Sodium Zirconium Cyclosilicate

Welcome to Endpoints News’ manufacturing briefs, where we bring you essential news on new builds, collaborations, recalls and more. AstraZeneca has opened its expanded Coppell, TX, facility which makes its hyperkalemia drug Lokelma, the company said Wednesday. The $445 million expansion has doubled the production of Lokelma. Avidity Biosciences has delayed its biologics license application submission to the FDA for its Duchenne muscular dystrophy treatment called delpacibart zotadirsen, or del-zota for short. It will file in the first quarter of 2026 rather than the end of the year to add extra CMC data for its BLA, it said on Monday. A new CDMO called Codis has launched . The company comes from a merger of US Particle Dynamics and a UK spray drying facility formerly owned by EuroAPI. Codis will focus on commercial spray drying, amorphous solid dispersions and particle engineering tech. It will operate out of three sites in St. Louis, MO, Seymour, IN, and Haverhill, UK. LTS Lohmann Therapie-Systeme has acquired the US-based CDMO Renaissance Lakewood. The transaction is expected to close by the end of November. The Monday release did not give financial details. Nusano will supply radioisotopes, including actinium-225 and lutetium-177, to Ariceum Therapeutics under a new partnership. GC Biopharma has secured contract manufacturing rights for a recombinant shingles vaccine named amezosvatein from Curevo Vaccine. GC Biopharma will be responsible for making some of the commercial supply of the vaccine for global distribution. Amezosvatein is in a Phase 2 study expected to be completed by 2026. Coalition for Epidemic Preparedness Innovations (CEPI) is collaborating with Serum Institute of India to develop a vaccine to target H5N1 bird flu, which will be a prototype for pathogens with pandemic potential, the companies said Monday.

AstraZeneca announced the completion of its newly expanded manufacturing facility in Coppell, Texas, which will double production capacity for its potassium binder Lokelma, the company said. The $445 million investment includes the addition of a new 9,000-square-foot building that will house two new manufacturing lines, expanded drug substance and product laboratory testing capabilities, warehousing, utilities, and administrative space. Located outside Dallas, the Coppell site serves as AstraZeneca’s sole global manufacturing hub for Lokelma, supplying more than 50 countries. The facility employs over 250 people and has supported local pharmaceutical manufacturing for the past decade, according to the company. The project follows AstraZeneca’s recent groundbreaking of a $4.5 billion manufacturing facility in Albemarle County, Virginia , focused on chronic and metabolic diseases. That site will also produce small molecules, peptides, and antibody-drug conjugates (ADCs) for cancer and weight management therapies, the company said. Together, the Texas and Virginia expansions are part of AstraZeneca’s $50 billion U.S. manufacturing and R&D investment plan announced earlier this year, aimed at strengthening domestic production capacity and accelerating innovation.