Recent site upgrades, acquisitions, and new partnerships demonstrate a shift from cost-driven outsourcing to integrated, locally anchored models, says the firm.
The CRDMO added 70,000 square feet to the facility and isolated filling lines for syringes, cartridges, and vials, as well as lyophilization/packaging capabilities.
The CDMO’s Texas facility has supported six client programs expected to reach Investigational New Drug submission this year, following its 100th GMP batch in July.
The agreement with a global pharmaceutical company covers technical transfer activities for a marketed injectable product and is expected to begin generating revenue in 2028.
The 3,500-square-meter Vilnius facility includes up to 20 independent cGMP manufacturing lines for cell therapies and personalized medicines, according to the CDMO.
This webinar will highlight green practices, waste reduction efforts, water conservation, evolving regulations, and emerging trends as the industry looks to mitigate its environmental...
The pharmaceutical packaging market is poised for robust growth, fueled by the demand for safe, convenient, and sustainable solutions. Smart and active packaging technologies ...
Learn how oxygen-enriched biological treatment helps pharmaceutical manufacturers unlock up to 50% additional wastewater treatment capacity, improve oxygen transfer efficiency...
Pharmaceutical construction projects face rising delays and costs. Learn how early supplier engagement, smarter coating strategies and expert field support can protect schedules...
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.
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The draft guidance allows developers to leverage chemistry, manufacturing and controls data, as well as nonclinical and clinical information from other relevant products.
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.
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.
dreamstime_xxl_446247687
