Glossary Definition: Commercial Manufacturing

What is commercial manufacturing?

As its name suggests, commercial manufacturing is a stage of drug production whereby approved therapies are commercialized — meaning they’re manufactured at scale, marketed to consumers and healthcare organizations, and sold. This process involves adhering to Good Manufacturing Practices (GMP) and breaking down manufacturing into a series of repeatable steps.

The ultimate goal of commercial manufacturing is to take the established processes and figure out how to optimize them for mass production without compromising quality or safety.

What happens during commercial manufacturing?

Commercial manufacturing kicks off with a full FDA review. After the FDA approves a drug, manufacturing can begin. This involves turning raw materials into finished products, and includes specialized teams, equipment, materials, facilities, and various stages. During this process, the drug substance, aka the pure material of the drug, is turned into the drug product, the final finished form of the drug including its added ingredients and packaging.

Initially, a pharma company will set its commercial team up with the necessary data to begin manufacturing, such as the clinical trial reports and golden batch record. The next step is to create the first batch, which will be tested for quality, purity, and efficacy.

Drugs go through rigorous testing throughout the production process to ensure they are safe, cGMP compliant, and effective prior to commercialization.

To successfully manufacture drugs at scale, many pharma companies rely on technology powered by Artificial Intelligence (AI), including manufacturing execution systems (MES) and laboratory execution systems (LES). Advanced, cloud-based technologies like MES and LES solutions streamline drug production, allowing manufacturers to maintain quality control and compliance while working faster and more efficiently.

Commercial vs clinical: What’s the difference?

Unlike clinical manufacturing, which involves testing drugs on human subjects for safety and efficacy, commercial manufacturing is all about producing and commercializing new drugs at scale.

During this stage, drugs are manufactured, marketed, sold to pharmacies, hospitals, and doctors, and made available to patients.

Why is commercial manufacturing important?

Commercial manufacturing is important because it is the final crucial step after therapies are approved by regulatory bodies for mass production. It enables patients to receive drugs capable of preventing, treating, or curing various diseases and conditions.

In doing so, it helps to improve the quality of life for people around the world, by delivering them drugs that will help them live a longer, better, healthier existence.