1. What is the reason behind the increased interest in continuous processing procedures? What are the main benefits?
As rules and regulations become more stringent and competition increases, continuous processing becomes necessary in order to ensure things are done right the first time. The greatest benefit of continuous processing is getting instant results, leading to better control over our processes before manufacturing is completed. Additionally, it increases process understanding and gives results for better decision making. Ultimately, this keeps a company competitive as it reduces time and cost.
2. Are all procedural steps designed and well established already? How far are we from the ideal construction?
We have PAT and QbD, which are relatively new to the pharmaceutical industry. I would say we are starting, but not yet at the ideal construction, if we are speaking of the industry as a whole. I believe it will take some time for the ideal construction to be reached.
3. How should this approach be implemented into the company practice? What are your experiences?
Implementation is difficult because many changes need to be made to documentation, equipment, state-of-the-art technology, etc. It’s best to change things gradually. Currently, we are facing many of these changes. We are not only ensuring continuous processing but also increasing knowledge. Due to continuous processing, we are able to decrease the time required for our processes, which can be used for more beneficial tasks, such as analyzing data, instead of constantly solving problems.
4. Is it relevant only for upstream professionals?
No, because continuous processing provides lean processes with an increase in results and knowledge; therefore, this procedure can flow downstream as we go about its implementation.
5. What are your research steps in the case of development of other fermentation techniques?
This is accomplished through seminars and other functions within the company, such as the technology group.