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Industry News

The new Shaoxing site adds 250 cubic meters of reactor capacity, with room for future expansion to more than 400 cubic meters.
Oct. 23, 2026
The Nanjing site supported a customer program from investigational new drug development through biologics license application submission.
Oct. 23, 2026
The facility will produce antibody-drug conjugates and other advanced medicines, with capacity for both active pharmaceutical ingredients and finished products.
Oct. 22, 2026
The new platform adds amorphous solid dispersion manufacturing to the Couvet site’s existing oral dosage and packaging operations, according to the company.
Oct. 22, 2026

Learning Resources

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Explore how Consistone™ Yeast Extract UF may support CHO growth and productivity, with study data on batch and fed-batch performance, titer, and consistency.
Oct. 15, 2026
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Explore study data on peptone strategies for CHO growth, antibody titer, and consistency, with insights for batch and fed-batch processes and stalled productivity.
Oct. 15, 2026
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See how a supplement-based approach may support CHO productivity while keeping development options open, with study data to help guide your evaluation.
Oct. 15, 2026
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See how yeast-derived supplements compared in a CHO study, with data on antibody titer, cell growth, and compositional consistency.
Oct. 15, 2026

Podcast

Editors' (re)View

Lilly broke ground this week on a $6.5 billion active pharmaceutical ingredient facility that will make Foundayo, while Novo is expanding its oral Wegovy capacity.
Sept. 25, 2026
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

Production

Not likely, argues Kymanox Executive Advisor Roger Lias, despite recent advances in continuous manufacturing for antibodies and other recombinant biologics.
Sept. 30, 2026
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

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

Overseas markets take on increased attractiveness for India following President Trump’s threatened tariffs on generic drugs in 2028, finds data and analytics firm.
Oct. 13, 2026
As injectable and oral GLP-1s evolve, pharma companies face tough choices about capacity, delivery platforms, outsourcing, and supply resilience, says CPHI Milan panel.
Oct. 7, 2026
The share of newer FDA-approved innovator and biosimilar products whose production mix included a Chinese facility is rising, says data and analytics firm.
Sept. 28, 2026
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