Elizabeth Hickman (Chief Business Officer, AustinPx) explains the company's approach to improving bioavailability, ...

Brian Feth and Jonathan Grinstein go behind the headlines to discuss the impact of a Republican administration on Federal ...

Application of Validation Principles to the Training Quality System: Part 9, Quality Risk Management Hazard Identification ...

CDER Director Patrizia Cavazzoni and CBER Director Peter Marks provided an update on the rare disease innovation hub in a new FDA Voices blog post.

Pharmaceutical Technology® caught up with Brittany Hayes, PhD, Highly Potent & Oncology Platform Director at CordenPharma, ...

Traditional formulations commonly struggle to achieve content uniformity with morphologically challenging active pharmaceutical ingredients (APIs), requiring the use of complicated processes such as ...

FDA's approval will allow Kedrion to manufacture Ryplazim (plasminogen, human-tvmh), the only FDA-approved therapy for treating PLGD-1, at facility in Bolognana, Italy.

Stay compliant with Annex 1 for early phase sterile fill finish processes. Discover how to implement robust contamination control strategies, integrate isolator technology, and conduct integrity ...

Application of Validation Principles to the Training Quality System: Part 9, Quality Risk Management Hazard Identification ...

The Thousand Oaks, Calif., cell therapy manufacturing facility now houses new production suites, updated development labs, and more after expansion.

Elevate your viral screening with Eurofins BioPharma Product Testing’s qPCR- based assays. Our advanced testing goes beyond standard screenings to detect even dormant and hard-to-detect pathogens, ...

Lonza signed a long-term supply agreement to manufacture CASGEVY (exagamglogene autotemcel) for Vertex at its facility in Geleen, the Netherlands, and plans to expand manufacturing to Portsmouth, NH, ...