Stuart R. Gallant, MD, PhD The Convention on Pharmaceutical Ingredients (CPhI) was just held in Frankfurt. As the self-described “leading networking event for pharmaceutical industry,”…
Tag: Manufacturing
Lipid Nanoparticles for Covid-19 Vaccines
Stuart R. Gallant, MD, PhD Hopefully, you have received your Covid-19 vaccine. If you did, there’s a pretty good chance it was delivered in lipid…
Pharmaceutical Design Focus: Factor VIII (1 of 2)
Stuart R. Gallant, MD, PhD Today’s post is a big story involving genetic engineering, pharmaceuticals, intellectual property, and economics. You will recall from the first…
Logistics: So, You Want To Move Your Drug?
Stuart R. Gallant, MD, PhD Okay, here’s the premise of today’s post: you have contracted with a company outside the US (maybe in Germany, China,…
Pharmaceutical Design Focus: Insulin
Stuart R. Gallant, MD, PhD Insulin is a subject on a lot of people’s minds—C&E News just came out with a cover story on insulin…
Knowledge Management and Knowledge Events (2 of 2)
Stuart R. Gallant, MD, PhD The first part of this two-post series addressed knowledge management and knowledge mapping. In this second part, the use of…
Raw Materials Testing, Starting Materials, and Contact Materials (2 of 2)
Stuart R. Gallant, MD, PhD In the first post of this series, raw materials risk analysis was discussed. In the second post of this series,…
Risk Assessment of Raw Materials and Contact Materials (1 of 2)
Stuart R. Gallant, MD, PhD One of the first steps in a pharmaceutical development project is selection of chemicals. For the development team, it may…
Drug Development Plan
Stuart R. Gallant, MD, PhD How A Drug Development Plan Originates Keller and Schnell suggest that there are five challenges to a pharmaceutical startup: 1)…
Parenterals and Covid-19
Stuart R. Gallant, MD, PhD The Biden administration has announced that it plans to invest billions of dollars in Covid-19 vaccine manufacturing capacity [1]. What’s…