Insights from Commercial Implementation of Continuous Tableting: Successes and Challenges of a Partnership-Oriented Approach

Hear Key Learnings From Commercial Implementation of Continuous Tableting Processes

Register Free: 
https://www.pharmtech.com/pt_w/commercial-implementation

Event Overview:

Upcoming Sessions:

Session 3: July 10, 2024: “Simplification of Continuous Tableting for Accelerated Product Development and Lifecycle Flexibility”First Session Overiview:

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.

Second Session Overiview:

This webinar, jointly presented by speakers from Hovione and Vertex Pharmaceuticals, focuses on key learnings from commercial implementation of continuous tableting processes. Hovione and Vertex have been long-time collaborators in continuous tableting and the talk will draw on the experience of this partnership. The authors’ experience of scaling the team and the operation informed by rigorous time-study data coupled with on-field experience will be shared. A case study on how such time studies can be used to develop scheduling models to inform resource allocation and for a change of line (COL) exercise will also be shared. The use of bespoke tools and aids to improve overall manufacturing cycle times, such as investigation templates, will be discussed. Lastly, both organizations will present perspectives on key learnings from the implementation and commercialization of the technology.

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:

Sarang Oka
Fellow Scientist, Technology Intensification
Hovione

Dr. Sarang Oka is a Scientific Fellow at Hovione where he is tasked with intensifying the implementation of continuous tableting within the organization. In his prior roles at Hovione, Dr. Oka was responsible was various functions at Hovione’s continuous drug product manufacturing installation (CT501) in East Windsor, New Jersey, including PAT, technical services and manufacturing operations where he successfully led the validation and tech transfer of a commercial program from one of Hovione’s partners to CT501. Dr. Oka received his PhD in Chemical Engineering from Rutgers University. Dr. Oka holds a BS in chemical engineering from Mumbai University.

Filipe Ataide
Scientist, Oral Formulation Sciences
Hovione

Filipe Ataide is a senior scientist in the Technology Intensification group at Hovione, specializing in improving both Spray Drying and Continuous Tableting standards. Prior to his current role, Filipe held several positions in R&D position related to Knowledge Management group and process modeling, simulation and scale-up of chemical processes, developing data integration/visualization tools and mathematical models to monitor and forecast key metrics for the organization. He was also the team lead of the Continuous Manufacturing group in Drug Substance. Filipe Ataíde holds a PhD since 2016 in Chemical Engineering with strong background in modeling, simulation and optimization of chemical processes.

Alexandre Bonnassieux
Manager, Technical Operations Drug Product
Vertex Pharmaceuticals

Alexandre Bonnassieux is a Manager in the Technical Operations Drug Product group at Vertex Pharmaceuticals based in Boston, MA. Upon joining Vertex, Alexandre supported the development and technical transfer of new drug products from early clinical to commercial stages as an R&D scientist in the Continuous Manufacturing (CM) group. In his current role as a lead process engineer, he supports all aspects of the commercial production of oral solid dose products which utilize CM equipment trains across the Vertex manufacturing network. Prior to joining Vertex in 2020, Alexandre worked at Pfizer, Inc. as an R&D scientist supporting development and commercialization of drug products, as well as contributing to multiple CM equipment installations at global sites. Alexandre received his Bachelor of Science in Mechanical Engineering from Boston University.

Register Free:
https://www.pharmtech.com/pt_w/commercial-implementation