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Webinar: ASDs by Spray Drying: Process Development & Scale-Up

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Wednesday, March 22, 2023 - 16:00
Location: online
Webinar - ASDs Amorphous Solid Dispersions by Spray Drying | Hovione

This is the second session of a three-part webinar series on Amorphous Solid Dispersions by Spray Drying: From Early Formulation to Commercial Lifecycle Management.

 

Watch On-demand. 

Gated content. Registration is required.

 

Learn more about this webinar series here.

 

Featured Hovione experts in this webinar
Clara Sá Couto - Manager, R&D Oral Drug Product - Process Development Team | Hovione
José Luís Santos, Ph.D. Director, Technology Intensification | Hovione
Clara Sá Couto, Ph.D.

Manager, R&D Oral Drug Product,

Process Development Team		 José Luís Santos, Ph.D.

Director, Technology Intensification

 

​​​​Clara Sá Couto and José Luís Santos will describe the best practices to transition ASD formulations developed in the laboratory into a reliable industrial process, based upon proven methodologies for process development and scale-up, guaranteeing lean and material sparing approaches. 

The webinar will cover industry standard QbD principles, mathematical models and process development methodologies that benefit from extensive development and manufacturing experience. Existing lab assets will be presented, including a customized spray dryer that can mimic large scale powder properties. Finally, the speakers will guide you through a model-based methodology to establish a design space, to prepare the process for validation and commercial supply.

 

Your Key Learning Objectives: 

  • Understand what to consider for the process development and scale-up of ASD formulations manufactured by spray drying to gain a robust process for validation and commercial supply;
  • ​Discover how to develop an industrially reliable ASD formulation in the lab based on advanced mathematical model to be able to generate optimized process conditions that guarantee seamless scaling-up;
  • Learn how to leverage previous experience, databases, and mathematical models to improve process development and troubleshooting, and to establish an optimized design space to enable flexible manufacturing strategies.

 

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 developing and scaling-up an ASD by spray drying.

 

 

Watch On-demand. 

Gated content. Registration is required.

 

Do you have a challenging project needing differentiating technologies and an innovative approach?

Get in touch today

 

 

 

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The CDMO’s New Jersey manufacturing site expansion will eventually cover more than 200,000 square feet. Portugal-based contract development and manufacturing organisation (CDMO) Hovione has completed an initial $100 million investment round in its East Windsor, New Jersey site. Once completed it will increase the facility’s footprint to more than 200,000 square feet and more than double its capacity for spray drying. Hovione CEO Jean-Luc Herbeaux said: “Since launching our New Jersey operations in 2002, Hovione has been one of the longest established European CDMOs in the United States. “This investment reinforces Hovione’s leadership in spray drying – a core technology platform where we have built extensive know-how and capabilities. By continuing to advance our platforms and expand capacity in the US, we are strengthening the foundation that enables our partners to bring complex medicines to patients more efficiently.” Spray drying is an increasingly important particle engineering technology for improving drug bioavailability through the amorphous solid dispersion (ASD) that can address bioavailability or crystallisation challenges. The initial phase of Hovione’s expansion will include a 31,000-square-foot building to house two size-3 spray dryers (PSD-3) designed for ASD production. Construction at the New Jersey site is already underway and the company plans to start GMP operations in the second quarter of 2026. The initiative is part of Hovione’s long-term strategy to grow its US operations and enhance its integrated drug substance, drug product intermediate and drug product capabilities. Herbeaux said: “This investment addresses growing customer demand for US-based capacity and integrated solutions that shorten development timelines and reduce tech transfer complexity. By consolidating development, scale-up, and commercial manufacturing within a single quality and governance framework, we provide customers with seamless execution from drug substance to drug product.” The company’s New Jersey expansion fits into its wider international growth plan that also includes capacity investments in Ireland and Portugal as it seeks to create a network of autonomous sites spanning the development and commercialisation of APIs, drug product intermediates and drug products.   Read the full article at EuropeanPharmaceuticalReview.com  

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