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.
The funding will support pipeline expansion across biosimilars, innovative medicines, and animal health, as well as development of proprietary rapid-production technologies.
The in-house capability supports an integrated path from DNA to IND submission, eliminating external handoffs for biologics developers, according to the company.
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...
Audit readiness in pharmaceutical manufacturing isn’t just about documentation—it’s built into the physical condition of your facility every day. This webinar reveals how proactive...
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.
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.
To counter the Chinese government’s investment, the U.S. must make a coordinated effort to grow biomanufacturing base, argues a bipartisan commission created by Congress.
The draft guidance allows developers to leverage chemistry, manufacturing and controls data, as well as nonclinical and clinical information from other relevant products.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
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.
The agency cited the CDMO’s significant violations of current Good Manufacturing Practice regulations for finished pharmaceuticals at Simtra’s Halle/Westfalen facility.
