Traditional sterility methods following USP and 21 CFR standards require extended incubation of up to 14 days, significantly delaying the quality control process in biopharmaceutical manufacturing.
The Mango M6 offers a rapid, compact, and automated solution, leveraging lens-less microscopy and machine learning to deliver results in hours while maintaining compliance with regulatory standards.
Significantly reducing microbial quality control time from days to hours, accelerating production timelines and improving responsiveness to public health needs.
By implementing real-time process monitoring and control systems in the Mango M6, an organization could reduce contamination-related losses by up to $57 million per fermentation run and $1–10 million per discarded chromatography lot, enabling significant material, product, and labor cost savings while ensuring faster and safer delivery of life-saving medicines to patients.
Enumeration study on pre-GMP and pre-production M6 instruments to verify accuracy, precision, linearity, limit of quantification and range
2 GMP-ready M6 instruments with updated hardware and software based on growth promotion testing
Creation and qualification for instrument (IQ), operation (OQ), and performance (PQ)
Final method validation reporting
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Mango Inc.
Janssen Research & Development, LLC
