Commercial Reality and Lifecycle Management of ASDs

Follow the complete journey of amorphous solid dispersions (ASDs), starting from the early formulation stage to process development and scale-up, and finally to commercial reality and lifecycle management of ASDs.

Register Free: https://www.pharmtech.com/pt_w/early-formulation

Third Session Overview:

Welcome to the third and last webinar of our 3-part webinar series "Amorphous Solid Dispersions by Spray Drying: From Early Formulation to Commercial Lifecycle Management."

Over the course of this series, Hovione experts will guide you through the complete journey of amorphous solid dispersions (ASDs), starting from the early formulation stage to process development and scale-up, and finally to commercial reality and lifecycle management of ASDs.

After presenting Hovione’s formulation screening and scale-up methodologies for amorphous solid dispersions (ASDs) by spray drying, the webinar series will conclude by discussing the link between development, process validation and lifecycle management.

Inês Salsinha and Tiago Porfirio will explain how to perform a critical and extensive evaluation of potential failure modes, how to carry out risk assessment and how to define criticality, to enable a successful Process Performance Qualification (PPQ).

Commercialization of ASDs requires statistical tools and methodologies to enable the continued process verification (CPV) application and ensure that the process remains under control. In this session, participants will gain insights into the importance of continuous improvement supported by continuous data analysis. The speakers will also outline the importance of commercial experience when using spray drying to produce ASDs. Case studies, namely regarding post approval changes, will be presented, and discussed.


Your Key Learning Objectives:

• Learn how to apply Quality Risk Management tools to get a successful Process Validation while ensuring a robust commercial stage
• Learn how statistical tools support the commercial lifecycle enhancing process control and product quality
• Discover how Continued Process Verification (CPV) and Product Quality Review (PQR) are key for a continuous improvement strategy

Who Should Attend:

This webinar is suitable for anyone working in formulation and process development of amorphous solid dispersions, procurement, and outsourcing teams or project managers, who are interested in understanding the end-to-end process for validation and commercialization of an ASD by Spray Drying.

Hovione experts featured in this webinar will be available to answer your questions during a live Q&A.

Don't miss the other sessions in the series!

Session 1: Evaluating the Best Formulations for Amorphous Solid Dispersions by Spray Drying
This event is now available on demand.

Session 2: ASDs by Spray Drying: Process Development & Scale-Up
This event is now available on demand.

Series Overview

The Hovione team presents a new comprehensive three-part webinar series on "Amorphous Solid Dispersions by Spray Drying: from early formulation to commercial lifecycle management" starting February 28, 2023.

Over the course of this series, Hovione experts will guide participants through the complete journey of amorphous solid dispersions (ASDs), starting from the early formulation stage to process development and scale-up, and finally to commercial reality and lifecycle management of ASDs.

As an experienced manufacturer of ASDs by spray drying for the pharmaceutical industry, Hovione will be able to share its extensive knowledge and experience. Furthermore, the featured experts will be available to answer your questions during a live Q&A.


Key Learning for the Webinar Series

• Gain knowledge on designing a successful formulation for Amorphous Solid Dispersions produced by Spray Drying
• Discover how to develop a robust process at lab scale and assure a successful scale-up
• Learn how to use a model-based methodology to establish the design space and a commercial process
• Understand what to consider during the Lifecycle Management of a commercial Amorphous Solid Dispersion by Spray Drying

Speakers:

Inês Salsinha, M.Sc.
Quality Assurance Specialist Site QA
Hovione

Inês Salsinha is a Quality Assurance specialist at Hovione’s Site QA area. She joined Hovione in 2017. During four years she led ASD projects as a QA specialist and after that she joined the Drug Product Formulation group, as the QA assigned for Continuous Manufacturing. Currently, she is a subject matter expert on topics such as data analysis and statistical tools. With a great interest in digitalization, she has been enabling the implementation of Automatic Reports, such as the Product Quality Review.

Inês holds a Master’s degree in Pharmaceutical Sciences from Faculdade de Farmácia, Universidade de Lisboa.

Tiago Porfirio, Ph.D.
R&D Manager, Particle Engineering Corporate Technical Services
Hovione

Tiago Porfirio is an R&D Manager in the Particle Engineering team, which is integrated within the Corporate Technical Services. Tiago joined Hovione in 2014. He has focused his research on first principle models and data science to establish model-based methodologies to expedite spray drying process development. Recently, his work has been dedicated to the post-approval stage particularly to how data, models, and prior knowledge can be applied for continuous improvement, while also focusing on risk review during lifecycle management.

Tiago holds a Ph.D. in Engineering Design and Advanced Manufacturing from the University of Lisbon and is the author of two patents.

Register Free: https://www.pharmtech.com/pt_w/early-formulation