CARsgen Therapeutics 37,000-ft facility for clinical and early-stage commercial manufacturing was designed and built in just 12 months.
The CGMP facility represents a critical first step in a new era of drug manufacturing aimed at strengthening domestic supply chain resiliency
Collected from qualified healthy donors that meet baseline FDA 21 CFR 1271 requirements, industry’s first In Stock GMP-compliant Cryopreserved Leukopaks significantly decrease lead time
ALK Life Science Solutions, a business unit of ALK-Abelló, Inc. (ALK), serving the North American pharmaceutical packaging-based market for glass vials, and UPPI, LLC, the largest association of independent and university-based nuclear pharmacies serving the diagnostic imaging community in the U.S., announced today that they have entered into a three-year partnership to provide high-quality glass vials to UPPI members providing unit dose radiopharmaceuticals and positron emission tomography (PET) manufacturing of radiopharmaceuticals for use in nuclear imaging tests and treatments.
Physician-investigators at Johns Hopkins University Hospital report on the promising data of treatment of COVID-19 induced acute respiratory distress syndrome with allogeneic, cord blood derived T-regulatory (Treg) cell therapy (manufactured by Cellenkos®), published in peer reviewed journal of Annals of Internal Medicine.
Sorrel Medical, a developer and manufacturer of wearable drug delivery devices, today announced the opening of a new manufacturing facility with state-of-the-art cleanroom facilities to accommodate manufacturing scalability of its wearable drug delivery devices.
Grand River Aseptic Manufacturing (“GRAM”), an agile and modern parenteral contract development and manufacturing organization (CDMO), completed its major $60 million expansion project and recently took occupancy.
In line with the increased focus on the medical market segment, Coveris is taking a gigantic leap forward to modernize their medical packaging production facilities. With an extensive EUR 10 m investment program, Coveris strives to become best in class when it comes to process transparency, cleanliness and quality.
Sexton Biotechnologies has announced a new collaboration with BioSpherix Medical. As a tool and technologies partners of the Cell and Gene industry, Sexton and BioSpherix both recognize the need for cost-effective and flexible automation solutions during cell and gene therapy process development. While some upstream bioprocesses have been successfully automated, the final steps of downstream bioprocess, namely Fill-Finish, are often done manually with associated risks of contamination and user error.
Integrity Cleanroom is pleased to announce that it has begun commercial transactions with a brand new ecommerce platform and a dedicated team of professionals based in Texas.
Together these five companies have put together complex build solutions in response to the coronavirus. Individually they were the best for being the fastest of their building type, together they provide the complete solution within weeks, regardless of the requirements. RPM acts as the quarterback pulling in a team of top North American manufacturers with the specific purpose of delivering rapid deployment Community Response Facilities (CRF) that are designed to meet each community’s critical needs. If the location requires conversion of an existing structure, a large building shell that goes up quickly, or mobile secure steel buildings, together we have it covered.
Germfree delivered a 53-foot biocontainment cleanroom trailer to a major US pharmaceutical company where they will work on a COVID-19 vaccine. This is the first, of what is expected to be, many mobile laboratory spaces that will be delivered to scientists and organizations working on virus and antibody testing, vaccine development, research, and deployment solutions.