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.
The investment at the CDMO’s sites in Aarau and Neuland, Switzerland will support the production of a drug linker for a commercial antibody-drug conjugate.
The new facility will be built at Schott’s existing Lukácsháza site, bringing over 100 additional jobs to the region as it targets the diabetes and obesity markets.
The Maryland lab will support development of alternative and novel synthetic methods to produce active pharmaceutical ingredients and starting materials, among other efforts.
The goal of the teaming is to help accelerate the RNA production process and make life-saving therapeutics and vaccines more accessible to patients globally.
Under the agreement, Agenus’ two biologics facilities in California will be transferred to Zydus for an upfront $75 million payment and $50 million in potential payments.
Fujifilm Diosynth Biotechnologies, now Fujifilm Biotechnologies, offers CDMO services from preclinical to commercialization for biologics, advanced therapies and vaccines.
The biotech company has selected Sterling Pharma Solutions to produce cGMP-quality material for Phase 1 clinical trials of its antibody-drug conjugate KIVU-107.
The companies have partnered to accelerate the adoption and validation of rapid mycoplasma detection methods in cGMP manufacturing for cell and gene therapies.
The CDMO said it will install a new AST GENiSYS C automated vial, syringe, and cartridge line over the next year due to strong demand for its drug product services.
The expansion aims to provide commercial-scale production capacity for a 21-valent pneumococcal conjugate vaccine candidate jointly developed with Sanofi.
The agreement initiates a technology transfer process to Minaris’ GMP facility in Allendale, New Jersey, supporting BrainStorm’s readiness for trial execution.
The regulator rejected the company’s Biologics License Application and requested additional data related to Chemistry, Manufacturing, and Controls (CMC).
The move comes as demand for peptide and oligonucleotide therapeutics continues to accelerate, particularly in light of projected growth in the obesity drug market.
