Developing an oral solid dosage (OSD) product is not easy; timelines are long, financial risks are considerable and challenges are many. Consequently, significant incentive exists to find efficiencies and streamline the product development process wherever possible. However, one aspect of the pharma development process remains unchanged. Regulatory agencies are unwavering in their demand for evidence that your manufacturing process is stable and the design space well defined; the result of a robust development process based on designing quality into the manufacturing process itself. Of course, meeting this significant challenge requires expertise and resources that companies, both large and small, often find in short supply. There are tools and partners available, however, that can help ease the pain of the development process.
In one of my recent articles, I talked about the Automated Process Development (APD) system from Syntegon. The APD system is a sophisticated tool that can help reduce tablet-compression and capsule-filling development timelines . When placed on one of our capsule filling machines, the APD system can automatically perform as many as fifty discrete capsule filling runs in as little as two hours, reducing the time required to perform a complex DOE from days, or even weeks, to just hours. Until now, the benefits of APD were available primarily at our OSD Customer Center in Waiblingen, Germany. However, that is about to change.
Syntegon is pleased to announce that our capsule-filling APD system will soon be available in the United States. Parsolex, located in West Lafayette, IN, aims to take delivery of a GKF 702 capsule filling machine with APD and make this technology available for use for client engagements by the end of 2021. Established in 2004, Parsolex is a world-class contract services company delivering analytical, development, manufacturing, and strategic advisory solutions to clients who are involved with non-sterile pharmaceutical products for clinical trials as well as commercialization. As full service CDMO, Parsolex offers a full array of oral solid dosage manufacturing capabilities, including high and low shear granulation, fluid-bed processing, tablet compression and coating, as well as encapsulation.
In 2019, Parsolex and Syntegon entered into a strategic alliance to showcase Parsolex’s capabilities on Syntegon equipment, including high shear granulation and tablet compression. Now, with the addition of Syntegon’s GKF 702 with APD, Parsolex will have the capability to significantly reduce the time it takes to optimize your capsule filling process. The powerful APD tool will allow Parsolex to fully characterize your capsule filling process by clearly identifying the interaction of critical process variables, helping you to identify the processing ranges that result in the best capsule filling process for your product.
Whether yours is a young “virtual” pharma company with limited manufacturing capacity, or an established organization struggling to find the resources and space within an existing facility, you can turn to Parsolex for expertise in formulation development and manufacturing. Now, with the addition of Syntegon’s APD system, you can be sure that Parsolex can solve your capsule filling problems as well.