Industry News

Construction of the Saarland facility is scheduled to begin in 2026, with operations expected to start in 2031.

The collaboration covers preclinical pharmacology studies and clinical supply to support planned IND filings in China and the United States.

The financing will support global deployment of the company’s integrated, GMP-ready manufacturing facilities in Europe, Japan, and the U.S.

The move follows the sale of Noramco’s API assets and positions Halo for expanded sterile manufacturing capacity, according to the company.

The collaboration will evaluate GMP-ready robotic systems for scalable, high-throughput cell therapy production.

The $30 million expansion adds 2,000-liter single-use GMP capacity to support late-stage and commercial biologics programs.

The agreement centers on CMC execution and GMP manufacturing support for multiple clinical-stage fusion protein programs.

Manufactured under cGMP conditions, the additions include low-endotoxin and enzyme-free formulations for laboratories and manufacturing use, the company said.

The investment supports compliant manufacturing of non-bacterial beta-lactam medicines amid stricter cross-contamination controls.

The Grissom Aeroplex expansion in Bunker Hill adds GMP capacity for high-volume therapeutic and diagnostic production.

The collaboration, which includes Merck Sharp & Dohme and Hilleman Laboratories, will focus on improving process yield and storage to support scalable vaccine production.

The agreement covers clinical and commercial manufacturing support for Atsena’s inherited retinal disease programs.

The robotic-operated cell processing system is designed to reduce manual intervention while maintaining existing biological workflows, according to the companies.

The collaboration supports early-stage AAV development for a rare inherited disorder linked to phosphate regulation.

The multi-year agreement targets orphan and niche therapeutic active pharmaceutical ingredients for regulated and semi-regulated markets.

The new facility in Durham, North Carolina will support expanded analytical and development services for biologics and other complex therapeutics.

The expanded agreement between BMS and the Indian CRDMO broadens integrated discovery, development, and manufacturing services across the drug lifecycle.

The investment adds cold chain storage, syringe and device assembly, as well as GMP packaging capacity in Belgium and the Netherlands.

The Apex, North Carolina facility will operate as an FDA-registered 503B site focused on domestic production of shortage-listed generic injectables.

The agreement aims to integrate affinity-based cell isolation into an automated system to support faster, scalable T-cell processing.

The added GMP-compliant line increases flexibility for oral solid dose packaging as demand grows for scalable bottle formats.

The agreement provides bioconjugate supply for clinical expansion and future commercialization of photoimmunotherapy programs.

A pilot program shows reaction data that can compress active pharmaceutical ingredient process development timelines from years to months, according to the companies.

The UK’s Medicines and Healthcare products Regulatory Agency clears two sites in Wuxi, China, for commercial ophthalmic biologic manufacturing and packaging.

The agreement adds a single-plasmid lentiviral vector manufacturing option at AGC’s Milan cell and gene therapy site.

The acquisition of the Tempe, Arizona facility will expand U.S.-based drug delivery device capacity and support the company’s $10 billion manufacturing investment.

The new Leiden-based facility will serve as European headquarters and support regional cell therapy manufacturing as programs move toward commercial supply.

The new facility in Winter Park, Florida aims to optimize delivery of cancer treatments across the southeastern United States.

The integrated platform combines cell line development, process development, and GMP support for early clinical programs.

The agreement gives Sidewinder access to a site-specific ADC platform to support development of next-generation bispecific antibody-drug conjugates.