OSD Continuous Manufacturing – Platform to Technology: Current and Future Good Practices from an Owners & Engineers Perspective |
The industry started to apply the principles of Continuous Manufacturing (CM) of Oral Solid Dosage (OSD) forms more extensively in the mid-2000s. OSD-CM has now advanced to approved commercial manufacture of new and legacy drug products around the globe. Industry and regulatory bodies have embraced CM technologies, which have been proven to lead to decreased costs and time in product development as well as robust assurance of final product quality. As more companies integrate CM into their development and commercial operations the demand for more flexible, modular and robust systems is needed. Additionally more harmonization and guidance to owners and regulators for achieving this had been demanded.
In 2017 an international team, comprised of end user pharmaceutical companies, engineering firms, equipment vendors, and academics, set out to establish equipment requirements, identify opportunities for harmonization and flexible integration, and suggest enhancements to current equipment/processes. Their work culminated in the publication of the ISPE CM of OSD Forms - Good Practice Guide (GPG), released in 2022. This Guide provides a resource for owner companies and engineers as they design and integrate CM systems into their operations, highlighting best practices and opportunities for enhancement.
This session will provide an Engineers and Owners perspective of how to best use this new guidance today and in the future. Dave DiProspero will discuss, from an engineer’s perspective, how the GPG was developed and how its use can help design firms understand and meet their clients rigorous design requirements. Bart Nitert will discuss, from an owner’s perspective, the key important elements from the guide to pay close attention to and the challenges Janssen have faced when merging equipment from different vendors into a single continuous manufacturing and how these challenges were resolved.
Senior Fellow | Director of Pharmaceutical Process Technology,