PBI expects that the Barofold technology platform will improve the quality and costs of manufacturing protein therapeutics, by helping to resolve protein aggregation, improving solubility, and refolding complex misfolded protein therapeutic molecules into their desired, therapeutically-optimized conformations for improved drug efficacy and lower immunogenicity.
Protein-based therapeutic drugs are a large and rapidly growing part of the global healthcare industry. There are over 200 therapeutic proteins and peptides approved for clinical use in the U.S. Protein therapeutics are valued for their more potent and specific therapeutic effectiveness for many diseases, such as cancer and auto-immune disorders. They are also the preferred treatment choices for hormone and growth factor deficiencies. Research and Markets (May 2016) forecasted that the global protein drug market will grow to $248 billion by 2020.
"The development and manufacture of protein-based drugs can be complex and fraught with difficulty,” said Alexander Lazarev, chief science officer, PBI. “According to a recent publication from a team of researchers from the U.S. Food and Drug Administration (Lagasse, Feb 2017), producing a typical protein drug may include more than 5,000 critical manufacturing process steps. High on the list of significant problems that can occur during manufacturing and storage of protein drugs are the formation of protein aggregates and the misfolding of the complex protein molecules into configurations that are therapeutically ineffective, undesirable, and even harmful. Our Barofold technology platform offers a unique and cost-effective processing strategy that is expected to be effective in addressing and resolving these expensive manufacturing challenges."