In Part I of this two-part series, we explored sourcing and supplier management of Regulatory Starting Materials (RSMs), and how effective designation and justification of RSMs begins with supplier market…
Supply chain management is an essential chapter in the pharmaceutical manufacturing handbook. Managing regulatory starting materials (RSMs) seeks to maximize commercialization and sustainability while meeting and/or exceeding regulatory requirements. Drugmakers…
In 1905, George Santayana published his famous aphorism: “Those who cannot remember the past are condemned to repeat it.” More than 100 years later, this is could be an unofficial guiding principle…
We’ve arrived at a time in which real-time remote GMP inspections of drug manufacturing facilities are an actual thing – and not just an “it would be nice to have…
A recent article at DCAT Value Chain Insights (Generics: What is the Next Industry Move?) shone a light on recent movements in the generics space by the MNCs, including Novartis…
Green initiatives may be slowly gaining some traction across the pharmaceutical industry, but there is still a long way to go. These are some astonishing insights from sciencehistory.org. “On a waste-to-product…
Drug development is exciting. There’s no getting around it: being a part of an industry which aims to improve human health is a great motivator for waking up and heading…
There’s a growing consensus in the pharmaceutical industry that drug makers should embrace green chemistry. The last decade of pharma manufacturing has seen green chemistry practices shift from aspirational stewardship…
AstraZeneca’s $39-billion acquisition of Alexion Pharmaceuticals joined by Merck’s acquisition of Acceleron for $11.5 billion and other deals, have made the Rare Disease space a destination for Big Pharma this…
Scientific breakthroughs in the pharmaceutical industry can happen overnight, but it still takes time to perfect a discovery’s applications. Deuterium-labeled active pharmaceutical ingredients (APIs) are one specific advancement that has…
