Scale-Up

Pharma companies can’t commercialize their products without scaling up manufacturing. Here, we offer insights on this complicated process and explore the issues surrounding how companies take laboratory-scale batches used in clinical trials to pilot-scale and then finally, to commercial-scale production.

Articles

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Now touring: Cell and gene therapy

Germfree Labs’ city-by-city educational series addresses challenges and solutions in CGT manufacturing
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Sterling Pharma Solutions: Paving a better way

How one CDMO's dedication to technology is making a global impact
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Allogeneic approaches to CAR-T

How off-the-shelf T-cell platforms can make manufacturing CAR-T therapies more feasible and scalable
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Leave no CMC stone unturned

Building a CMC strategy for biologics is a critical, multistep process
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PM2110-HERO-575x327-Development
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A right-first-time approach to development

Commonly overlooked issues may have a deep impact on cell and gene therapy commercialization timelines
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Engineering Angles: A flexible future

Overcoming operational challenges in cell and gene therapy production
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Engineering Angles: Fast-tracking access to treatments

How CDMOs are supporting a paradigm shift in pharma manufacturing
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Consistent measurements from lab-to-process

Smooth scale-up requires using similar measurement technologies from the lab to full production
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Global Dose: Focus on Sweden

Known for its R&D innovation, Sweden’s pharma industry sets out to prove its manufacturing prowess to the world
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A one-stop-shop for advanced therapies

The Center for Breakthrough Medicines is poised to come online as the world's largest single-site CDMO for cell and gene therapies
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The COVID CDMO

Emergent BioSolutions' contract and development manufacturing business has put it at the epicenter of biodefense
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Building a comprehensive approach to process safety

Assessment methods along the product development journey have to be extensive and rigorous to achieve successful scale-up
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Coronavirus vaccines: The billion dose dash

Can pharma meet its lofty goals for coronavirus vaccine production?
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COVID-19: A world seeking normalcy waits to see if pharma can pull off the extraordinary

There was still a hint of optimism in the air when President Donald Trump called a special meeting at the White House with his newly formed coronavirus task force on March 2. ...
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In pharma, cancer is king

Inside the industry's quest for its next crowning achievement in oncology