As the number of poorly soluble molecules entering the pipeline has increased, the application of amorphous solid dispersions (ASD) development has grown. With the advent of next-generation ASD technologies, like KinetiSol™ Technology, drug developers are setting new standards in scalability, sustainability and performance.
Common manufacturing methods for amorphous solid dispersions (e.g., spray drying and hot melt extrusion) can present scale-up challenges such as feed rate and particle size variability between scales; flow and compatibility of the resulting amorphous solid dispersion; environmental impact of raw materials during processing and the heterogeneity and stability of feed solution. These factors can negatively impact product performance and manufacturability.
In this webinar, the expert speakers will share their scale-up experiences and perspectives on opportunities to improve technology transfers for amorphous solid dispersions. They will define best practices for a successful scale-up and a more complete and efficient tech transfer for the commercialization of amorphous solid dispersions.
Register for this webinar today to learn how scale-up challenges faced during the development of amorphous solid dispersions can be overcome.
Speakers
Dr. Justin Keen, PhD, Senior Vice President, Operations, AustinPx
Dr. Justin Keen has over 20 years of experience in pharmaceutical formulation development, process development, clinical manufacturing and process validation. As SVP, Operations, Dr. Keen leads AustinPx’s manufacturing, quality control, facilities and IT teams.
After earning his BS in Chemical Engineering from the University of Texas, Dr. Keen worked as a formulation scientist for DPT Laboratories and PharmaForm, LLC, where he gained wide experience in hot melt extrusion, blending, granulation, compression, encapsulation and clinical labeling.
Dr. Keen has supported process development and validation activities and has worked with over 30 new chemical entities for numerous formulation development and clinical supply campaigns. Dr. Keen earned his PhD in Pharmaceutics under the supervision of Professor James W. McGinity from the University of Texas at Austin.
Message Presenter
TJ Highley, MBA, CEO and Board Member, Microsize
TJ Higley brings 25 years of experience in the pharmaceutical market in various operational and customer facing roles. As the former owner and executive leader of Powdersize, Inc., the original CMO focused on pharmaceutical micronization in the US, TJ led both the business development efforts and oversaw the site quality team during his tenure culminating in the acquisition of the company by Capsugel in 2015 and the integration into Lonza in 2017.
With the recent buyback of the business, rebranded as Microsize, TJ continues to grow the business and has led the capability expansions in analytical characterization and manufacturing partnerships with additional novel BAE techniques, including AustinPx’s KinetiSol™.
Message PresenterWho Should Attend?
This webinar will appeal to Directors/Senior Directors/Vice Presidents working in pharmaceutical or biotech companies in the following fields:
- Drug Product Development
- Pharmaceutical Operations/Technology
- Process Chemistry/Formulation Development
- External Manufacturing
- Technical Operations
What You Will Learn
Attendees will learn about:
- The challenges in the ASD scale-up process
- Improvements in scalability from next-generation ASD technologies
- Best practices for a successful technology transfer
Xtalks Partner
AustinPx
Founded in 2007, AustinPx, Pharmaceutics and Manufacturing, is a fee-for-service CDMO offering preclinical through Phase II formulation and process development and GMP manufacturing of oral dosage forms. We specialize in bioavailability enhancement, speed to clinic and market development strategies, and dose form development.
The name AustinPx represents where we come from and what we do. Px stands for Pharmaceutics. To our core, we are a pharmaceutics company. Our approach is data-driven and agnostic which means our formulation strategy for each drug is based on the unique physiochemistry of that compound. And for poorly soluble compounds, we have one of the most powerful tools available in KinetiSol, a truly next generation technology for rendering active pharmaceutical ingredients amorphous.
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