The site, which is expected to be ready for media fill by the end of 2029, is meant to strengthen the CDMO’s aseptic manufacturing capabilities in early clinical development.
The expansion in Plano includes 5,000 square feet of new laboratory space and doubling its Good Manufacturing Practice production capacity for early clinical trial supply.
The partnership between the biopharma company and CDMO is expected to improve yield and upgrade analytical methods ahead of clinical use and regulatory submissions.
The new site precedes the opening of a Yokohama manufacturing facility slated to be operational in 2027 with services for biologics, cell therapies, and messenger RNA.
The site in Hopewell will now incorporate an additional 26,000 square feet of drug substance manufacturing suites, laboratories, storage, dispensing and warehousing.
The CDMO is entering the advanced therapy manufacturing space with the installation of its third FlexFactory platform from Cytiva to meet demand for genomic medicines.
The collaboration seeks to innovate Treg and TIL therapies for autoimmune and solid tumor diseases, streamline workflows, and enhance manufacturing efficiency.
J&J looks to develop end-to-end automated platform for autologous CAR-T cell manufacturing, while Thermo Fisher aims for robotic production of cell and gene therapies.
The company claims it is the only CDMO with BFS capabilities for both biologics and small molecules from early phase development through to commercialization.
The Minnesota CDMO said it will support the advancement of an unnamed customer’s novel ophthalmic therapeutic through clinical development and to market.
The study found that using the company’s Accelerator Drug Development platform from Phase I through Phase III can shorten development by up to 34 months.
The facility expansion in Devens will help support growing demand for antibody-drug conjugates and add up to 70 new jobs when the new capacity comes online in June 2026.
The Belgium-headquartered biopharma company is expanding its footprint, while boosting its partnerships with U.S.-based contract manufacturing organizations.
The turnkey offering includes antibody-drug conjugate and bioconjugation, linker-payload manufacturing, drug product formulation development, and fill-finish capabilities.
A PDUFA decision is expected by June 28. The company is seeking approval of oxylanthanum carbonate for hyperphosphatemia in chronic kidney disease patients on dialysis.
The teaming combines AI-powered protein manufacturing with advanced drug delivery technologies aimed at accelerating timelines and improving therapeutic outcomes.
Working with partner AstraZeneca, the French pharma giant has tripled production capacity and doubled the number of manufacturing sites since the launch of Beyfortus in 2023.
The company is scaling its logistics infrastructure at sites in Tennessee and the Netherlands to meet growing demand for injectable and biologic drug products.
