltenyi Biotec, a global provider of integrated solutions for Advanced Therapy Medical Products (ATMPs). The patented ExyCell technology was developed by Exyte as an end-to-end, integrated facility solution with standardized and modularized elements. These pre-configured and pre-fabricated modules enable fast-track construction thereby shortening time-to-market for new therapeutics and vaccines. The ExyCell facility is installed on the fourth floor of the ATLATL building located in the Zhangjiang High-Tech Park, and Miltenyi Biotec is now transferring production technology from Germany to China with regular operations for ATMP production is expected by autumn 2021. The facility will soon be open to visitors by appointment.
BrainStorm Cell Therapeutics Inc., a leading developer of cellular therapies for neurodegenerative diseases, announced today that is has received Good Manufacturing Practice (GMP) approval from the Israel Ministry of Health for three state-of-the-art cleanrooms…
WuXi Biologics (“WuXi Bio”) (2269.HK), a global company with leading open-access biologics technology platforms, announced that it has received the License of Manufacturing Permit from German health authorities for its drug product facility (DP7) in Leverkusen, Germany. The permit successfully demonstrates for the first time that Premier Quality together with Record Speed WuXi Biologics consistently delivered in China can also be applied in global countries.
Quattroflow, part of PSG and Dover (NYSE: DOV), announced that it will increase manufacturing capacity for its single-use quaternary diaphragm pumps with the construction of a new ISO Class 7 cleanroom.
Expected to open in October 2021, the additional cleanroom will more than double the Quattroflow cleanroom space in Duisburg, Germany.
PAJUNK, a leading global provider of medical devices, moved into its new headquarters, located in Alpharetta, GA, just north of Atlanta. The 50,000 square foot building houses new office space, a state-of-the-art clean room for manufacturing procedural trays, and a 30,000 square foot warehouse. The increased space is designed to keep up with growing demands while providing best-in-class customer service.
Novo Holdings today announced that it has co-led with Vivo Capital the over-subscribed US$200 million Series A and Crossover round in Esco Lifesciences Group (“Esco”), a leading provider of life sciences tools and services. The financing will enable Esco to strengthen its position through organic and external growth and transformation, as well as invest in China, thus addressing some of the most dynamic market segments and geographies. Other investors include two Asian sovereign wealth funds and Singapore-based global investor, EDBI.
Novatek Requalified as an approved supplier for Boehringer Ingelheim, a global leader in healthcare. Novatek regulatory compliant quality solutions is used at Boehringer Ingelheim for its human pharma, animal health and biopharmaceutical aseptic (sterile) manufacturing sites worldwide.
Freudenberg Medical, a global contract design and manufacturing provider to the medical device industry, is expanding its manufacturing operations in Alajuela, Costa Rica. The expansion project adds 8,600 square feet to the existing facility which includes construction of an additional ISO Class 7 cleanroom for catheter manufacturing and assembly, molding, extrusion, and packaging, as well as added office space. New technology includes an advanced thermoplastic extrusion line which can produce tubing from 4 inches to 170 inches long with capacity of up to 1 million parts per month, plus additional injection molding machines.
Prenetics Limited, a global leader in diagnostics and genetic testing, Oxford University and Oxford Suzhou Centre for Advanced Research (OSCAR) have signed multi-million dollar collaboration agreements to further develop the award-winning OxLAMP™ technology, a rapid, molecular testing technology for infectious diseases.