Producing dry biopharmaceutical products via spray drying shows promise for increasing stability.
By Nishan K. Shah, Ph.D., and Samantha A. Meenach, Ph.D., both at the University of Rhode Island
A biological therapeutic (biopharmaceutical) is a protein, nucleic acid, peptide, or related biological entity used in the treatment of chronic and acute disease states.1,2 In 1982, human insulin became the first Food and Drug Administration-approved biological product, and since then numerous biologically based products have been approved, for example, for cancer, autoimmune diseases, and infectious diseases.1,3,4 Because of their potential for target selectivity and/or potency, biopharmaceutical products are rapidly escalating as therapeutic and preventative options. However, because of their complex structures (folding, exposed residues, hydrophobic and hydrophilic sites, etc.), biopharmaceuticals often exhibit instability and need to be handled with care, particularly when in the liquid state.5–8 Due to their molecular mobility in liquid state, biopharmaceuticals have the freedom to interact with one another, allowing for aggregation between molecules.5,9,10 Additionally, biopharmaceuticals dispersed in liquid can experience chemical instability and denaturation through misfolding over relatively short periods of time.11 These issues can lead to decreased activity, while also increasing toxicity and immunogenicity.6 As a result, biopharmaceuticals must be kept in cold chain conditions (environment of 2–8°C) to maintain stability and prevent adverse events.12 Although effective, the sole use of cold chain is not entirely effective in maintaining a long shelf life for biopharmaceuticals. For example, disruption to the cold chain is responsible for the loss of half of all developed vaccines.3,12 Cold chain also presents an economic burden, especially in resource-poor countries where maintaining cold chain temperatures is exceptionally difficult and infeasible.1,12