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.

Thermo Fisher Scientific continuous manufacturing services include:

  • Capability based at Greenville, NC, for oral solid dose products
  • 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 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, part of 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
  • Simplifying scale-up
  • 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. Under the guidance of Eric Jayjock, PhD, Director of Continuous Manufacturing at Thermo Fisher Scientific and an industry-recognized expert in these techniques, the team will help you 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, 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

Speak with our continuous manufacturing experts to see if this solution is a fit for your project.