Rapid Bioburden and Sterility Testing for Biopharmaceutical Manufacturing

This project aims to develop and validate the Mango M6, a transformative system that addresses critical bottlenecks in biopharmaceutical manufacturing associated with bioburden and sterility testing.
Categories
Proteins/ Antibodies
Process control

Industry Need

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.

Approach

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.

Impacts

Significantly reducing microbial quality control time from days to hours, accelerating production timelines and improving responsiveness to public health needs.

Outputs/Deliverables

  • 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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Project Lead

Mango Inc.

Mango Inc.

Participating Organizations

Janssen Research & Development, LLC

Janssen Research & Development, LLC