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Industry News

The collaboration will support process optimization, scale-up, and cGMP manufacturing for Genprex’s AAV-based diabetes gene therapy candidate.
Sept. 2, 2026
The company has validated chemical fingerprinting and biological potency assays to assess batch-to-batch consistency of its botanical drug candidate.
Sept. 2, 2026
The new Fellbach facility includes cleanrooms, a powder laboratory, and production equipment for tablet and capsule development and testing.
Sept. 1, 2026
The Santiago facility received EXCiPACT certification for pharmaceutical excipient manufacturing covering commercial-scale QS-21 and other saponin fractions.
Sept. 1, 2026

Learning Resources

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This webinar will highlight green practices, waste reduction efforts, water conservation, evolving regulations, and emerging trends as the industry looks to mitigate its environmental...
Sept. 24, 2026
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The pharmaceutical packaging market is poised for robust growth, fueled by the demand for safe, convenient, and sustainable solutions. Smart and active packaging technologies ...
Aug. 25, 2026
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Learn how oxygen-enriched biological treatment helps pharmaceutical manufacturers unlock up to 50% additional wastewater treatment capacity, improve oxygen transfer efficiency...
Aug. 7, 2026
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Pharmaceutical construction projects face rising delays and costs. Learn how early supplier engagement, smarter coating strategies and expert field support can protect schedules...
July 27, 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

Manufacturers are expanding capacity while adopting automation, isolator technology, and new workforce strategies to meet increasing demands.
Aug. 6, 2026
Non-contact cleaning is often preferred to reduce the potential for cross contamination by removing loose fibers and dust.
July 30, 2026
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.
July 29, 2026
CEO Marc Casper says the company’s DynaDrive single-use bioreactor platform is becoming the “favored” technology for efficient, scalable bioproduction.
July 27, 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

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
Kansas-Missouri’s $34 million will translate biologic discoveries into U.S. production, while Virginia’s $16 million will develop and scale pharmaceutical manufacturing.
July 22, 2026