CEO Ulrich Faessler called the U.S. investment a “major step forward” in positioning SHL as the only autoinjector manufacturer operating across three continents.
Brazil, Russia, India, China, South Africa (BRICS) members are positioning themselves to offset the pressures from U.S. trade policies, says analytics firm GlobalData.
While Canada is not the largest supplier of U.S. pharmaceuticals, proposed tariffs could significantly increase costs and disrupt supply chains, according to a new analysis.
Customers using Cellares’ automated cell therapy manufacturing services will receive priority review from the agency, leading to accelerated regulatory filings.
The courier, providing logistics services for clinical trials, biopharma, and cell and gene therapies, operates in 15 countries and handles over 600,000 shipments per year.
The nuclear medicine company has completed its purchase of Turkey-headquartered Monrol, with plans to significantly expand capacity for the medical isotope Lutetium-177.
The 100,000-square-foot facility currently offers 4,000 pallet positions for storage at +15-25°C, with plans to add capacity for -20°C and +5°C storage by late 2025.
The CDMO will scale up capabilities at its 190,000-square-foot Blue Ash site to support device assembly, packaging, and increased cold/ambient storage for drug products.
The potential tariff impacts on the two biotechs is based on manufacturing footprints outside the U.S. and tax benefits from overseas operations, the analysts said.
A Biotechnology Innovation Organization survey also found nearly 90% of U.S. biotech companies rely on imported components for at least half of their FDA-approved products.
The Chinese CRDMO credited last year’s growth, in part, to the utilization of existing and newly expanded capacities including the ramp-up of manufacturing sites in Europe.
The certification permits the company to manufacture and release both clinical and commercial sterile drug products from its facility in Saint-Beauzire, France.
Plant and animal biotech will contribute $56 billion to the U.S. economy by the end of the decade, predict the Biotechnology Innovation Organization and Kearney.
The company said the regulatory approval secures reliable and consistent supply of Contrave, more than doubling its capacity to produce the medication.
Renovations to the Quebec site, which produces 20 of the 100 critical medicines essential to Canada’s healthcare system, will include a new filling line.
The CRDMO is among five Chinese contract manufacturers targeted by the proposed U.S. legislation. WuXi AppTec said there is no proposal in Congress to re-initiate the bill.
In Poland, the company has quadrupled its capacity for manufacturing, formulating, and filling USP purified water and Water for Injection-based hydration solutions.
The Glasgow site, known for its work in antibody-drug conjugates, lipid nanoparticles, and complex formulations, will see its batch capacity increase to 20,000 vials.
Lifecore will oversee the technology transfer of the drug’s fill-finish process, conduct gap assessments, and provide a pilot batch as part of the collaboration.
The partnership integrates Asimov’s CHO Edge platform, which uses synthetic biology and AI to optimize Chinese hamster ovary cell lines for antibody and protein production.
Plant 5 will be operational in April and the CDMO is moving forward with plans for the construction of Plant 6 to “maintain the world’s No. 1 manufacturing capacity.”
CEO Greg Behar said recent investments and partnerships have significantly expanded the global CDMO’s capacity in key areas such as pre-filled syringes and lyophilization.
