The U.S. Department of Defense has inflicted substantial reputational, commercial, and operational damage to the China-headquartered CRDMO, according to its lawsuit.
The Bohumil site will initially produce supportive proteins for next-generation diabetes and obesity medicines as part of Novo Nordisk’s global manufacturing network.
The inspection supported EU marketing authorization applications for 19 biologics spanning antibodies, enzymes and fusion proteins from 13 clients, according to company.
The tool is designed to analyze the CDMO’s data to accelerate root cause analysis and corrective action development for deviations and complaints across its network.
The new Florida facility enables coordinated supply of critical in vitro transcription materials from research through commercial-scale RNA therapeutic production.
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...
UV is a comprehensive solution for chloramine reduction and can work synergistically with activated carbon, helping to reduce waste, lower operating costs, and minimize the amount...
Go beyond similarity in this webchat with a Thermo Fisher Scientific expert on how a p-value-based multivariate residual approach verifies pharmaceutical raw materials.
Contract development and manufacturing organizations (CDMOs) are more critical than ever to the biopharmaceutical industry, providing essential outsourcing services to customers...
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.
Industrializing the manufacturing of these complex therapies is critical to ensure scalability and commercial viability, says the Alliance for Regenerative Medicine.
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 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.
The framework for the development and approval of individualized therapies for genetic conditions has significant chemistry, manufacturing, and controls hurdles.
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
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 —...
The pilot, which launched in April, has evaluated 46 facilities using one-day inspectional assessments as the agency looks to make its resources more targeted and efficient.
According to US Pharmacopeia, supply chain reliance on domestic and foreign facilities for everything from materials to final products is creating single points of failure.
The Department of Defense says the China-based contract research, development, and manufacturing organization is indirectly affiliated with the People’s Liberation Army.
