Novartis announces a new API facility in Morrisville, NC, as part of its $23bn US manufacturing expansion, boosting biopharma ...

Biotechnology giant Thermo Fisher Scientific announced the opening of a US Bioprocess Design Center (BDC) on its campus in ...

GeoVax CEO David Dodd highlights the need for U.S. manufacturing to reduce reliance on foreign biotech and strengthen ...

Process intensification has reduced the cost of mAb manufacturing, but tweaks across bioproduction will be needed to reduce ...

Andelyn Biosciences and ENCell collaborate to streamline gene therapy development, leveraging US–APAC networks for faster ...

To ensure product safety and efficacy, protein therapeutics must meet defined quality characteristics immediately after manufacture as well at the end of their designated shelf lives. Many physical ...

Millie Nelson is the Partnering and Investment editor at BioXconomy. She studied English Literature at university and started her journalism career as a reporter and then editor of BioProcess Insider.

The biopharmaceutical industry is at the forefront of technological advancements, with “biopharma 4.0” revolutionizing the way biomanufacturing is conducted (1). The concept combines automation, ...

Challenges One difficulty with cleaning validation, as experience has shown, is in establishing clear and consistent processes. Cleaning validation often is considered as an afterthought rather than ...

Synchronizing CMC Activities with Clinical Development: for Robust and Compliant Biomanufacturing from Bench to BLA CMC success requires coordinated evolution of manufacturing and analytical methods ...

Ionizing-technology–based industries are growing rapidly around the world. The expansion is driven mostly by the technology’s myriad applications, including polymer crosslinking, medical device ...

AntiD (trinbelimab, BSV Bioscience) prefilled syringe with safety device. Prefilled syringes (PFSs) are an optimal method of delivering biologics because they provide for easy administration, decrease ...