Simplifying the Pharma Supply Chain and Speeding Medicines to Market
Thermo Fisher Scientific is the first CMO to build and manufacture client product on a continuous manufacturing line. The suite, located at the Patheon CDMO site in Greenville, North Carolina, is custom built to utilize the best equipment available. The cutting-edge process allows materials to flow through several small-unit operations without stopping. The result? Lower costs, reduced interbatch variability, and tighter process control.
What’s wrong with traditional batch processing?
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.
What’s right with continuous manufacturing?
The Thermo Fisher approach to continuous manufacturing brings quality control to the next level. Materials are fed into the process at one end—flowing through unit operations in a continuous stream—with the final drug product being produced at the other 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.
Continuous manufacturing is useful for diverse applications, including:
- Accelerated formulation and fast-track drug development
- Reduce cost and risk when working with expensive starting materials
- Simplifying scale-up
- Better process parameter testing for QbD studies
- Quick response to surges or declines in manufacturing demand
- Improvements to existing projects
Flexibility. The expert engineers that designed this state-of-the-art suite built the line to be flexible with the ability to combine equipment units (e.g., blenders, feeders, mills, presses and more) in numerous configurations to optimize process parameters, quality and yield without the need for change control. Wet and dry granulation are both possible. We can quickly and reliably respond to changes in demand or process variability (potentially avoiding shortfall).
Simpler process development. Customers can easily prototype and test processes, creating time and cost-efficiencies for R&D projects.
Streamlined scale-up. Because batch size and quality are not determined by equipment scale, continuous manufacturing simplifies scale-up to commercial quantities.
Cost savings. Because continuous manufacturing enables efficient adjustment of processes in real-time, entire batches are not made (and discarded) for the purpose of confirming process parameters. Reducing API usage in this manner can slash development time and expenditures as well as to cost-effectively make adjustments to commercial lines.
Expert guidance. Quality control and process design with continuous manufacturing requires a specific skillset. Thermo Fisher is a pioneer and innovator in continuous manufacturing. Under the guidance of Eric Jayjock, PhD, Director of Continuous Manufacturing at Patheon, a part of Thermo Fisher Scientific, and an industry-recognized expert in these techniques, the team will help drug makers build processes and programs that are robust, yet have the flexibility to be adjusted when needed.
As the FDA and other global regulators increasingly prefer the use of continuous manufacturing as a more reliable and safer drug manufacturing technique, outsource your project with the industry leader in continuous manufacturing.