Continuous Manufacturing - What You Need to Think about Before Implementing
The future is bright, the solution for all your problems has been found! One piece of equipment does it all – it will bring your Solid Dose Drug Product development, tech transfer, and manufacturing costs down, all while reducing your quality risks.
Well… eventually it will, and you will have to put in significant time and effort to get there - dollars will help as well. What should you start thinking about now before implementing a continuous manufacturing process?
First you will have to choose if you will start off immediately with new products or learn by converting a legacy batch product into a continuous process without the hot breath of a launch down your neck. Feasibility assessments can be done together with vendors, universities, and CMO’s – which can help you to select the first product to bring to the market.
Your development and deployment strategy will help to guide you if you make a few important choices early on:
- Will you focus your equipment on one product, or should it be capable for a range of products in the portfolio?
- Should it be as lean as possible, with fast change over time, good yield, simple design – or as flexible as possible: having lots of PAT, different technologies, to be ready for a broad portfolio and several control strategies?
- What would be your control strategy: rely on RTD models, PAT, would you go for full, partial or no Real Time Release?
Your business case will help you to focus during the equipment engineering phase as well:
- Tech Transfer benefits require lines as similar as possible between development and commercial production
- Development benefits need API sparing techniques
- Commercial benefits need equipment to be lean, functional with low supervision, easy to clean, fast change over, and good yields
- Speed to market requires a short and reliable project implementation timeline.
It would be great if all these aspects were combined in one equipment, but unfortunately, this is not the case (yet).
Pharmaceutical companies, vendors, health authorities, and academia are still working hard on collecting and generating the knowledge which is necessary to have a good understanding of how material characteristics impact the product quality attributes, and what the influencing factors in the dynamic environment of a continuous process are. Luckily, the result of that work is often shared at conferences and in publications, which reduces the time needed for all to get to a critical mass of knowledge needed to achieve the benefits this fantastic technology promises. One can even call it unprecedented in the pharmaceutical industry – the extent to which collaborations and shared experiences are shaping the implementation of continuous processes, especially regarding control strategies and equipment design. Pre-competitive collaboration clearly has advantages for all!
Still, there are some clusters of working groups and knowledge that could be more effectively integrated: regional (US, Europe, and Asia) or Technological (API design, PAT, Batch/CM regulatory groups…). Bringing these groups together would be beneficial for progress and alignment – and would bring us one step closer to that future brightness.
Continuous manufacturing continues to be one of the most talked-about pharma trends. Be prepared to transform your operations! Get the first-hand knowledge mentioned above from renowned global industry, regulatory, and academic experts who have influenced and implemented continuous manufacturing strategies and successfully launched products using the new technology. Register today for the ISPE's 2018 Continuous Manufacturing Workshop 6 – 7 June in Arlington, VA.