Clinical Manufacturing: What It Is And How It Works

Manufacturing pharmaceuticals for the market is very different from manufacturing pharmaceuticals for a clinical trial. Naturally, there’s a difference in scale, but there are other unique challenges that must be met to maximize the likelihood of a successful clinical trial. In this article, we’ll discuss the basics of clinical manufacturing, including the current good manufacturing practice (cGMP) guidelines, bottlenecks, the difference between clinical manufacturing vs. commercial, and the benefits of specialty clinical trial manufacturing services.

First, let’s talk about clinical research, which is the third stage of the drug development process.

Clinical research is the first stage that looks at how a drug interacts with the human body, although clinical research can be performed on both animal and human subjects. Drugs that are being tested and researched in this stage of the process are not usually manufactured the same way or in the same facilities as drugs that are in commercial production.

This article reviews:

• What Is Clinical Manufacturing?
• How Clinical Manufacturing Works: cGMP Guidelines
• Clinical Manufacturing vs. Commercial: What’s the Difference?
• Benefits of Specialty Clinical Trial Manufacturing Services