Manufacturing

A new method developed by the NIH bypasses genetic RNA extraction, simplifying the testing process.

BlackBerry’s QNX real-time operating system may create cybersecurity vulnerabilities, according to FDA.

The Cleveland, Ohio facility will produce critical anti-infective drug products for US hospitals.

Artiva Biotherapeutics’s new R&D and GMP manufacturing center in San Diego, Calif., for NK cell therapies is expected to open in 2022.

Thermo Fisher’s manufacturing site in Greenville, NC was recognized for manufacturing excellence.

Syngene’s additions include a new microbial facility and an expanded mammalian facility.

Primates inoculated with CV2CoV show improved immune response and protection from various COVID variants.

Biotage’s new facility in Cardiff, UK, will produce lipids using large-scale flash purification.

Mechanistic models provide process understanding for developing robust manufacturing processes and for scale up and tech transfer.

PNI expands global headquarters with a new 75,000-square-foot facility, which will include multiple GMP suites for manufacturing RNA therapeutics and vaccines.

Almac Sciences has signed a manufacturing agreement with Pila Pharma for the production of the API XEN-D0501.

Rentschler Biopharma has broken ground nearby its Milford, Mass., site where it will build its new multi-product manufacturing facility for commercial production of complex molecules.

Lykan Bioscience and Vineti will combine their capabilities to streamline process development and manufacturing to move cell therapies through clinical phases to commercialization.

Recro acquires CDMO IRISYS, establishing a bi-coastal presence in the US.

Consider tactics to meet sustainability objectives for temperature-controlled packaging.

A research team at the Keck Graduate Institute will work to adapt its decade-long low-cost vaccine R&D for developing countries into a COVID-19 vaccine.

A collaboration between Aldevron and Ginkgo Bioworks has resulted in a manufacturing enhancement that can improve production of an enzyme used for mRNA therapeutics.

Veraxa and Indivumed will work together to develop colorectal antibody drugs.

Lonza and Sheba Medical Center have successfully dosed four patients with a CD19 autologous CAR-T cell therapy using Lonza’s Cocoon automated manufacturing platform.

Moderna will build an mRNA vaccine manufacturing facility in Canada to provide access to domestically manufactured vaccines against respiratory viruses.

The Just - Evotec Biologics facility in Redmond, Wash., uses the company’s J.POD technology.

Nobelpharma has come to terms on an agreement to use ProBioGen’s vaccine manufacturing platform AGE1.CR.plX.

Datwyler offers the StarterPack packaging system designed to aid in the development of parenteral drug packaging.

The agency is endorsing recommendations for global track-and-trace systems developed by the International Coalition of Medicines Regulatory Authorities.

Kyowa Pharmaceutical Industry and Bora Pharmaceuticals have announced a partnership to produce generic-drug product for filing in Japan.