Last week, Freund-Vector attended the Commercializing Continuous Processing Summit (CCP) in Boston, Massachusetts. The focus of this summit was continuous processing within the pharmaceutical industry. Industry leaders from the biopharma, synthetic and solid dosage provided insights into their continuous manufacturing journey.
The first challenge was understanding the definition of continuous. Someone might use continuous processing while others may say continuous manufacturing or continuous production. For simplicity purposes, there are slight differences but overall, they are the same thing. “Continuous production is a flow production method used to manufacture, produce, or process materials without interruption. Continuous production is called a continuous process or a continuous flow process because the materials, either dry bulk or fluids that are being processed are continuously in motion, undergoing chemical reactions or subject to mechanical or heat treatment.“ (Wikipedia)
The second challenge is building a business case for continuous manufacturing. Below are some questions you should consider:
- How do you convince your organization to switch?
- Discuss your upfront investment costs against the long-term benefits.
- How can you bridge the gap between science and business strategy?
- Process Analytics Technology (PAT) and quality monitoring: When and why should you conduct business analysis on technology?
- Discuss time to market: Will continuous manufacturing accelerate or delay?
- Define your risks and establish mitigation plan.
During discussions regarding continuous manufacturing, you need to define specific goals and objectives that you are attempting to achieve. What and how are you going to measure?
The final challenge is regulatory compliance. Experts stressed that it is never too early to begin communications with regulatory agencies. Regulatory agencies tend to focus on these three areas:
- Control strategy
- Process Variation
- PAT methods and models
Schedule face to face meetings and pre-operational visits with regulatory agencies prior to new drug application (NDA). Quality by Design (QbD) should be used in conjunction with your continuous manufacturing process development. Leveraging QbD assists with increasing regulatory agencies’ confidence in process and control strategy.
This summit did a great job of showcasing the success of continuous manufacturing in the pharmaceutical industry. Yes, there are many challenges yet to be discovered but part of the journey is discovering the problem and developing solutions to overcome those problems.
Freund-Vector is interested in learning about your solid dosage continuous manufacturing journey. Why are you considering adopting continuous manufacturing for your tablets and capsules? What are your challenges? When are you expecting to start this journey? We have developed the Granuformer® , which is an innovative system that can perform granulation and drying continuously. The granules are continuously delivered into a newly developed spiral dryer and dried by heated air, and then collected by the cyclone. Feel free to provide your comments to Kurt.Scheetz@Freund-Vector.