Application Note: Applicability of the LyoCapsule Mini Freeze Dryer for Pharmaceutical Product Formulation and Process Development
27 November 2017
The development of biopharmaceuticals often requires lyophilized formulations to produce stable drug products. Development of a drug formulation and lyophilization (freeze drying) process begins with laboratory experiments followed by scaleup to larger lyophilizers. A challenge during formulation and process development is the limited supply of and cost of producing sufficient Active Pharmaceutical Ingredient (API). Significant amounts of API may be required to properly screen formulations for freeze drying feasibility, understand critical product attributes, and define product and process design space to create a robust freeze-drying process.