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Industry News

The Raichur campus expansion will add 10 kiloliters of synthesis capacity, with the first commercial production line scheduled to open next month.
Nov. 4, 2026
The program includes vaccine scale-up and manufacturing by SK bioscience with the company’s CDMO subsidiary, IDT Biologika, responsible for fill-finish operations.
Nov. 4, 2026
The expanded agreement adds six commercial biologics programs at the CDMO’s Denmark facility to five already assigned to its site in Japan.
Nov. 3, 2026
The site has finished its first Good Manufacturing Practice batches of drug substance and drug product, advancing its overseas production operations.
Nov. 3, 2026

Learning Resources

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No matter where you are in the pharmaceutical lifecycle, learn how to reduce environmental monitoring blind spots, maintain GxP compliance, and ensure a smoother audit process...
Oct. 30, 2026
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How can biomanufacturers reduce contamination risk from cell culture to final fill? Explore five SaniSure single-use technologies for closed processing, low-shear mixing, sterile...
Oct. 28, 2026
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This presentation addresses key considerations for developing and validating ADC-specific analytical methods, including DAR distribution, free payload, conjugational heterogeneity...
Nov. 18, 2026
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AI is already on the life sciences shop floor and on regulators' radar. Pairing FDA and MasterControl perspectives, this brief details how to build a defensible, compliant AI ...
Oct. 26, 2026

Podcast

Editors' (re)View

The rival CDMOs are increasingly going head-to-head in key business areas, including high-volume mammalian production and antibody-drug conjugates.
Oct. 23, 2026
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

Production

A BioMADE-funded project demonstrated programmed cell-wall lysis at pilot scale, reducing the mechanical energy required for separation by more than 50% in one yeast strain.
Oct. 22, 2026
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

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

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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