Pressure BioSciences Inc (OTCQB:PBIO), a leader in developing high-pressure-based technologies for the life sciences market, announced Monday the commercial launch of its biopharmaceuticals contract services business.
The launch follows the South Easton, Massachusetts, company’s acquisition of BaroFold Inc's assets in December 2017 which included patents and equipment linked to Barofold's novel high pressure-based protein disaggregation and refolding platform.
The company expects its Barofold technology platform to improve the quality and costs of manufacturing protein therapeutics, by helping to resolve protein aggregation and improve solubility. The technology also helps to refold “complex misfolded protein therapeutic molecules into their desired, therapeutically-optimized conformations” for drug efficacy.
"The development and manufacture of protein-based drugs can be complex and fraught with difficulty. According to a recent publication from a team of researchers from the US 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,” said Dr Alexander Lazarev, chief science officer at Pressure BioSciences.
“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," he added.
Protein-based therapeutic drugs are a rapidly growing part of the healthcare industry. There are over 200 therapeutic proteins and peptides approved for clinical use in the United States. Protein therapeutics are valued for their potency in battling cancer, auto-immune disorders. The global protein drug market is estimated to grow to $248 billion by 2020, according to Research and Markets.
"In May 2018, we began applying the Barofold platform to help resolve a major challenge in the manufacturing process for a key protein drug candidate being developed by an Asian biopharmaceutical company. Based on the successful progress of our Barofold platform to date, this client recently expanded their initial request to now include other variations on their protein drug candidate,” said Dr Lazarev. “In addition, we have recently been approached by another multi-national biopharmaceutical company for help on a similar issue."
Pressure BioSciences focuses on the development of high pressure-based scientific instruments for biomarker discovery, drug design and development, food science, forensics and counter-bioterror applications.
Pleased to help first client
"We are excited to announce the launch of our biopharmaceutical contract services business for the disaggregation and controlled refolding of proteins. For companies involved in protein manufacturing, aggregation of proteins and challenges in achieving and maintaining optimal protein folding conformations are well-known issues that can dramatically reduce a drug's efficacy and shelf-life. Our proprietary, pressure-based Barofold technology platform can help resolve and optimize these outcomes and can enable the development of novel protein therapeutics in both mammalian and non-mammalian systems, which we believe to be a very large and growing market opportunity," said Dr Bradford A Young, chief commercial officer at Pressure BioSciences.
Young said the company was “very pleased” to be able to help its first client, a publicly-traded biotech company, in “improving their protein manufacturing processes using our proprietary Barofold protocols.”
“The early results were so encouraging in helping our client surmount difficult manufacturing challenges in the production of their protein therapeutic drug candidate, that they have now asked us to extend our Barofold work to include two additional protein drug candidates. In addition, improved pressure-based disaggregation and protein refolding protocols have become exciting new product applications for our core Barocycler™ instrument platforms, which were already being sold into biotechnology and pharmaceutical companies for quality control, as well as for biomarker or drug target characterization purposes,” said Young.
The company is banking on its biopharmaceutical contract services business to provide strong revenue in the year ahead.
Contact Uttara Choudhury at [email protected]