Industry News

Funding will support additional orbital manufacturing missions and pharmaceutical development as the company advances microgravity-enabled drug processing.

The Danish pharma company will invest in the CDMO’s capacity, which is expected to increase ALK’s annual output by about 40% to 1.1 billion tablets from the early 2030s.

The new facility will add commercial-scale particle engineering and finished-dose capabilities to Serán’s Bend manufacturing campus.

The 211,000-square-foot addition will add device fill-finish capabilities and combination product manufacturing to the Hillsboro site.

The company has produced its first R&D batches of Exatecan, a starting material, and plans validation batches by year-end, with initial GMP supply targeted for late 2027.

The sterile injectable CDMO has entered into a definitive agreement to be purchased by the middle-market private equity firm by the end of the year.

The expansion includes seven lines at existing locations and three planned for a new commercial facility in Saarlouis, Germany.

The North Augusta project will add 68,000 square feet of commercial manufacturing space and expand upstream peptide synthesis capacity.

The unannounced inspection covered multiple FDA-approved products including monoclonal antibodies, bispecific antibodies, fusion proteins, and enzyme products.

The CDMO was selected by Belgian biopharma company Flen Health to provide process development, scale-up, and GMP manufacturing services for a wound healing product.

The commercial facility in Suzhou passed a Good Manufacturing Practice inspection by the European Medicines Agency with no critical findings.

The partnership will establish a scalable manufacturing process for CanVirex’s lead candidate, targeting advanced solid tumors.

The new site will manufacture small molecule APIs, including the company’s oral GLP-1 Foundayo, and is expected to employ more than 600 people.

The manufacturers have aligned production processes across two GMP sites, creating capacity of up to 1.2 billion oral antibiotic products annually.

The 85,000-square-foot site adds 15 qualified GMP manufacturing suites to the CDMO’s East Coast network and is immediately operational.

The partnership combines device engineering with formulation, analytical, and production capabilities for drug-device combination products.

The companies will evaluate translating GenomeFrontier’s virus-free CAR-T process to Cellares’ automated production platform.

The approval allows the CDMO to begin GMP production of investigational drug products at its 7,000-square-foot Nottingham facility.

The first of the CDMO’s four planned modules is now operational, adding 7,000 liters of reactor capacity for peptide API development and commercial manufacturing.

The multiyear investment will expand over-the-counter production in North Carolina and consolidate commercial and R&D operations at a New Jersey campus.

The 31,000-square-foot facility in East Windsor adds two commercial-scale spray dryers and completes the company’s $100 million U.S. investment.

The agreement will transfer technology to the country for a portfolio of PD-1 inhibitor biosimilars targeting the Middle East and North Africa market.

The system is designed to automate single-use virus filtration during lab-scale and process development work for gene therapy production.

The acquisition of the Lüleburgaz site adds 338,000 square meters of land and capacity for up to 445 million pharmaceutical packs annually.

The new business will provide development and manufacturing services for complex small molecules, including HPAPIs, peptides, ADC payloads, and linkers.

The Wilson facility will manufacture bioprocess equipment and consumables used in biologics, vaccines, and advanced medicine production.

The agreement gives WuXi Biologics access to Transcenta’s intensified continuous bioprocessing platform for CMC development and manufacturing programs.

The program, which is expected to begin in Q4 2026, will transfer and scale eXoZymes’ N-trans-caffeoyltyramine production process at Curia facilities in Spain and Italy.

The agreement extends commitments through 2033, with production to take place at Samsung Biologics’ Songdo site in South Korea.

The global CDMO’s Bend facility will add two PSD-4 spray-drying units, with operations expected to begin in 2029 and more than 80 jobs created.