The company said the investment is in response not only to customer demand and a belief in the value of US-based innovation, but also because of the trend toward US onshoring brought about by new ...

The PharmTech Group interviewed Edwin Stone, CEO of Cellular Origins, about how technological advances will impact the biopharma industry in the future.

The API is, one might say, the most important element in a pharmaceutical product. Poor-quality APIs that do not meet potency levels and/or those that harbor impurities can create safety risks for the ...

As therapeutic modalities evolve, so do the challenges and methodologies associated with maintaining and verifying cleanroom sterility. Cleanroom standard operating procedures (SOPs) are the ...

Calquence (acalabrutinib) plus bendamustine and rituximab reduced risk for disease progression or death by 27% compared with the current standard of care, according to a phase III trial.

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

The White House is instructing FDA to increase fees for and inspections of foreign drug manufacturing plants and reduce the time required to approve such sites that will be newly constructed in the US ...

The PharmTech Group interviewed Edwin Stone, CEO of Cellular Origins, about how geopolitical instability in Europe, and beyond, has impacted the bio/pharmaceutical supply chain.

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

BioPharm International® sat down with Noah Kopcho, field application scientist at Gyros Protein Technologies, to talk about the challenges in the production of AAV vectors.

Sustainability-by-design in bioprocess development, according to Adam Goldstein, senior director of R&D Collaborations at Thermo Fisher Scientific, involves integrating sustainable practices and ...

While global harmonization exists, there are still differences between the US and European GMP requirements that manufacturers should know, says Siegfried Schmitt, PhD, vice president, Technical at ...