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Industry News

The unannounced inspection covered multiple FDA-approved products including monoclonal antibodies, bispecific antibodies, fusion proteins, and enzyme products.
Sept. 25, 2026
The CDMO was selected by Belgian biopharma company Flen Health to provide process development, scale-up, and GMP manufacturing services for a wound healing product.
Sept. 25, 2026
The commercial facility in Suzhou passed a Good Manufacturing Practice inspection by the European Medicines Agency with no critical findings.
Sept. 24, 2026
The partnership will establish a scalable manufacturing process for CanVirex’s lead candidate, targeting advanced solid tumors.
Sept. 24, 2026

Learning Resources

Sponsored
There are a growing number of cloud-based applications, but not all are equipped to meet the quality and control standards required for GxP compliance. Learn how to confidently...
Sept. 25, 2026
Cover image credit: www.dreamstime.com/john6863373_info
Cover image credit: www.dreamstime.com/john6863373_info
Sponsored
Geopolitical and economic uncertainty remain formidable challenges for the pharmaceutical industry, which this year weathered a volatile global business environment. The sector...
Sept. 18, 2026
Sponsored
Discover how shaft movement, equipment design, and platform stability impact mixer seal performance in pharma and specialty chemical applications — and what modern sealing technologies...
Sept. 9, 2026
Sponsored
This webinar will examine how Altruist Biologics’ fully characterized, mature membrane chromatography platform addresses challenges around process robustness, scalability, product...
Oct. 7, 2026

Podcast

Editors' (re)View

Scheduled to tour the company’s flagship “smart factory” in Bridgewater this week, it was called off after losing Bristol Myers Squibb as a customer.
Aug. 26, 2026
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.
Aug. 11, 2026
Proponents say using fermentation processes can help reduce America’s reliance on China and India for key starting materials and active pharmaceutical ingredients.
Aug. 7, 2026
While generic pharmaceutical products made outside the U.S. remain tariff-free for the time being, the rate could be raised to as much as a 200% duty.
July 24, 2026

Production

Researchers are using machine learning and real-time process monitoring to improve bioreactor control and help manufacturers automate manual processes.
Sept. 18, 2026
BMS said the system could not meet requirements to make commercial Breyanzi. Cellares claims it has manufactured GMP drug product in an FDA-regulated clinical program.
Sept. 17, 2026
Sponsored
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...
Sept. 14, 2026
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.
Sept. 2, 2026

Development

As pipelines expand and technical challenges mount, sponsors are increasingly relying on outsourcing partners well before commercialization.
Aug. 19, 2026
The integration of chemical engineering into process development has transformed how companies scale, control, and optimize manufacturing for a new generation of therapies.
June 25, 2026
The draft guidance allows developers to leverage chemistry, manufacturing and controls data, as well as nonclinical and clinical information from ⁠other relevant products.
June 3, 2026
As regulatory support grows for botanical therapies, developers face the complex task of standardizing nature for pharmaceutical production.
May 8, 2026

Information Technology

Sponsored
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...
April 15, 2026
Software platforms can seamlessly integrate with emerging technologies to unlock efficiencies, strengthen sustainability and enable proactive prevention of disruptions.
Sept. 10, 2025
To prioritize data integrity in the lab, companies must implement good data practices throughout the R&D process
June 24, 2024
Built-in ability to meet data integrity standards should be a central focus when selecting control systems and manufacturing execution systems for pharma manufacturing
May 2, 2024

Compliance

The CRL relates to Good Manufacturing Practice observations at third-party manufacturer NerPharMa, and a request for additional commercial-scale consecutive batch data.
Aug. 20, 2026
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.
Aug. 10, 2026
As one of seven companies picked for the pilot, the integrated development and manufacturing organization says regulatory engagement cuts commercialization risk.
July 9, 2026
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.
June 30, 2026

Quality & Risk

The drugmakers pledged to invest $19.6 billion collectively in U.S. manufacturing and provide discounts on select medicines in exchange for tariff exemptions.
Sept. 1, 2026
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.
Aug. 18, 2026
The agency wants to increase the fee starting in fiscal 2028 for all foreign API, finished dosage form, and contract manufacturing organization facilities.
Aug. 13, 2026
The CDMO’s new platform reflects a broader shift toward using artificial intelligence to help teams manage increasingly complex manufacturing data.
Aug. 12, 2026