The API is, one might say, the most important element in a pharmaceutical product. Poor-quality APIs that do not meet potency ...

Calquence (acalabrutinib) plus bendamustine and rituximab reduced risk for disease progression or death by 27% compared with ...

Scientific, economic, and practical factors should be considered when choosing between the frozen state and lyophilization.

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The PharmTech Group interviewed Edwin Stone, CEO of Cellular Origins, about how geopolitical instability in Europe, and ...

The White House is instructing FDA to increase fees for and inspections of foreign drug manufacturing plants and reduce the ...

Amit Chivate, senior market manager, Greater Asia and China, Roquette, provides his perspective on FDA’s recommendations ...

Sustainability-by-design in bioprocess development, according to Adam Goldstein, senior director of R&D Collaborations at ...

As therapeutic modalities evolve, so do the challenges and methodologies associated with maintaining and verifying cleanroom ...

BioPharm International® sat down with Noah Kopcho, field application scientist at Gyros Protein Technologies, to talk about ...

While global harmonization exists, there are still differences between the US and European GMP requirements that ...

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