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.
