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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

Now touring: Cell and gene therapy

Germfree Labs’ city-by-city educational series addresses challenges and solutions in CGT manufacturing

Sterling Pharma Solutions: Paving a better way

How one CDMO's dedication to technology is making a global impact

Allogeneic approaches to CAR-T

How off-the-shelf T-cell platforms can make manufacturing CAR-T therapies more feasible and scalable

Leave no CMC stone unturned

Building a CMC strategy for biologics is a critical, multistep process

A right-first-time approach to development

Commonly overlooked issues may have a deep impact on cell and gene therapy commercialization timelines

News

Avantor expands SUT footprint as demand grows

Thermo Fisher announces major expansion plans

Biden to announce 'historic' partnership between Merck and J&J

Sanofi steps in to produce Pfizer vax

Recipharm inks deal to manufacture Moderna vax

Moderna begins at-risk vax production

Engineering Angles: A flexible future

Overcoming operational challenges in cell and gene therapy production

Engineering Angles: Fast-tracking access to treatments

How CDMOs are supporting a paradigm shift in pharma manufacturing

Consistent measurements from lab-to-process

Smooth scale-up requires using similar measurement technologies from the lab to full production

AZ343-Gartuna-Sodertalje-Sweden-aerial-view-copy

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

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

The COVID CDMO

Emergent BioSolutions' contract and development manufacturing business has put it at the epicenter of biodefense

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

Sanofi caves to French government’s concerns over coronavirus vax

After Sanofi’s CEO, Paul Hudson, publicly stated last month that Americans would be first in line for any approved coronavirus vaccine from the company, the fallout was swift....

White House names five companies with most promising vaccine candidates

With the goal of securing a supply of coronavirus vaccines for Americans, the Trump administration has identified the five companies it believes have the most promising candidates...

Novavax buys manufacturing plant to ramp up vaccine production

U.S.-based Novavax has struck a deal to purchase a manufacturing plant from the Serum Institute of India (SII) as it aims to produce 1 billion doses of its coronavirus vaccine...