“Although it is not easy for drug manufacturers to transition from batch to continuous manufacturing, there are significant rewards. FDA encourages others in the pharmaceutical industry to consider similar efforts.” Lawrence Yu, Ph.D. – FDA Deputy Director, Office of Pharmaceutical Quality, Center for Drug Evaluation and Research
For those of us working in the pharmaceutical OSD form manufacturing sector, we have seen the intense interest and strong emphasis recently being given to the continuous OSD manufacturing process as an alternative or addition to the traditional batch manufacturing process. This CRB blog will highlight a few of the main reasons why this is occurring.
With the recent FDA approval of Janssen Pharmaceutical’s transfer from batch process to continuous process manufacturing for the HIV drug Prezista® in April of 2016 and the July 2015 approval of Vertex’s cystic fibrosis drug Orkambi, also being manufactured via continuous processing, the stage appears to be set for additional continuous process approvals of many more tableted prescription products that have typically been manufactured via the traditional batch process.
The reasons for this paradigm shift are becoming clearer and more defined as more and more pharmaceutical companies begin to engage in product development and transfer using continuous OSD manufacturing process methods and technologies.
There are numerous process case and business case advantages associated with making use of the continuous process that are driving this effort. Five of the key generally agreed-to reasons are listed below:
Strong FDA Support for the Initiative
The FDA and other international regulatory bodies are strongly advocating the adoption of advanced manufacturing applications and technologies with an emphasis on continuous process, consistent with the FDA quality initiatives, as related to the following factors:
- Implements modern manufacturing approaches
- Potentially improves overall drug quality and consistency
- Enables Quality by Design (QbD) and full process understanding
Improved Product Quality/Safety
The primary drug product manufacturing objective is to ensure the highest levels of product quality, safety and consistency. With continuous process, improved quality and safety can be achieved. The process offers several advantages:
- Enables quality to be directly built into the process design
- Allows for real-time process monitoring and adjustment
- Results in stable and robust process operations
The pharma industry is under intense pressure to control and reduce drug costs and improve operational efficiencies. The use of continuous process offers cost reduction opportunities too:
- Requires a much smaller facility footprint and support space areas
- Lowers capital equipment cost and overall operating cost
- Uses significantly less API during product development
Bringing Product Development and Commercial Manufacturing Together
Taking new products from the lab and clinical phase to commercial manufacturing is one of the biggest challenges the industry faces from both a time and a cost standpoint. The application of continuous processing closes the gap between drug development and commercial manufacturing and actually ties the two together:
- Eliminates scale up and tech transfer; the same system/equipment that is used for development can be used for commercial manufacture
- Offers ease and control of design of experiments to access critical attributes
- Provides for accelerated product development ideal for breakthrough therapies and significant to the FDA
Numerous Operational Efficiency and Processing Enhancements
- Traditional batch processing has inherent inefficiencies and unit operation challenges that are easily overcome through continuous process. Some of these improvements are listed below:
- Improved system closure and better containment of the processing operation
- Significantly quicker time from “powder in” to “tablet out” (minutes compared to days or weeks)
- Flexibility to quickly meet product demand variations
- FDA supported real-time release testing through use of in-process data PAT and sophisticated process modeling
Continue at: https://www.pharmaceuticalonline.com/doc/why-the-shift-from-batch-to-continuous-for-pharmaceutical-oral-solid-manufacturing-is-now-upon-us-0001?vm_tId=2040405&user=ecdedf82-5ca8-4e3a-ae85-2fb49dc5c2f0&utm_source=et_6214180&utm_medium=email&utm_campaign=PHARM_12-16-2017-Top10&utm_term=ecdedf82-5ca8-4e3a-ae85-2fb49dc5c2f0&utm_content=Why+The+Shift+From+Batch+To+Continuous+For+Pharma+Oral+Solid+Manufacturing+Is+Upon+Us
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