Thermo Fisher’s pharma services business benefits initially from policy and tariff impacts, as domestic investment in existing and new facilities ramps up, he contends.
The new business will provide development and manufacturing services for complex small molecules, including HPAPIs, peptides, ADC payloads, and linkers.
Discover how shaft movement, equipment design, and platform stability impact mixer seal performance in pharma and specialty chemical applications — and what modern sealing technologies...
This webinar will examine how Altruist Biologics’ fully characterized, mature membrane chromatography platform addresses challenges around process robustness, scalability, product...
This webinar will highlight green practices, waste reduction efforts, water conservation, evolving regulations, and emerging trends as the industry looks to mitigate its environmental...
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.
What needs to be taken into consideration when scaling up from the laboratory to full-scale production? Matt Smith, Sales Director at Silverson Machines explains which key factors...
Five teams will create automated platforms capable of producing RNA-based genetic medicines and performing quality control testing at or near the point of care.
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The draft guidance allows developers to leverage chemistry, manufacturing and controls data, as well as nonclinical and clinical information from other relevant products.
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 CRL relates to Good Manufacturing Practice observations at third-party manufacturer NerPharMa, and a request for additional commercial-scale consecutive batch data.
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 drugmakers pledged to invest $19.6 billion collectively in U.S. manufacturing and provide discounts on select medicines in exchange for tariff exemptions.
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.
Worker inspects equipment inside pharma facility
