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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.
Flexible equipment train with interchangeable modules for continuous dry mixing, wet granulation and dry granulation, with a ‘Swiss Army knife’ capacity to allow switch in/switch out depending on the client’s process requirements
New product development or ‘batch to continuous’ switches
Advantages of Continuous Manufacturing
Advantages of a continuous manufacturing suite include:
Less API is required for process development
Increased control over manufacturing parameters
Significantly smaller manufacturing footprint with higher utilization
Scale up is essentially eliminated
Not restricted to a predetermined batch size
FDA advocates for continuous manufacturing, as this provides increased process control, higher yields and less batch rejection
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:
Maximum flexibility to meet unique client product and capacity needs
Real-time monitoring and adjustment to maximize process control
Greater control over process validation to lower costs of product development and minimize batch rejection
Smaller facility footprint compared to conventional batch processing equipment
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:
Accelerating formulation and fast-track drug development
Reducing cost and risk when working with expensive starting materials
Improving process parameter testing for QbD studies
Enabling quick response to surges or declines in manufacturing demand
Making improvements to existing projects
Benefits of Continuous Manufacturing
Key advantages of this state-of-the-art continuous manufacturing suite include:
Flexibility: The expert engineers that designed this 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 allow you to cost-effectively make adjustments to commercial lines.
Expert guidance: Quality control and process design with continuous manufacturing requires a specific skillset. Thermo Fisher Scientific is a pioneer and innovator in continuous manufacturing. Our team of industry experts will help you build processes and programs that are not only robust, but also have flexible to adjust 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, 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.”