The Ontario, Canada-based firm manufactures viral, bacterial and parasitic products used in immunoassays, quality assurance and proficiency testing controls, and for vaccine and antiviral R&D.
These “antigens are made by cultivating the different organisms at scale under the appropriate biosafety conditions, purifying them, inactivating them, titrating and packaging them and performing a series of QA and QC steps to ensure consistency of product,” CEO Cameron Groome told Biopharma-Reporter.
“In the case of bacterial antigens, the organisms are cultured directly, in the case of viruses, host cells to the viruses must be grown before viral particles can be produced.”
While antigens are traditionally made using roller bottles, Groome said increased industry demand calls for a shift in production to bioreactors and as such Microbix has ramped-up its site in Mississauga.
“Roller bottle production requires a great deal of space, labour and materials. Microbix would have had difficulty meeting the emerging demand growth for the referenced product without this shift in technology. Its successful conversion to bioreactors should enable the company to capture growing global product demand.”
He added that while growing mammalian cells in bioreactors is a known process, many companies have failed at scaling up from roller bottles.
“Microbix has not only succeeded in the culturing of mammalian cells in bioreactors, but has also kept those cells alive while infecting them with a virus and obtained consistent quantity and quality of the desired viral antigen particles,” he said. “Our management has likened this to the difference between hitting a target with a bullet and hitting a bullet with a bullet.”
Microbix has not disclosed the type, scale and brand of bioreactors it has selected for its processes but is increasing bioreactor capacity by 500%, going from one production-oriented bioreactor to six for a top-selling – and undisclosed – product. All six units have been delivered and will enter production in early 2018.
The firm said it is also increasing its downstream processing capacity to support the expansion.