Kansas-Missouri’s $34 million will translate biologic discoveries into U.S. production, while Virginia’s $16 million will develop and scale pharmaceutical manufacturing.
The collaboration has produced 20 AAV8 manufacturing batches, including 18 under cGMP conditions, supporting pivotal clinical development and future commercial-scale production...
The companies will apply automated manufacturing and quality control technologies to support development of an investigational gene-edited therapy for Friedreich’s ataxia.
The completed program established manufacturing processes and analytical methods to support future GMP production of an investigational Huntington’s disease therapy.
Despite significant budget and headcount reductions at the U.S Food and Drug Administration (FDA), the agency has recently unveiled several initiatives meant to streamline regulations...
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The draft guidance allows developers to leverage chemistry, manufacturing and controls data, as well as nonclinical and clinical information from other relevant products.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.
AI is helping life sciences manufacturers improve uptime, PM effectiveness, calibration planning, and reliability analysis. See where practical AI adds value in GMP asset management...
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.
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.
