Press Room

Event

Webinar: Commercial Reality and Lifecycle Management of ASDs

Start

Thursday, April 20, 2023 - 16:00

Location: online

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

Thursday, April 20th

4:00pm GMT | 11:00 am EDT | 5:00 pm CEST

Registrations to the webinar are subject to approval.

Watch On-demand.

Gated content. Registration is required.

Featured Hovione experts in this webinar

Inês Salsinha, M.Sc. Quality Assurance Specialist Site QA	Tiago Porfirio, Ph.D. R&D Manager, Particle Engineering Corporate Technical Services

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.

Watch On-demand.

Gated content. Registration is required.

Are you looking for a clear path from formulation screening to commercialization?

As an experienced manufacturer of ASDs by Spray Drying, Hovione will support your project by combining modeling capabilities, extensive process knowledge, and manufacturing capacity with an unmatched approval track record.

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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