Lonza has agreed to evaluate BaroFold’s high-pressure refolding technology for difficult to express microbial products expressed as inclusion bodies.
According to the non-exclusive agreement announced last week, BaroFold’s Pressure Enabling Protein Manufacturing (PreEMT) technology will be installed at Lonza’s microbial development and manufacturing plant in Visp, Switzerland. Lonza may extend its evaluation of the technology to cGMP manufacturing.
“During the course of the PreEMT technology evaluation, Lonza will be testing a number of microbially-expressed proteins where previous refolding and functionality challenges have already been identified using current refolding methods available on the market today,” Jason Spacek, associate director of business development at Lonza told in-Pharmatechnologist.com.
The PreEMT technology will be evaluated alongside Lonza’s existing XS Expression Technologies Platform, the combination of which offers more options for Lonza’s customers, Janet White, global head of Lonza’s custom manufacturing development services business unit, said.
Over the course of 2013, the company “will be investigating both solubilization and re-folding with intention to produce functionally active proteins,” Spacek added.
PreEMT technology contrasts with traditional protein refolding methods, according to BaroFold, and industry seems eager to test its abilities as more pharma companies and CMOs sign on to evaluate it.
“PreEMT refolding dissociates protein aggregates and refolds at conditions that favor the protein’s native conformation, which contrasts traditional methods requiring complete denaturation prior to refolding,” Matt Seefeldt, vice president of research at BaroFold, told in-Pharmatechnologist.com.
In November, Boehringer Ingelheim announced the same technology will be installed at its microbial facility in Vienna, Austria. Boehringer plans to make it available for development of biopharmaceutical production processes.
PreEMT also has been used to develop Nuron Biotech’s NU100, a recombinant human interferon beta-1b to treat patients with multiple sclerosis, which is currently in a Phase III clinical trial, Seefeldt said.
“Traditional methods decrease yields and require low protein concentrations as a result of reaggregation,” Seefeldt added, noting that PreEMT refolding “increases proteins concentrations (as high as 30 g/L), improves yields and throughput relative to traditional methods.”
He also noted that PreEMT can be “applicable in downstream processing, recovering difficult to purify aggregates and subvisible particles—improving patient safety by reducing drug immunogenicity.”