Glossary Definition: Clinical Manufacturing

In drug production, clinical manufacturing is the process of manufacturing drugs to support clinical studies on human subjects. These studies answer questions about the safety and efficacy of drugs and procedures, to determine if they should be commercialized and manufactured at scale.

Clinical studies need to be supported by drug product throughout the phases. Clinical manufacturing makes cGMP materials that are administered to patients enrolled in clinical studies. During clinical studies, researchers monitor patients to determine the safety and efficacy of the drug. The drug then progresses through four distinct phases based on the results gathered from these patients.

As drugs move through these phases, a larger patient population is needed to support the movement to commercialization. For this reason, the manufacturer needs to be able to produce a higher quantity of the drug to satisfy the needs of the study.

Clinical studies involve testing a drug, procedure, or treatment on human subjects. It happens in four phases, with each phase containing unique goals, participants, and timelines.

What happens in Phase 1 clinical trials?

The first phase takes less than a year to complete, and involves up to 100 people. The people may be completely healthy or may suffer from a particular illness the drug aims to treat.

This phase serves two main purposes: 

1. To understand how the treatment works in humans 
2. To determine the correct dosage

Around 70% of drugs proceed from phase 1 to phase 2.

What happens in Phase 2 clinical trials?

The length of phase two varies. In some cases it lasts for only a few months, in others it takes years to complete. This phase involves up to hundreds of participants, all of whom suffer from the disease or condition. The goal of this phase is simply to determine the safety of the treatment.

Success rates during this phase drop substantially, with only 33% of drugs moving into phase 3.

What happens in Phase 3 clinical trials?

The third phase can take up to three years and involves between 300 to 3,000 people with the disease or condition. The purpose is to determine if it can help prevent, diagnose, or treat a disease. It also analyzes side effects and measures safety.

Approximately 60% of phase 3 drugs make it to phase 4.

What happens in Phase 4 clinical trials?

In the final phase, researchers spend years studying thousands of people with the disease and analyzing how the treatment or therapy works for them. Based on their findings, the treatment or therapy will either move forward to FDA review, approval, and commercialization or it will not. For approved drugs, this final clinical phase is often a bridge to commercial production, supporting the tech transfer that’s needed to manufacture at scale.

The clinical and preclinical stages of drug development have a number of differences:

• During preclinical development, researchers collect and analyze information. They test different therapeutics on animals and lab-grown human cells to determine if it makes sense to move drugs to human trials. Ultimately, they are responsible for establishing a process that will produce a drug safely and reliably.
• Clinical studies take years to complete and involve the four phases outlined above. Each phase is designed to test and analyze the safety and efficacy of drugs on human subjects.

Clinical studies are important because they weed out ineffective and unsafe drugs from entering the market. During clinical studies, researchers carefully analyze how drugs interact with human participants.

In some cases, they determine therapies should be commercialized based on their ability to work as intended, and treat or cure diseases. However, the vast majority of time (in 90% of cases), drugs fail during clinical trials.