Tracy Beth Høeg said she was fired; Katherine Szarama departs as acting CBER director but remains at FDA, signaling rapid ...

Mihaela Simianu and Austin Caudle join the show to discuss how digital container twins can improve pharma manufacturing, validation, and risk reduction.

Understand how Piramal leads the CDMO market in delivering well-constructed and well-executed integrated services. Learn why programs need to consider both drug substance and drug product from the ...

Building resilient, adaptable operations capable of evolving alongside the rapid transformation of the biologics industry is key for downstream processing.

There is a significant reliance on manual workarounds. When a drug becomes unavailable, pharmacy teams may need to compound ...

Upstream titers of 3–5 g/L, and up to 10–13 g/L, are outpacing downstream capacity, creating chromatography, filtration, and UF/DF throughput bottlenecks that elevate cost and delay timelines. Complex ...

European biopharma companies are looking beyond GLP-1s. Obesity is a major public health threat and is associated with an increased risk of obesity-related complications and mortality. It has proved a ...

Benralizumab gained approval for adult and pediatric hypereosinophilic syndrome with a 65% flare-risk reduction, underscoring lifecycle strategies that impose distinct dosing, formulation, and ...

This week, the industry saw rapid technological integration on the factory floor, a strategic shift toward globalized development networks, and leadership upheaval at the FDA. The pharmaceutical ...

Sandra Coufal, Toragen, discusses her team's research targeting precancerous cervical cells, backed by a Gates Foundation grant and world-class advisors.

John Price, owner and MD of John Price PharmaSolutions LLC, is a life sciences regulatory and safety veteran and consultant. Formerly holding leading safety roles at Alexion, Johnson & Johnson, and ...

Through consideration of the ionic equilibria of acids and bases, one may readily calculate the formation constant of a salt species solely on the basis of knowledge of the pKA value of the acid and ...