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Nucleus RadioPharma makes Artbio’s radiopharma assets; Minaris manufactures bluebird’s Lyfgenia 

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Welcome to Endpoints News’ manufacturing briefs, where we bring you essential news on new builds, collaborations, recalls and more.

CDMO Nucleus RadioPharma is partnering with clinical-stage company Artbio to manufacture its radiopharma therapy AB001, which is in Phase 1 and 2 trials for prostate cancer, according to a Tuesday announcement. Nucleus will make Artbio’s lead-radiolabeled therapies in Rochester, MN, and use Artbio’s technology, dubbed AlphaDirect, to isolate lead from raw materials.

Cell and gene therapy manufacturer Minaris Regenerative Medicine has completed the first commercial run of bluebird bio’s gene therapy Lyfgenia for sickle cell disease, the company said Wednesday.

Catalent and Siren Biotechnology are partnering to develop the biotech’s adeno-associated virus immuno-gene therapies. Catalent will manufacture in Baltimore, MD, a Wednesday press release said.

Packaging manufacturer Sharp is expanding its site in Macungie, PA, to increase capacity for pre-filled syringes, autoinjectors and vial labeling. The extension adds 157,000 square feet to the site, according to a Monday press release.

Swiss biotech ExcellGene and US-based CDMO Cytovance Biologics are partnering so that the manufacturer’s clients can access ExcellGene’s transposon technology and Chinese hamster ovary and human embryonic kidney cell lines for its clinical and commercial services, the companies said Wednesday.

Service provider Akoya Biosciences has opened its Operations and Manufacturing Center of Excellence in Marlborough, MA, to make Akoya’s molecular barcoded antibodies and reagents, the company said Monday.

Sterile injectable manufacturer Grand River Aseptic Manufacturing is building a new syringe and cartridge filling center, which will be located next to its finishing and warehouse center in Grand Rapids, MI. The company is anticipating the site to be completed in 2025, with new equipment and filing lines added in 2026, the company said Monday.

Wacker Biotech US is expanding its capacity in process development for mRNA, plasmid DNA and recombinant proteins for research and pre-clinical services in San Diego, the company said Monday.

Drug-device combo manufacturer Kindeva Drug Delivery is investing in a second manufacturing line in Loughborough, UK, to make its pressurized metered-dose inhaler products. The manufacturing expansion will be operational in 2026, as per a Monday release.

Akriti Pharmaceuticals has received a non-GMP compliance report from the Malta Medicines Authority after an inspection on April 7 at its site in Saswad, India. The company was found to have three critical, five major and 17 other deficiencies, according to a Wednesday report.

CRDMO Solvias is building a new biotech facility in Research Triangle Park, NC, which will provide services in large molecule analytics, including for cell and gene therapies, antibody drug conjugates and biologics. The company anticipates completing the build in 2025, which will add over 170 new jobs, according to a Monday press release.


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