Scale-Up and Commercialization of Spray Dried Amorphous Solid Dispersions

Life Sciences, Pharmaceutical, Commercialization & HEOR,
  • Thursday, May 27, 2021 | 1pm EDT (10am PDT)
  • 60 min

Spray-drying is a preferred process for manufacturing amorphous solid dispersions to provide oral bioavailability enhancement for low-solubility small molecules, which represent approximately 70% of the new chemical entity pipeline. A robust, efficient scale-up process that ensures critical-to-quality attributes (CQAs) are maintained is crucial to the commercial viability of these molecules.

This webinar focuses on manufacturing aspects of amorphous spray-dried dispersions (SDDs) to enable successful scale-up and optimization of the process. An overview of spray-drying and typical scale-up challenges will be presented along with methodologies that enable rapid scale-up that is right the first time from clinical to commercial scale.

Register for this webinar to hear the details of a case study demonstrating a scale-up approach for compounds that have favorable bioavailability when using the SDD platform, however, scalability is constrained due to limited compound solubility in typical processing solvents. For these compounds, one proven approach is to use a superheated solution spray-drying process to enable batch scale-up or to avoid less desirable processing solvent options.

Speakers

http://Logan%20Howell,%20Lonza

Logan Howell, Engineer III, Lonza

Logan Howell is an Engineer III at Lonza in Bend, Oregon. He works in the late stage product development group, primarily focusing on the scale-up and optimization of spray drying processes. He also has extensive experience with process validation and continuous process verification (CPV) for commercial manufacturing operations. He graduated with an MS in chemical engineering and an MBA from the University of Tennessee.

Message Presenter
http://Joel%20Wood,%20lonza

Joel Wood, Engineer III, Lonza

Joel Wood is an Engineer III at Lonza in Bend, Oregon, where he focuses on late stage process and product development. During his time at Lonza he has worked primarily in the areas of spray drying process scale-up, control strategy development, and technology transfer of late-phase clinical and commercial products. He received his Bachelor of Science degree in chemical engineering from Bucknell University.

Message Presenter

Who Should Attend?

  • Large pharma, mid-size pharma, biotech companies, consultants
  • Technical positions involved in process development and scale-up, early- to late-stage development, or commercialization
  • Senior managers, scientists, engineers, R&D managers

What You Will Learn

In this webinar, participants will learn about:

  • Spray-drying process optimization techniques
  • Methodologies for scale-up from clinical to commercial phases
  • A risk-based approach to maintaining critical-to-quality attributes for amorphous spray-dried dispersions
  • Successful commercialization of a novel spray-drying process

Xtalks Partner

Lonza Pharma & Biotech

At Lonza Pharma & Biotech, we provide development and manufacturing services that enable biopharma companies to bring small molecule medicines to patients in need.

From drug substance to the final drug product, our solutions feature enabling technologies to successful advance your molecule, and concept to commercial services to simplify your outsourcing experience. Our extensive track record includes development and manufacture across a wide range of drug substances, particle-engineered intermediates and specialized drug products for oral solid, parenteral and inhaled delivery routes. We continuously invest to solve not just current, but also future challenges that support the development and commercialization of pioneering therapies.

Together, we can bring your next medicine to life.

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