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Industry News

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Female scientist working with samples, using micro pipette to analyze in a lab
The Germany-based CDMO has named its Cuxhaven facility a Center of Excellence for Analytical Services, expanding GMP lab capacity to support advanced therapy and biologics programs...
Oct. 8, 2025
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Digital DNA structures sit in foreground and in background a researcher test vials
The UK-based CDMO acquired an FDA-approved cell and gene therapy site in Durham, North Carolina, adding commercial-scale viral vector production and fill-finish capacity to its...
Oct. 8, 2025
Lonza
Close up of gloved researcher's hands working on equipment in a Lonza biologics development lab
The CDMO introduced new cytokine and media systems designed to improve scalability, consistency and efficiency in viral vector and cell therapy production.
Oct. 7, 2025
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Adeno-associated virus
The Boston-based biotech’s system reportedly streamlines large-scale viral vector production and reduces costs and variability in gene therapy manufacturing.
Oct. 7, 2025

Learning Resources

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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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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
editreview
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
editreview
The Danish drugmaker has been conspicuously absent in 2025 from the flurry of high-profile Big Pharma commitments to invest billions of dollars in the United States.
Sept. 19, 2025
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Sun’s factory is under Import Alert until it becomes compliant with FDA and cGMP standards, while Hikal was hit with a warning letter due to repeated metal contamination.
Sept. 12, 2025

Production

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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
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The CDMO is building identical large-scale production facilities in the U.S. and Denmark, designed to modularly and seamlessly integrate manufacturing regardless of location.
June 9, 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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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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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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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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At the agency’s public meeting on the proposed PreCheck framework, companies said reductions in inspection-related delays could significantly de-risk and reduce timelines.
Oct. 1, 2025
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In a post on Truth Social, President Trump warned that companies who are not “building” their pharmaceutical manufacturing plants in the U.S. will be hit with tariffs.
Sept. 26, 2025
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Standing up GMP facilities in the United States takes approximately 32 months given permitting hurdles, say CDMOs who spoke with Leerink Partners analysts.
Sept. 23, 2025
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Pharmaceutical manufacturing hinges on the production of purified water that meets strict pharmacopeia regulations. To ensure consistent water quality, real-time monitoring is...
April 29, 2025

Quality & Risk

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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
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Aging populations are straining pharma production — here’s what the industry should do
May 30, 2024