Press Room

Webinar - Amorphous Solid Dispersions by Spray Drying from Bench to Market

Start
Tuesday, June 30, 2020 - 16:00
End
Tuesday, June 30, 2020 - 17:00
Location: online

Tuesday, June 30th, 2020  |  8 AM (PDT), 11 AM (EDT), 4 PM (GMT)

 

Watch On-Demand Webinar

 

Speakers

Eunice Costa - Director, Drug Product Development
João Henriques - Group Leader, Drug Product Development

 

Amorphous solid dispersions are an established enabling platform for low solubility BCS class II APIs. Spray drying has emerged as the preferred platform for the manufacturing of ASDs. In this webinar we will provide an overview of the challenges and opportunities in developing amorphous spray dried dispersions (SDDs) from bench to market.

We will show how first principles and empirical models can be used to leverage and accelerate the development of optimized and scalable SDD formulations. Coupled with data-based oral formulation development strategies, we will also demonstrate how to accelerate development programs, minimize material consumption and reduce time-to-clinic.

Risk mitigation approaches coupled with the proper set of computation and statistical analysis, stemming from a robust early process development, will be presented as a strategy to a smooth the transition from clinical to commercial with minimal experimentation at scale, reducing development burden, material consumption and time-to-market.

In this webinar you’ll learn:

  • How to accelerate development of SDD formulations
  • Importance of integrated formulation/process development
  • Mitigate risks during SDD scale-up/development

Watch On-Demand Webinar

 

 

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With key expansions coming to fruition on either side of the pond, specialist CDMO Hovione is making sure that drugmakers can access its particle engineering expertise across multiple geographies.  That flexibility will be key for the Portugal-based company in the coming years as the pharmaceutical industry continues to embrace more regional supply chains. In a recent interview, Hovione's David Basile, VP of technical operations for the Americas, discussed this trend and the manufacturer's expansion project, which is set to come online in New Jersey next month.  In the coming weeks, Hovione plans to debut a new spray drying expansion at its campus in East Windsor, New Jersey. The company has invested $100 million to expand its campus, including new construction and the acquisition of an additional facility and greenfield land.  Specifically, one of two pharmaceutical spray drying-3 units, or PSD-3 units, will come online in the coming weeks to tackle amorphous active pharmaceutical ingredients (APIs) and amorphous solid dispersions, according to the company. With some 80% of new small molecules in development insoluble in water, Hovione’s particle engineering and amorphous solid dispersion platform helps medicine developers improve the solubility, bioavailability, and, in some cases, the stability of their drug candidates, Basile said.  The company boasts spray dryers from the lab scale to PSD3 at its original facility in East Windsor, in addition to the pair of large-scale machines about to be activated at the campus' new facility.  “We’re going for a single, unified site with capabilities across the campus to do drug substance through finished drug product under one governance and quality system,” - Basile told Fierce.   Read the full article at FiercePharma.com

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