Stuart R. Gallant, MD, PhD With around 25,000 drugs in clinical development globally at any given moment, deals to purchase and to sell developmental molecules…
Tag: Pharmaceutical Manufacturing
Product Recalls
Stuart R. Gallant, MD, PhD There are 20,000 to 25,000 prescription and OTC medications licensed in the United States, and every year there are about…
Pharmaceutical Process Scale-Up
Stuart R. Gallant, MD, PhD A friend of mine who has been employed in pharmaceutical manufacturing for decades has a saying regarding process scale up. …
AI in Pharma R&D and Manufacturing
Stuart R. Gallant, MD, PhD Artificial intelligence is being widely adopted in fields like law, accounting, banking, customer service, marketing, and human resources. These early…
Approval Rate and Development Cost by Drug Category
Stuart R. Gallant, MD, PhD Takeda just announced that it would exit cell-based treatment research [1]. Last year, Takeda had ended development of its non-Hodgkin…
Contract Manufacturing in the Age Tariffs
Stuart R. Gallant, MD, PhD Almost three years ago, PharmaTopo carried a post describing the process of selecting and working with a contract manufacturer [1]. …
Challenges in Sterile Filling
Stuart R. Gallant, MD, PhD Parenteral products require sterility whether they are liquid vials, lyophilized vials, or prefilled syringes. This week’s post on Pharmatopo addresses…
Pharmaceutical Shelf-Life Determination
Stuart R. Gallant, MD, PhD Pharmaceutical shelf-life determination affects patient safety by assuring that the strength, quality, purity, and potency of an investigational or commercial…
3 Dimensions of Early Pharmaceutical Formulation
Stuart R. Gallant, MD, PhD In the pre-clinical phase of pharmaceutical development, the project team wants to demonstrate drug efficacy in animal models, as well…
Selecting an Analytical Laboratory
Stuart R. Gallant, MD, PhD Analytical testing is required to verify the identity, strength, quality, purity, and potency of investigational and commercial products. The precise…
Small Molecule and Antibody Release Specifications—Lessons Learned
Stuart R. Gallant, MD, PhD Drug substance and drug product release specifications have numerous uses throughout the product lifecycle. They guide process development and provide…
Preparation of an Investigational New Drug (IND) Application
Stuart R. Gallant, MD, PhD A pharmaceutical company begins development of a new drug by screening dozens or even thousands of molecules to find the…
The 4 Axes of Drug Development Readiness
Stuart R. Gallant, MD, PhD In the earliest stages of drug research, scientists conduct bench experiments at a university or in a corporate pharmaceutical research…
Tactics for Managing the Unforeseen
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…
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…
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…
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…