Mr. Cameron Groome reports
MICROBIX EXPANDING QAPS PRODUCTION CAPACITY
Microbix Biosystems Inc. has begun a buildout of its second facility that is initially intended to support a tenfold increase of production capacity for its QAPs -- quality assessment products -- which support the accuracy of clinical laboratory testing including, but not limited to, support for tests for the SARS-CoV-2 virus causing COVID-19 disease.
Microbix's current maximum QAPs production capacity is limited by the space allotted in its wholly owned facility that is primarily dedicated to making its range of antigens for immunoassay/serological test production. That capacity will be exceeded if Microbix achieves its growth objectives for QAPs.
The capacity expansion now under way is taking place at Microbix's adjacent administrative, production and warehousing facility. This second site was first occupied by Microbix in May, 2019. From that time, the express intent has been to dedicate a portion of its space for greater production of swab and vial-based QAPs -- initially built and equipped for scaled-up manual-based production and subsequently moving to full-scale automation for far greater productivity, all under ISO-13485 standards.
The initial manual process-based scale-up will provide 10 times the space that is currently dedicated to QAP production at Microbix's owned facility. It will comprise contained areas dedicated to formulation, filling or coating, capping or sealing, labelling, and final packaging of QAPs products. Additional and fully dedicated quality control laboratory spaces are also being created to support the greater QAPs production. The new spaces will be added to existing establishment licences with Health Canada and the U.S. Food and Drug Administration (FDA) once completed and validated.
The expansion is being financed from part of the proceeds of Microbix's private placement financing of January, 2020. Further assistance is being provided by the FedDev Ontario program of the government of Canada, as announced in July, 2019. The total cost of this initial phase of Microbix's QAPs production expansion is estimated at $825,000, and is expected to be completed by the end of August, 2020, with validation and commissioning undertaken as soon as possible thereafter.
Ken Hughes, chief operating officer of Microbix, commented: "It has never been more important to ensure the integrity of clinical laboratory testing programs. We are therefore pleased to offer even greater support to public health in Canada and internationally by expanding our QAPs production capabilities. We thank our dedicated team for helping drive this expansion, along with our general contractor Meadowbrook Construction of Mississauga, and our subcontractor ProPart Modular of Burlington. We also thank our many shareholders, TD Bank and FedDev Ontario for their steadfast support."
Microbix supplies a broad range of white-labelled QAPs, including other viral respiratory pathogens, to support proficiency testing (PT) programs of lab accreditation organizations in North America, Europe, Scandinavia and Australia. Under its PROCEEDx brand, Microbix provides RUO (research-use-only) QAPs to support the test validation/verification and operator training objectives of test developers and clinical labs. Full QMS support of clinical laboratory patient sample testing is provided by Microbix's REDxFLOQ or REDx Controls brand QAPs. Through distribution partners, D.I.D., Labquality, MSC and R-Biopharm, the PROCEEDx and REDx brands of QAPs are being made available in 21 countries.
About Microbix Biosystems Inc.
Microbix develops proprietary biological and technology solutions for human health and well-being, with approximately 80 skilled employees and sales now usually exceeding $1-million per month on average.
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