Disposable bioprocessing technology is taking a step forward in a deal between platform- and service-provider Xcellerex and extracellular matrix tissue-maker Humacyte. Xcellerex will scale up production for Humacyte's regenerative medicine product using a single-use bioreactor system and bioprocessing platform to produce large-diameter vascular grafts.
The Humacyte process of growing grafts from sample tissue involves a lengthier and more complex process than that of most biopharma production processes. "Tissues take longer to grow," says Parrish Galliher, founder and CTO at Xcellerex, in an interview. "For organs and tissues, it's months. The bioreactor system has to be robust to work reliably for months at a time."
During development, the Humacyte process has run on traditional glass bioprocessing gear. The cells grow on a matrix that helps them form the vascular graft. "Cells for tissue grafts are more sensitive than the workhorse cell lines used to make drugs," says Galliher. "They require more sensitive controls for temperature, pH, oxygen levels and fluid shear."
Under the contract, Xcellerex is transferring the Humacyte process to the XDR single-use bioreactor system and FlexFactory platform. The service provider is building the portable production system at its location and perfecting the methodology for single-use production. Humacyte will use the grafts for preclinical development, and the deal may extend to large-scale manufacturing for clinical and commercial use.
- here's the Xcellerex release