Continuous OSD manufacturing
Why the shift from batch to continuous for pharmaceutical oral solid dosage form tablet manufacture is now upon us.
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.
With the recent FDA approval of Janssen Pharmaceutical's transfer from batch process to continuous process manufacturing for the HIV drug Prezista® in April 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 that is 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.
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Annual Salary Survey
Before the calendar turned, 2016 already had the makings of a pivotal year for manufacturing, and for the world.
There were the big events for the year, including the United States as Partner Country at Hannover Messe in April and the 2016 International Manufacturing Technology Show in Chicago in September. There's also the matter of the U.S. presidential elections in November, which promise to shape policy in manufacturing for years to come.
But the year started with global economic turmoil, as a slowdown in Chinese manufacturing triggered a worldwide stock hiccup that sent values plummeting. The continued plunge in world oil prices has resulted in a slowdown in exploration and, by extension, the manufacture of exploration equipment.
Read more: 2015 Salary Survey