Stuart R. Gallant, MD, PhD Sooner or later, something goes wrong in our work lives. In pharmaceutical manufacturing, errors or “deviations” are common events, and…
Pharmaceutical Manufacturing
So, You Want to Consult
Stuart R. Gallant, MD, PhD Consultation—offering your professional services to companies on a time-limited basis—can be a rewarding type of work. It is gratifying to…
Trends in Pharmaceutical Autoinjector Design and Use
Stuart R. Gallant, MD, PhD In today’s post, some important aspects of development and manufacture of combination products with pharmaceutical autoinjectors are considered. Pharmaceutical autoinjectors…
Subcutaneous Suspensions for Challenging Formulations
Stuart R. Gallant, MD, PhD In today’s post, we will look at subcutaneous suspensions as a way of meeting difficult drug delivery challenges. To decide…
Solving Drug Shortages
Stuart R. Gallant, MD, PhD Imagine that you have an infection, and you need a common antibiotic, but you cannot find a drugstore that is…
Oral Delivery of Protein Drugs
Stuart R. Gallant, MD, PhD Proteins and peptides are commonly delivered subcutaneously and by infusion; however, these approaches have disadvantages. Among the chief problems are:…
Immediate, Delayed, and Extended-Release Drug Products
Stuart R. Gallant, MD, PhD The focus of today’s post is oral drug release—immediate, delayed, and extended. Many technologies exist for controlling drug release—the focus…
Selecting and Working With a Contract Manufacturer
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,”…
Pharmaceutical Product Launch
Stuart R. Gallant, MD, PhD Above is a photo from the 1947 launch of the M.V. St. Essylt at J.L. Thompson and Sons was a…
Pharmaceutical Design Focus: Clot Busters (2 of 2)
Stuart R. Gallant, MD, PhD In the first part of this post, we looked at urokinase. In the second part, we will look at tissue…
Pharmaceutical Design Focus: Clot Busters (1 of 2)
Stuart R. Gallant, MD, PhD This November will be the 35th anniversary of the approval of tissue plasminogen activator (tPA, alteplase) a leading treatment for…
Pharmaceutical Supply Chain Risk Management
Stuart R. Gallant, MD, PhD As pharmaceutical supply chains have become global, the risk management of drug supply has become increasingly complex. Recently, I was…
The Design Process
Stuart R. Gallant, MD, PhD In Pharmaceutical manufacturing, frequently process development uses designed plays—just like in American football. In football, the play caller looks at…
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 (2 of 2)
Stuart R. Gallant, MD, PhD In the first part of this two-part post, we looked at the biochemistry of clotting factor Factor VIII and the…
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…
Technology Focus: Supercritical Fluid Chromatography
Stuart R. Gallant, MD, PhD This post is the first in an occasional PharmaTopoTM series called “Technology Focus.” Today, we look at supercritical fluid chromatography…
Financial Metrics of Pharmaceutical Companies (2 of 2)
Stuart R. Gallant, MD, PhD In the second part of this two-part post, the topic of valuation will be discussed, followed by how some of…
Financial Metrics of Pharmaceutical Companies (1 of 2)
Stuart R. Gallant, MD, PhD This two-part post looks at pharmaceutical companies and how they are financially structured to survive in a competitive market, to…
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…
Nonclinical and CMC (3 of 3)
Stuart R. Gallant, MD, PhD Non-clinical development has two chief goals: 1) to develop safety data enabling the entry of the medicine into human clinical…
Intellectual Property (2 of 3)
Stuart R. Gallant, MD, PhD Licensors and Licensees As discussed in Part 1 of this three-part series, drug development and licensing has taken on the…
Cost of Pre-Clinical Development (1 of 3)
Stuart R. Gallant, MD, PhD In the last three decades, how pharmaceutical drug development occurs has changed dramatically. Prior to this change, a significant share…
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…