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Industry News

Hovione
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The New Jersey investment more than doubles Hovione’s U.S. spray drying capacity to support solubility enhancement and bioavailability in drug development.
Oct. 27, 2025
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The investment reportedly enhances solid-phase peptide synthesis and purification capacity to strengthen domestic production of active pharmaceutical ingredients.
Oct. 27, 2025
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Galderma logo on cell phone screen with digital stock finance bars in background
The Swiss dermatology company plans to ramp up production of key brands including Nemluvio, Alastin and Cetaphil through U.S.-based contract manufacturing partners.
Oct. 24, 2025
Serán BioScience
Aerial view of Serán manufacturing facility
The new 100,000-square-foot campus in Bend will enhance Serán’s U.S. production capacity for small molecule therapeutics.
Oct. 24, 2025

Learning Resources

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Read Part 2 of this SmartNote series with Dr. Tim Sandle to learn about putting environmental monitoring theory into practice.
Oct. 24, 2025
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What do we want to achieve with our environmental monitoring program? Read Part 1 of this SmartNote series with Dr. Tim Sandle to learn more.
Oct. 24, 2025
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Learn about the role of environmental monitoring in a robust contamination control strategy to maintain product integrity and safeguard patient safety.
Oct. 24, 2025
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Explore proven alternatives to fetal bovine serum (FBS). Discover how donor bovine serum and other options can reduce cost and supply risks while maintaining performance in bioproductio...
Oct. 21, 2025

Podcast

Editors' (re)View

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The two bellwethers of the CDMO industry reported strong financial results for the third quarter of 2025 amid uncertainty in geopolitics and funding.
Oct. 24, 2025
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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

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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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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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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CEO Pascal Soriot announced the deal with President Trump on Friday, noting that it includes a three-year exemption from U.S. tariffs for AstraZeneca’s products.
Oct. 10, 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

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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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