The agreement covers technology transfer, process development, scale-up, validation, commercial manufacturing, and long-term supply across multiple markets.
The latest updates include shopfloor, data, and warehouse management capabilities intended to improve operator guidance and traceability for individualized therapies.
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Branded a “Chinese military” company by the Department of Defense, the CRDMO secured a legal victory last week against the 1260H designation, but the damage is done.
Proponents say using fermentation processes can help reduce America’s reliance on China and India for key starting materials and active pharmaceutical ingredients.
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.
Private equity group Apax Funds will buy Gerresheimer’s 15 manufacturing sites for primary plastic packaging in nine countries and Centor’s U.S. production site.
CEO Marc Casper says the company’s DynaDrive single-use bioreactor platform is becoming the “favored” technology for efficient, scalable bioproduction.
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The draft guidance allows developers to leverage chemistry, manufacturing and controls data, as well as nonclinical and clinical information from other relevant products.
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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
In response, Scholar Rock will remove the Bloomington fill-finish facility from its Biologics License Application with the agency and rely on a third-party provider.
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.
Germany is at the greatest commercial risk from Washington’s onshoring policies that may trigger tariff and non-tariff measures, warns the data and analytics firm.
The agency wants to increase the fee starting in fiscal 2028 for all foreign API, finished dosage form, and contract manufacturing organization facilities.
Kansas-Missouri’s $34 million will translate biologic discoveries into U.S. production, while Virginia’s $16 million will develop and scale pharmaceutical manufacturing.
