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Industry News

Lonza
Stein, Switzerland Lonza facility
The CDMO has brought a new aseptic vial filling line online at its Stein site, adding containment technology for highly potent biologics.
Oct. 9, 2025
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Checklist, investigation and female biologist with clinic protocol development for pharmaceutical study
The collaboration grants Catalent global rights to incorporate Lisata’s certepetide peptide into antibody-drug conjugates developed on its platform.
Oct. 9, 2025
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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 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 a cell and gene therapy site in Durham, adding commercial-scale viral vector production and fill-finish capacity to its U.S. network.
Oct. 8, 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
editreview
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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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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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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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
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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

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