U.S.-based CDMO, Afton Scientific, is planning a $200 mn expansion of its sterile injection manufacturing facility in Charlottesville, Virginia, that will significantly increase the company’s production capacity for sterile injectables, whilst adding 200 new jobs. As part of the expansion, the company will be able to offer “newer manufacturing technologies,” although a projected completion date is yet to be determined.

Canadian CDMO, OmniaBio, has opened a new commercial manufacturing facility in Hamilton, Ontario, making it Canada's largest dedicated cell and gene therapy site. The commercially-ready facility will utilize AI and automation to deliver comprehensive services from process, analytical and associated AI development, through to commercial manufacturing for their global clients.

The company said the facility will be crucial in helping biotech's to deliver life-saving treatments, with its first client being MEDIPOST’s stem cell therapy, CARTISTEM®, used for treating knee cartilage defects.

Catalent has completed a series of upgrades to its large-scale spray drying unit (GEA PSD-4) at its Boston, Massachusetts, facility. By adding capacity and multi-solvent capabilities, Catalent can now provide enhanced spray-drying services at the site for amorphous solid dispersion (ASD) formulations across late-stage to commercialization projects.

Lorenzo Carletti, president of clinical development and supply at Catalent, noted the importance of ASDs in overcoming the aqueous solubility issues that plague the oral development pipeline, suggesting that between 75-80% of molecules in pre-clinical and clinical development are affected, and require bioavailability enhancing technologies. He added that by adding to the company’s spray drying capabilities, “Catalent becomes the CDMO with the widest commercial-scale bioavailability enhancing technologies.”

BioDuro-Sundia, the U.S. headquartered contract research, development and manufacturing organization (CRDMO), has opened a new kilo laboratory at its R&D campus, located in the Free-Trade Zone of Shanghai, China. Kilo labs provide pilot-scale production and enable scale-up synthesis for drug substance. The company said the investment will further enhance its ability to accelerate more drug candidates from discovery through to preclinical and clinical phases to meet the growing demands of its global partners.

The opening follows closely behind that of a new compound management center at the same site, which enabled the site to store and handle clients’ compounds at the drug discovery phase.

CDMO, Afton Scientific, is investing $200 mn to expand its sterile injectables manufacturing facility in Charlottesville, Virginia to significantly boost production capacity of which will create 200 new jobs. The project aims to strengthen Afton’s position in the sterile manufacturing market and support both current and future clients with enhanced capabilities for high-demand sterile products.

MRNA and lipid nanoparticle manufacturing experts, Vernal Biosciences, have announced the launch of its integrated analytical and QC services for plasmid DNA, mRNA, and lipid nanoparticles, as commercial services for customers’ complex analytical requirements in mRNA medicine development.

Vernal aims to support drug developers in evaluating CQAs and expediting timelines, whilst maintaining high safety and efficacy standards without compromise. Their state-of-the-art facility in Colchester, Vermont, offers access to advanced analytical technologies, including HPLC, UPLC-MS, digital PCR and nanopore sequencing to customers looking to streamline the development process and minimize costs.

Aptar Pharma has announced a 28,500 sq ft expansion to its manufacturing facility in Congers, New York, as it looks to support the growing demand for prescription and consumer healthcare proprietary drug delivery systems in North America. The extension to its existing facilities will enhance cleanroom, warehousing, and manufacturing capabilities, supporting Aptar’s products including Unidose Nasal Spray for opioid reversal and neffy, the first and only needle-free treatment approved by the U.S. FDA for the emergency treatment of patients with allergic reactions.

Bora Biologics has recently made a series of strategic moves aimed at better positioning itself to rapidly respond to industry’s evolving demands for capacity, integration, and policy developments - such as the U.S. BIOSECURE Act. As a result, the company is well positioned to capitalize on the growing demand for large-molecule CDMO services and opportunities presented by the growing demand for onshoring and friendshoring.

China-based CDMO, Chime Biologics, has announced plans to significantly expand its manufacturing capacity as it looks to boost its drug substance capacity from 28,000L to 100,000L, with targets to enable the production of 15-20 commercial products.

BeiGene CEO, John Oyler, has announced the opening of a new 42-acre innovation center in Hopewell, New Jersey, which is the culmination of a three-year project costing $800mn, as it expands the Company’s integrated manufacturing and research and development footprint in the U.S. The new facility will expand its biologics manufacturing and R&D capabilities - providing a production capacity of two million vials per year - as the company looks to explore new biologics partnerships and accelerate product launches, such as the PD-1 inhibitor Tevimbra.

Eurofins CDMO Alphora Inc. - has expanded its API capacity with a new manufacturing facility in Mississauga, Canada, as the company looks to better serve their growing client base and address increasing demand for life-saving therapies from Phase 1 to commercialization. The 15,000 sq.-ft. facility enhances the company’s existing capabilities with additional GMP processing and warehousing space that will support API batches up to 125 and handling of Safebridge Class 3 compounds.

South Korean CDMO, Lotte Biologics, has acquired land in Songdo, South Korea, to construct three biomanufacturing plants to increase production capacity to 360,000L, and in the process is expected to create 37,000 jobs.

CordenPharma has announced that it is investing €900 mn (c.$982 mn) over the next three years to expand its peptide manufacturing capacity in the U.S. and Europe, driven by rising demand for GLP-1 drugs. The Swiss CDMO plans to build a third facility and add new manufacturing lines to its Boulder, Colorado site, and construct a new large-scale manufacturing facility elsewhere in Europe.

A recently published report from Future Market Insights highlights significant potential for global CMO/CDMO market growth; with projections suggesting a significant increase in value from $22.5 bn in 2023 to $39.4 bn by 2033.

Bora Pharmaceuticals, the Taiwan listed CDMO with a growing U.S. network, has announced an agreement to acquire Emergent BioSolutions’ sterile manufacturing facility in Baltimore-Camden, Maryland.

Since breaking ground in October 2022 and fresh from its IPO in September 2023, SCHOTT Pharma, the maker of drug containment solutions and delivery systems for injectable drugs, announced the culmination of a EUR 76 million investment with the opening of its new production facility in Lukácsháza, Hungary.

A new report suggests that the global sterile injectable CDMO market is projected to reach $33.7 bn by 2034, driven by high demand for biologics, accelerated development timelines, and the shift towards end-to-end business models offering comprehensive services from API development to drug manufacturing.

Simtra BioPharma Solutions, the new name for Baxter International’s BioPharma Solutions (BPS), announced last week that work had started on constructing a 150,000 square foot extension to its facility in Bloomington, Indiana.

Despite its parent company facing scrutiny and potential sanctions from the U.S. government, WuXi AppTec continues to expand its contract research, development and manufacturing organization (CRDMO) services in its native China.

Reflecting Singapore's growing status as a hub for Asia’s biopharmaceutical industry, Novartis has announced a $256 million expansion of its antibody manufacturing facility on the Malay peninsula.