Simplification of Continuous Tableting for Accelerated Product Development and Lifecycle Flexibility

This episode of Drug Digest explores new and emerging technologies, such as mass photometry, machine learning, and AI, and their role in the analytical space for biologic modalities.

Register Free: https://www.pharmtech.com/pt_w/lifecycle-flexibility

Series Overview

This comprehensive webinar series, focused on continuous manufacturing of oral solid dosage forms, also known as continuous tableting (CT), aims to highlight key opportunities, successes and challenges with continuous tableting. Content of the webinars will cover the role of CM along a wide breadth of the CMC journey, starting with lean and model-based development and concluding with commercial implementation of continuous tableting processes. Each webinar in the series will be presented as a joint talk with participants from innovators, like Merck and Vertex Pharmaceuticals, and Hovione highlighting experiences from each organization and the many advantages of a partnership-based approach. Featured experts will be available to answer audience questions during a live Q&A that will follow each talk.

The webinar series will conclude with a final presentation, shared as a joint talk between GEA and Hovione announcing exciting joint innovations in the CT equipment space along with the latest advances in technology simplification.

Third Session Overiview:

One of the main practical challenges for the uptake of continuous manufacturing in the pharmaceutical industry has been managing the complexity of introducing new technology into the daily working culture and practices. Considering oral solid dosages, otherwise defined as continuous tableting (CT), there has been an evolution of the equipment offered by vendors from product-specific needs towards a more generalized platform approach mostly driven by the incorporation of learnings from successful industrialization programs and regulatory approvals. However, pharmaceutical manufacturing continues today to be functionalized for batch-based manufacturing paradigm around the areas of equipment, development workflows, quality system, and regulatory/CMC mindset. The introduction of continuous tableting has been disruptive to a degree, resulting in many aspects of CT being perceived as complex relative to the batch paradigm and this leads to a natural perception of risk and hesitance for widespread adoption.

This third webinar in the series, presented as a joint talk between Hovione and GEA, will highlight some of the key areas Hovione and GEA have identified for CT where complexity is seen as a bottleneck for increased adoption and exchanging it for flexibility. Namely, the key features of the latest version for the Consigma continuous direct compression Flex will be discussed in the context of accelerated development and routine manufacture. In addition, the collaborative efforts from the Hovione-GEA partnership that have yielded opportunities to simultaneously simplify process development in the lab and on the manufacturing shop floor will be shared. This inherent simplification is driven by keeping the complexity “under the hood” and rooted in the latest trends around digitalization and aspects of artificial intelligence.

Key Learnings for the Webinar Series:

• Learn about a lean approach to process development that leverages the use of process models to inform development of continuous tableting processes. Learn how limited but carefully considered experiments inform powerful models that facilitate development of robust processes.
• Learn about important considerations in commercial implementation of continuous tableting. This includes lessons learnt over the course of the lifecycle of such programs starting from installation of the equipment, through qualification, tech transfer and finally during commercial manufacturing.
• Hear about experiences with scaling commercial operation including cleaning operations by means of carefully curated case studies.
• Learn about the latest development from the Hovione-GEA partnership on continuous tableting, specifically, on a flexible approach to direct compression along with the latest advances in technology simplification

Who Should Attend:

• Individuals and organizations who wish to hear peer experience about the implementation of continuous tableting technology – from R&D to commercial manufacturing.
• Current and aspiring practitioners of the technology who are curious about process development approaches, and how the use of process models can inform lean development.
• Operational excellence specialists who would like to hear about the application of simulation modeling approaches to optimize resource allocation and cycle times.

Speakers:

Anthony Tantuccio
Fellow Scientist, Technology Intensification
Hovione

Anthony Tantuccio joined Hovione L.L.C. as a Fellow of Continuous Tableting (CT) in the beginning of 2022. He has worked in the drug product development and commercialization area for 15 years with a technical, tactical, and strategic focus on implementing continuous manufacturing for oral solid dosage forms. He has previously worked for Merck (USA) and Bristol Myers Squibb on products supporting early phase clinical manufacturing through process qualification and launch in both batch and continuous paradigms. At Hovione, he is an influencer at the interfaces of the key functional areas which are responsible for implementing and industrializing CT. Finally, he has a passion for data management and analysis, process control and integration, and process analytic technology, all of which are critical considerations when implementing continuous manufacturing.

James Holman
Senior Director, Technology Management
GEA Group

Dr Jim Holman is the Senior Director for Technology Management for the Pharmaceutical Solid Dosage business within GEA’s Food and Healthcare Division. Jim is responsible for all new product innovations and developments across the continuous, batch, compression and material handling solid dosage business as well as leading industrial and academic collaborations to advanced process understanding in these areas.

Along with his PhD in continuous Twin Screw Granulation and master’s degree in chemical engineering, Jim has over 17 years’ experience focusing upon the development and application of novel and new technologies supporting the manufacture of solid dose products, as well as sustainability projects within the pharmaceutical field. Jim has been involved in multiple industrial collaborations with pharmaceutical companies during his time at GEA and has authored / co-authored over 12 academic publications on the topic of continuous manufacturing.

Register Free: https://www.pharmtech.com/pt_w/lifecycle-flexibility