PI: Dr. James T. Hsu
Co-PI(s): Dr. Lori Herz
University: Lehigh University
Production of biologics is an expensive process, and to optimize capacity use, bulk protein solution is often produced in manufacturing campaigns. It is converted into drug product based on market demand, and therefore may have to be stored for relative long periods. To decouple the bulk drug product, bulk is often stored frozen.
Transport of frozen bulk product between sites offers several advantages of transport in the liquid state (2-8 C). Maintaining 2-8 C requires accurate control systems to ensure that a product does not get too cold and partially freeze. A liquid shipment also subjects protein to greater degrees of agitation stress at air-liquid interfaces. Therefore, a successful bulk storage program will enhance bioprocess capacity use and reduce overall cost of production. However, success requires careful consideration of biophysical and engineering principles in development of a frozen-storage operation and its impact on the product to be frozen.

Publicly available information suggests that nearly half of commercial biotherapeutics are stored frozen. Given the high value of product being processed in the freezing operation, it is surprising that there is little scientific guidance available for practitioners. Literature on the impact of protein freezing is limited to very small-scale experiments that, although useful, do not address complications created by the relatively large heat and mass transfer dimensions of practical large-scale systems.
The objective of this project is to explore the basics of freezing biologics relevant to large-scale processes; to critically to examine some technologies and systems available to provide guidance on rational development of this unit operation; and to develop the novel coolants for rapid freezing of the biologics.