As one of seven companies picked for the pilot, the integrated development and manufacturing organization says regulatory engagement cuts commercialization risk.
The investment will modernize the company’s API manufacturing site to support growing demand for U.S.-based CDMO services and increasingly complex drug substances.
The mobile maintenance platform will be deployed across the company’s global manufacturing network following a successful implementation at its production site in Spain.
The connected manufacturing environment is meant to enable manufacturers to scale production to commercially viable levels without replacing existing processes.
The expanded collaboration adds commercial-compliant packaging and distribution for MCO-010, an optogenetic gene therapy targeting retinal degenerative diseases.
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...
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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 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.
While the biologics market is experiencing strong growth, particularly antibody-drug conjugates, it also poses significant production challenges for the industry.
The proposal also includes $9 million and 19 new full-time positions for the U.S. Food and Drug Administration to accelerate advanced pharmaceutical manufacturing.
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The draft guidance allows developers to leverage chemistry, manufacturing and controls data, as well as nonclinical and clinical information from other relevant products.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
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.
Cell therapies in the U.S. operate within an evolving FDA regulatory playbook that is grounded in the long-standing drug GMP framework — 21 CFR Parts 210 and 211 —...
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.
The China-headquartered CRDMO filed a complaint with the U.S. District Court for the District of Columbia challenging the designation by the Defense Department.
