Microbix Expanding QAPs™ Production Capacity
Build-out to Support Tenfold Increase Now Underway
MISSISSAUGA, CANADA, May 27, 2020 - Microbix Biosystems Inc. (TSX: MBX, Microbix®), an award-winning life sciences innovator and exporter, announces that it has begun a build-out 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 underway 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 ten-times the space that is currently dedicated to QAPs production at Microbix's owned facility. It will be comprised of contained areas dedicated to formulation, filling or coating, capping or sealing, labeling, 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 licenses with Health Canada and the U.S. Food and Drug Administration (FDA) once completed and validated.
The expansion is being funded 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 $0.825 million, and is expected to be completed by the end of August, 2020 with validation and commissioning undertaken as soon as possible thereafter.
Ken Hughes, COO 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 sub-contractor 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-labeled 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 REDx®FLOQ 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
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. It makes a wide range of critical biological materials for the global diagnostics industry, notably antigens for immunoassays and its laboratory quality assessment products (QAPs™) that support clinical lab proficiency testing, enable assay development and validation, or help ensure quality control of clinical diagnostic tests. Microbix antigens and QAPs are sold to many customers worldwide, at present primarily to multinational diagnostics companies and laboratory accreditation organizations. Microbix is ISO 9001 and 13485 accredited, FDA and Health Canada establishment licensed, and provides CE marked products.
Microbix also applies its biological expertise and infrastructure to develop other proprietary products and technologies, most notably Kinlytic® urokinase, a biologic thrombolytic drug used to treat blood clots.
Microbix is a publicly-traded company, listed on the Toronto Stock Exchange and headquartered in Mississauga, Ontario, Canada.
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