Lean Process Development for Continuous Tableting: Foundations of a Hybrid Approach

Join us for this webinar focused on the development of continuous tableting processes.

Register Free: https://www.pharmtech.com/pt_w/continuous-tableting

Event Overview:

Upcoming Sessions:
Session 2: June 20th: “Insights from Commercial Implementation of Continuous Tableting: Successes and Challenges of a Partnership-Oriented Approach”
Session 3: July 10th: “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.

First Session Overview:

The first webinar of the series focuses on the development of continuous tableting processes. The webinar, presented as a collaborative talk, shares institutional experience on lean development methodologies, specifically, how a hybrid approach results in development of robust processes while minimizing the use of the active pharmaceutical ingredient (API) and time on the integrated process. The webinar will discuss in detail how carefully curated experiments inform process models, which in turn inform process performance. Success and challenges associated with this approach will be shared via means of case studies focused on loss-in-weight feeders. This webinar will be co-presented by speakers from Hovione and Merck Sharpe and Dohme.

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:

João Henriques
R&D Director, Oral Drug Product Development
Hovione

João Henriques, MSc, is the director of oral drug product development at Hovione R&D, specializing in formulation, particle engineering, and process development of pharmaceutical drug products for oral delivery. With a degree in Biological Engineering from the U. Lisbon, Portugal, João started his professional career in biopharma before joining Hovione in 2008. There, he has worked within Operational Excellence and Process Analytical Technologies groups before starting as a scientist in the Drug Product Development group at R&D, where he gained extensive experience in spray drying and drug product formulations and processes.


James Tarabokija
Scientist, Oral Formulation Sciences
Merck Sharpe & Dohme

James Tarabokija is a scientist in Oral Formulation Sciences at Merck Sharpe & Dohme, specializing in continuous manufacturing formulation and process development. He is responsible for material sparing lab tests and pilot scale assessments to determine the feasibility of continuous manufacturing for new pipeline assets. James holds a bachelor’s degree in chemical engineering and a master’s degree in pharmaceutical engineering from the New Jersey Institute of Technology.

Register Free: https://www.pharmtech.com/pt_w/continuous-tableting