Beyond Amorphous Solid Dispersions: Novel Applications in Pharmaceutical Spray Drying

Join our panel of experts as they explore how spray drying can be applied to enhance the stability, bioavailability, and manufacturability of various molecules, including peptides, oligonucleotides, small molecules, monoclonal antibodies, and nutraceuticals.

Register Free: https://www.pharmtech.com/pt_w/beyond-amorphous-solid-dispersions

Event Overview:

Developers of innovative drug products dealing with protein formulations, nucleotide-based drugs, peptides, and poorly soluble molecules, face significant challenges in achieving efficient and scalable manufacturing solutions. Spray drying has emerged as a powerful and versatile manufacturing technology. It offers significant advantages for stabilizing complex and sensitive drug molecules while optimizing production processes.

Join our panel of experts as they explore how spray drying can be applied to enhance the stability, bioavailability, and manufacturability of various molecules, including peptides, oligonucleotides, small molecules, monoclonal antibodies, and nutraceuticals. This session will cover the latest innovations in spray drying technology, and provide valuable insights into formulation development, process parameters optimization, and large-scale production. Attendees will also learn how to maintain molecular integrity during the spray drying process and leverage in-silico tools to streamline commercialization.

Whether you’re working with small-scale experimental formulations or preparing for commercial manufacturing, this webinar will equip you with actionable strategies needed to optimize your development pipeline and succeed in spray drying applications.

Key Learning Objectives:

• Discover how spray drying extends beyond amorphous solid dispersions to tackle the stabilization and manufacturing challenges of complex compounds, including peptides, oligonucleotides, and biologics
• Learn effective strategies for scaling up spray drying processes from lab-scale to commercial production, while ensuring product consistency, cGMP compliance, and regulatory adherence
• Gain insights into advanced methods for analyzing spray-dried powders, including their particle size distribution, morphology, and flow properties, to ensure optimal performance of diverse pharmaceutical formulations beyond ASDs

Speakers:

Lisa Caralli
Senior Director, Scientific Advisory
Catalent

Lisa Caralli is senior director of scientific advisory at Catalent, overseeing small molecule and peptide scientific support for North America. She has over 30 years of industry experience in pharmaceutical research and development, with a focus on early-phase approaches to the chemistry manufacturing and control of small molecules and peptides. Caralli has held previous product development positions at Ionis Pharmaceuticals, Amylin Pharmaceuticals, and the Immune Response Corporation. She holds a bachelor of science in biochemistry from the University of California, Davis.

Nathan Bennette
Director, Scientific Advisory
Catalent

Nathan Bennette is the director of scientific advisory at Catalent. He is also a member of Catalent’s small molecule advisory team for North America. In this capacity he works directly with partners to understand the key drug delivery objectives for their specific molecule, collaborate on the target product profile, and define a strategy for the development program. He has over 15 years of experience in pharmaceutical development and delivery with an emphasis in bioavailability enhancement. Bennette is particularly interested in the application of the scientific method early in the design and development process, along with improving clinical outcomes by bringing a ‘right the first time’ approach to formulation and process design. He holds a master’s degree in inorganic and organometallic chemistry from the University of Washington.

Andrew Birkmire
Senior Process Scientist and OSD Manager
GEA

Andrew Birkmire is a senior process scientist and OSD manager at GEA. His responsibilities include all internal and on-site process testing and development for North American pharmaceutical applications. Birkmire’s background includes extensive experience in coating, drying, and granulation technologies, with a focus on continuous manufacturing processes.

Nima Yazdanpanah
Principal Consultant
Procegence

Nima Yazdanpanah is a consultant on advanced manufacturing and modeling and simulation applications in bio/pharmaceutical and fine chemical industries. His area of expertise covers process design and development, continuous manufacturing, process simulation, particulate matters, digitalization, and regulation. Prior to starting Procegence, his consultancy firm, Yazdanpanah was a research scientist with the US Food and Drug Administration. He was appointed as a member of an expert team for advancement of emerging technologies to modernize pharmaceutical manufacturing. With 20 years of diverse experience in different industries—including petrochemicals and specialty chemicals, food, and pharmaceuticals—he has worked in R&D, process design, and MSAT sections. At Procegence, he helps companies with process development, scaling-up, optimization, and tech transfer. He aims to bring his clients’ product to market faster, better, and at lower cost.

Trishul Shah
Director Global Sales and Marketing, Head of Sales, Americas
PolyPeptide

Trishul Shah is the Director of Business Development and Head of North American Sales for the PolyPeptide Group. He is involved in industry peer groups such as the TIDES Advisory committee, Boulder Peptide Symposium Scientific Board, a member of the PolyPeptide Group’s Executive Strategic Team in the US and member of the Global Management Group at PolyPeptide. Trishul joined the PolyPeptide Group as a peptide chemist in 2005 and in 2007 joined Allergan as a pre-formulation chemist. Upon returning to PolyPeptide in 2009, Trishul joined the Business Development group.

Register Free: https://www.pharmtech.com/pt_w/beyond-amorphous-solid-dispersions