Continuous Manufacturing: Offering Flexibility and Greater Process Control

Historically, drug products have been made in a batch process where API and excipient materials are added in discrete steps in predetermined amounts and processed in discrete phases usually on separated equipment trains. The ‘batch’ is measured by weight or volume. With continuous manufacturing, materials are moved non-stop through an integrated equipment train, eliminating hold times between processing steps and the ‘batch’ essentially becomes a question of time.

Continuous Manufacturing Services

Thermo Fisher Scientific continuous manufacturing services include:

Advantages of Continuous Manufacturing

Advantages of a continuous manufacturing suite include:

Today, Patheon, by Thermo Fisher Scientific, is revolutionizing how medicines are made through continuous manufacturing. This allows materials to be processed in an uninterrupted stream. Our modular design, nonstop, fully integrated process is not restricted to batch size and offers a range of advantages, including:

Step-wise batch processing is reliable but wastes valuable time and resources. Batch processing also runs the risk of introducing contamination and mistakes when product is held up between steps. Continuous manufacturing can overcome these issues. The Thermo Fisher approach to continuous manufacturing brings quality control to the next level. Starting materials are fed into the process train, the materials flow through one or more operations, and the final product is collected at the line end. Technicians continuously monitor the process. The team can use information from one operation to adjust other operations before or after it in the same stream. This tighter process control means we can better manage inter-batch variability for clinical trial supply without wasting time and resources on producing batches of unusable material.

Applications of a Continuous Manufacturing Drug Line

Continuous manufacturing is useful for diverse applications, including:

Benefits of Continuous Manufacturing

Key advantages of this state-of-the-art continuous manufacturing suite include:

As the FDA and other global regulators increasingly prefer the use of continuous manufacturing as a more reliable and safer drug manufacturing technique, you can benefit by outsourcing your project to the industry leader in continuous manufacturing.

Learn more about continuous manufacturing in these videos:

Continuous Manufacturing in Patheon’s Greenville, NC Site
Patheon’s Eric Jayjock discusses Continuous Manufacturing
Podcast: Advantages of Continuous Manufacturing w Patheon’s Eric Jayjock

Download our whitepaper, “Solving the OOS Problem with Continuous Manufacturing.”