Parsolex in Partnership with Syntegon Hosted a Technical Forum on “Solving Scale-Up and Technology Challenges in Batch and Continuous Pharmaceutical Production”
INDUSTRY UPDATE | Press release
December 22, 2020
West Lafayette, IN – Parsolex in partnership with Syntegon held a virtual Technical Forum on Tuesday, December 1, 2020, discussing the topic of “Solving Scale-Up and Technology Challenges in Batch and Continuous Pharmaceutical Production.”
“I’m proud that Parsolex created a channel for pharmaceutical manufacturing thought leaders to come together to discuss the current challenges in batch and continuous pharmaceutical production,” said Alfonso Chang, CEO of Parsolex. “This event is one example of how Parsolex is able to share key insights to the pharmaceutical industry.” A highlight of the program was the keynote address entitled “Progress in Industry 4.0 Implementation in Continuous Tablet Manufacture,” delivered by Dr. Rex Reklaitis, the Edward W. Comings Distinguished Professor of Chemical Engineering at Purdue University and Deputy Director, NSF Engineering Research Center on Structured Organic Particulate Systems.
Insights from the keynote and the panelists during a round table panel discussion on “How to Decide Between Continuous vs Batch?” include:
- Continuous manufacturing (“CM”) is gaining more interest from industry sponsors, CDMOs, and regulatory bodies for its benefits to the manufacture of high quality, safe and effective pharmaceutical products. Many lessons are being learned and applied from other industries where CM is already used.
- CM presents an opportunity to monitor quality using leading rather than lagging critical process and product attributes, offering improved process control, decreased risks for error, and increased operational efficiencies due to the elimination of sublots required in conventional batch-based manufacturing (“BM”). These factors help decrease the likelihood of batch loss, which is a contributing factor to drug shortages.
- However, CM requires higher upfront capital investments due to the increased complexity of the equipment and instrumentation required to execute a process on an uninterrupted basis; therefore, developing the criteria and the business case to justify CM for a given drug product is essential.
- A successful CM process implementation requires the sponsor to:
- Develop a robust control strategy early in the product and process design lifecycle, incorporating Quality by Design (“QbD”) and particle engineering principles, as appropriate
- Select appropriate excipients that will achieve the desired product performance as well as facilitate a robust process during longer continuous operations
- Leverage a combination of automation, process analytical tools, and design of experiment (“DoE”) to gain an understanding of the critical performance parameters and insights
- Understand design parameters upfront to optimize capital investments in required equipment and instrumentation, acknowledging that most new chemical entities (“NCE”) will enter clinical development using clinical trial materials (“CTM”) manufactured using BM strategies, transitioning to CM
- Have access to real-time measurements and ability to act on those measurements, possibly through the deployment of process analytical technology (“PAT”) that may need to be customized
In addition to the keynote presentation by Dr. Reklaitis, the following presentations were delivered during this Technical Forum by Syntegon:
- “Design of Experiments with Capsule Filling Process Automation: New Approach to Quality by Design”
- “Fast Tracking Compression Scale -Up from R&D to Production”
Parsolex would like to acknowledge and thank all the Technical Forum panelists and speakers, including:
- Thomas Brinz, PhD, Director, Pharma Services Waiblingen, Syntegon
- David Ewbank, Director Manufacturing Solutions, Parsolex
- Ammar Khawam, PhD, Manager, Development Solutions, Parsolex
- Tom Myers, Business Development Manager, Syntegon
- Stacy Pearce, Managing Scientist, Manufacturing Solutions, Parsolex
- Rex Reklaitis, PhD, the Edward W. Comings Distinguished Professor of Chemical Engineering at Purdue University and Deputy Director, NSF Engineering Research Center on Structured Organic Particulate Systems
- Tony Stuckwisch, Director Quality Assurance, Parsolex
- Nathan Wade, PhD, Senior Managing Chemist, Analytical Solutions, Parsolex
This Technical Forum was moderated by David Engers, PhD, Director, Client Services, Parsolex.
Please follow Parsolex on social media outlets (i.e., LinkedIn, Instagram, and YouTube) and visit www.parsolexinc.com to stay informed on pharmaceutical development and manufacturing insights and on future events.
About Parsolex – Parsolex is derived from the words “Partner, Solutions, Excellence” – the foundation of everything we do. Since 2004, our experienced team has been committed to innovation in product and process design, development, current Good Manufacturing Practices (“CGMP”) manufacturing and testing of solid oral dosage forms. We strive to achieve the success of all our clients to improve patient lives around the world. Parsolex operates a CGMP facility equipped with state-of-the-art manufacturing and analytical technologies located in West Lafayette, Indiana, USA, that is registered with the U.S. Food and Drug Administration. Parsolex’s technical capabilities include formulation and process development, including first-in-human strategies; clinical trial material manufacturing, scale-up, and technology transfer for a broad range of oral solid dosage forms, including but not limited to tablets, film-coated tablets, and hard gelatin capsules filled with powder, granule, and coated-beads; analytical method development and validation services; ICH stability storage; CGMP warehousing; and CGMP commercial manufacturing. Furthermore, Parsolex offers commercialization and strategic advisory services. Learn more at www.parsolexinc.com.
About Syntegon (formerly Bosch Packaging Technologies) – Based in Waiblingen near Stuttgart, Germany, and employing 6,300 associates, Syntegon is one of the leading suppliers of process and packaging technologies. At over 30 locations in more than 15 countries worldwide, a highly qualified workforce develops and produces complete solutions for the pharmaceuticals, food, and confectionery industries. These solutions are complemented by a comprehensive after-sales service portfolio and a global service and sales network to provide customers with local points of contact. Learn more at www.syntegon.com.
About Parsolex – Syntegon Relationship – Announced in November 2019, Parsolex and Syntegon have entered into a close cooperation. As part of this strategic alliance, Parsolex will benefit from the latest packaging technologies for pharmaceutical manufacturing, while Syntegon will gain access to a manufacturing site in the U.S. to showcase its technological capabilities. The two organizations will conduct joint research projects that demonstrate Parsolex’s capabilities on Syntegon’s machines. Furthermore, both partners will host events on market trends, technological innovations, and manufacturing in the pharmaceutical industry.