The agreement covers production, quality control, stability testing, and CMC documentation at Bora’s Maple Grove, Minnesota facility to support a Phase 3 clinical trial.
The expansion brings the company’s U.S. investment to more than $1 billion and adds small molecule drug product manufacturing and packaging capabilities.
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Both CRDMOs were accused of ties to China’s government, yet only WuXi AppTec was recently added to the Pentagon list of “Chinese military companies” operating in the U.S.
As global and domestic pressures mount, Japanese drugmakers are looking to improve development timelines, manufacturing execution, and operational efficiency.
Big Pharma and contract development and manufacturing organizations are making large capital expenditures to build infrastructure supporting the wildly popular medications.
The Indian drugmaker reported certain batches were out of specification due to an issue associated with the active pharmaceutical ingredient used in the product.
As priorities evolve, single-use technologies are enabling more flexible facilities, hybrid manufacturing strategies, and the next generation of biopharmaceutical production.
The pharmaceutical giant is leveraging artificial intelligence to scale production and optimize the efficiency of operations to meet high demand for its medicines.
Bureau of Labor Statistics forecasts pharmaceutical manufacturing will add nearly 19,000 production jobs, ranking among the fastest-growing industries.
The integration of chemical engineering into process development has transformed how companies scale, control, and optimize manufacturing for a new generation of therapies.
The draft guidance allows developers to leverage chemistry, manufacturing and controls data, as well as nonclinical and clinical information from other relevant products.
Faced with the increasing complexity of peptide programs, Japan’s drugmakers are turning to outsourcing in preclinical and early stages, contends Neuland Laboratories.
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Software platforms can seamlessly integrate with emerging technologies to unlock efficiencies, strengthen sustainability and enable proactive prevention of disruptions.
Built-in ability to meet data integrity standards should be a central focus when selecting control systems and manufacturing execution systems for pharma manufacturing
As one of seven companies picked for the pilot, the integrated development and manufacturing organization says regulatory engagement cuts commercialization risk.
The agency selected contract manufacturers Cellares and Fujifilm Biotechnologies, as well as Big Pharma drugmakers Eli Lilly and Regeneron, for the pilot’s initial cohort.
The fill-finish facility in Bloomington, formerly owned by Catalent, was cited for eight observations including persistent contamination and quality systems deficiencies.
Industry stakeholders support the agency’s effort to engage manufacturers earlier in facility development, but uncertainty remains on how the program will be implemented.
The legislation aims to increase visibility of foreign supply sources amid what they warn is a “growing foothold” in domestic pharmaceutical manufacturing.
Chinese biopharma companies lead when it comes to manufacturing scale, CDMO capacity, and raw materials, according to analyses from the Cure Innovation Index.
The U.S. Department of Defense has inflicted substantial reputational, commercial, and operational damage to the China-headquartered CRDMO, according to its lawsuit.
