Webinar: Spray Dried Biologics: Formulation and Process Considerations

Sponsored by: Capsugel

Focused on:

  • Spray Dried Biologics
  • Formulation

Date: 11 April

Days to go: 13

Time: 4PM London/11AM New York/8AM San Francisco

Spray drying is a precedented method for the continuous manufacturing of engineered dry powder particles from a liquid feed solution. The process is readily tunable and scalable which allows for rapid formulation screening, using a small amount of active, while also directly translatable to cGMP manufacture. Given these attributes the technology is applicable to formulating and processing biotherapeutic products.

This webinar will address why one would spray dry biologics and the key aspects for engineering a particle to meet the selected target product profile (TPP). Specifically we will cover; identifying a problem statement, why spray drying is enabling, defining important Active Pharmaceutical Ingredient (API) properties, formulation approaches, rationale excipient selection, how formulation impacts process, process scale-up and discuss a short case study that provides an experimental overview.

By spray drying biologics it allows for product delivery through various routes including; inhalation, oral, subcutaneous and even intravenous use when properly reconstituted. In addition, the powder can also be used as a bulk intermediate to avoid cold chain storage. Formulation and process attributes can be generic or specific to ensure stabilization and delivery of products. Spray drying is a robust, tunable, scalable and an enabling technology for bio-therapeutic product development.

Presented by

Michael Burke,

Sr. Scientist – Product Development

Michael Burke is a Senior Scientist at Capsugel and has been with the company since 2010. He has expertise in spray dried formulation approaches for biologics. In addition, he is well versed in the analytical characterization of macromolecules as well as the understanding of their drug stability mechanisms.

He graduated with a MS in Biochemistry from University of California Irvine, and a BS in Molecular Biology from the University of California San Diego.

Key Learning Objectives

  • Show why spray drying is applicable and enabling for biologics
  • Understand spray drying formulation considerations
  • How to tune the spray drying process to biologics
  • Delivery options for spray dried biologics

Audience

  • Formulation Scientist
  • Head of Development
  • Head of Product Development
  • Head of Pharmaceutical Sciences
  • Director Formulation
  • Director Formulation Development
  • VP Pharmaceutical R&D