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.
Biotech Cleanroom Industry Articles
Celerion Expands Early Phase Clinical Pharmacology Units
Celerion, a clinical research organization (CRO) to the biopharmaceutical industry, has announced completion of additions to its research capacity and services
CARsgen Therapeutics launches 37,000-ft cleanroom facility for clinical and early-stage commercial manufacturing
CARsgen Therapeutics 37,000-ft facility for clinical and early-stage commercial manufacturing was designed and built in just 12 months.
Ecolab Opens Healthcare Advanced Design Center to Drive Innovation for the Medical Device Industry
Ecolab Inc., the global leader in water, hygiene and infection prevention solutions and services, is opening the Ecolab Healthcare Advanced Design Center in Eagan, Minn.
Picocyl Expands Product Line and Production Capacity as Demand for Pico-Cylinders Soars
As new and novel drug therapies are developed to address areas where conventional medicines are limited, drug delivery innovators, designers and manufacturers have turned to Picocyl for its unique, patented power solutions for drug and implant delivery systems.
Tonix Pharmaceuticals Announces Groundbreaking Ceremony for Massachusetts R&D Facility to House the Advanced Development Center (ADC) for Vaccine Programs
Tonix Pharmaceuticals Announces Groundbreaking Ceremony for Massachusetts R&D Facility to House the Advanced Development Center (ADC) for Vaccine Programs
Berry Global Unveils the United States’ First Comprehensive, Commercial-Scale Clean Room for Nine-Layer Blown Film Manufacturing
The ISO 7 class clean room can produce nine-layer blown film. The new installation fully encloses commercial-scale production of Berry’s proprietary nine-layer blown film from extrusion to packaging, a first in the United States. The addition further enhances Berry’s ability to supply more sensitive applications such as sterile intravenous solution bags, pharmaceutical packaging, medical equipment manufacturing, and microchip packaging.
Foxx Life Sciences Celebrates Major Expansion
Foxx Life Sciences celebrates two new manufacturing facilities in Londonderry, New Hampshire and Hyderabad, India.
Marker Therapeutics Announces Opening of New cGMP Manufacturing Facility
Marker Therapeutics, Inc., a clinical-stage immuno-oncology company specializing in the development of next-generation T cell-based immunotherapies for the treatment of hematological malignancies and solid tumor indications…
Exyte Builds First ExyCell® Facility in Shanghai
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 Increases Commercial Manufacturing Capacity
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 Received Commercial Manufacturing License from German Health Authorities for its German Drug Product Facility
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.