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Industry News

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FDA White Oak Campus, headquarters of the United States Food and Drug Administration, a federal agency of the Department of Health and Human Services (HHS)
The program is designed to accelerate development of therapies addressing major U.S. health priorities, including domestic manufacturing of essential medicines.
Oct. 17, 2025
Ardena
Ardena site
The collaboration aims to produce Peptinovo’s drug-delivery platform ahead of planned human clinical studies.
Oct. 17, 2025
AstraZeneca
AstraZeneca manufacturing worker
The Coppell site expansion will add two new manufacturing lines and double potassium binder Lokelma production for U.S. and global patients.
Oct. 16, 2025
European Union
Pharma worker administers vaccine
The Kigali site in Rwanda will produce mRNA vaccines to help build a resilient and sustainable vaccine ecosystem in the region.
Oct. 16, 2025

Learning Resources

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Sponsored
Join industry specialists as they share their insights, experiences, and strategies to enhance efficiency, reduce costs, and improve product quality in the production of non-traditional...
Nov. 11, 2025
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Innovative approaches to help address high productive methods of mAb polishing
Sept. 24, 2025
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Explore an efficient tool for simultaneous aggregate and HCP removal
Sept. 24, 2025
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Facing challenges when purifying non-traditional mAbs?
Sept. 24, 2025

Podcast

Editors' (re)View

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While the plant was recently hit with the FDA’s most severe post-inspection classification, it is a facility that has been plagued with problems for several years.
Oct. 17, 2025
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Industry stakeholders who attended the annual Cell & Gene Meeting on the Mesa this week in Phoenix emphasized the positive, despite formidable challenges.
Oct. 10, 2025
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Since the start of his second term, President Trump has doubled, tripled, and quadrupled down on his threat to impose tariffs on pharmaceuticals. Is it just bluster?
Oct. 3, 2025
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Companies are competing to secure construction workers including electricians in the Tar Heel State, where biotechnology ranks as the fastest growing sector.
Sept. 26, 2025

Production

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Panelists at the 2025 Cell & Gene Meeting on the Mesa laid out the challenges and opportunities facing the industry as it looks to produce these therapies at scale.
Oct. 7, 2025
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In the fast-changing pharmaceutical sector, packaging is more critical than ever to patient safety and product provenance.
Oct. 1, 2025
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Despite industry setbacks with adeno associated virus-based gene therapy programs, the issue is “largely overblown” for Repligen, contend Leerink Partners analysts.
Sept. 11, 2025
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The CDMO acquired the 128,000-square-foot cell and gene therapy facility in Hopewell last year, which is now ProBio’s North American hub.
Aug. 25, 2025

Development

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The agency is reviewing clinical trials that involve sending U.S. patients’ living cells to China and other “hostile countries” for genetic engineering and return infusion.
Sept. 22, 2025
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Sponsored
With manufacturers under increasing pressure to reduce costs, enhance compliance, and accelerate production timelines for high quality drugs, they are increasing their investments...
Aug. 25, 2025
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The future of non-clinical research may depend on integrating VCGs for a more humane and efficient approach.
Dec. 5, 2024
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Sponsored
Improve bioreactor performance, accelerate process development from benchtop to production, assess respiratory efficiency with continuous CO2 monitoring, eliminate potential interferenc...
Nov. 22, 2024

Information Technology

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Software platforms can seamlessly integrate with emerging technologies to unlock efficiencies, strengthen sustainability and enable proactive prevention of disruptions.
Sept. 10, 2025
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Sponsored
Pharmaceutical manufacturing operates in a high-stakes environment where regulatory compliance, product integrity, and operational uptime are non-negotiable. As the industry becomes...
March 5, 2025
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Discover the latest contract manufacturing key trends for the life science industry, including compliance, digital transformation and more. Don't let your organization fall behind...
Feb. 24, 2025
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As the life sciences sector evolves with personalized medicine, biologics, and digitalization, manufacturers must innovate, invest in advanced tech, and adopt agile manufacturing...
Jan. 30, 2025

Compliance

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Sponsored
This episode of Off Script: A Pharma Manufacturing Podcast features a conversation with Jana Falkenberg, senior legal counsel and corporate compliance officer at Vetter Pharma...
Oct. 17, 2025
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Designed for the review of abbreviated new drug applications, the program is meant to strengthen the domestic pharmaceutical supply chain in the United States.
Oct. 6, 2025
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The deadline for imposing a 100% tariff on branded pharmaceuticals passed, without going into effect, as the Trump administration looks to strike deals to lower drug prices.
Oct. 2, 2025
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The drugmaker secured a three-year reprieve for its products from tariffs under a Section 232 investigation, provided it further invests in U.S. manufacturing.
Oct. 1, 2025

Quality & Risk

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The industry’s inability to make products efficiently and at scale is due to the complexity of the supply chain, panelists said at the Cell & Gene Meeting on the Mesa.
Oct. 8, 2025
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Sponsored
Read more about how WarmMark QR addresses today’s common cold chain monitoring challenges through an innovative combination of visual and digital tracking.
April 25, 2025
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Adhering to a tried-and-true set of best practices during the PPQ stage can prevent a drug approval from stalling out on the final lap.
Feb. 18, 2025
Michael Annino | Shutterstock-AI
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How pharma can use CAPA as a tool to support continuous process improvement
June 20, 2024