System for RAPID Testing of BIOBURDEN or STERILITY with Automated Imaging

Mango has a technology for detecting microbial growth in hours that is non-destructive of the sample; the electronic Petri dish, or ePetri. This project will update the consumables, design, & software and demonstrate performance of ePetri.
Categories
Proteins/ Antibodies
Cell and Gene therapies
Assays
Active Immunization Countermeasures

Industry Need

  • While sterility and bioburden testing are essential to the quality control process for biopharmaceuticals, it can often take significant time to generate results. 
  • Pharmaceutical microbiologists and the entire supply chain often must wait from days to weeks for results, creating a bottleneck in biomanufacturing and the release process.  

Approach

Mango has an exclusive licensed based technology detecting microbial growth in hours that is non-destructive of the sample: the electronic Petri dish, or ePetri.  

  • ePetri is an automated method for detecting growth and counting individual microorganisms on the surface of an agar-containing plastic consumable. Using sophisticated lenseless image capture and analysis, microbiologists can quickly count micro-colonies emerging from culturable individual microbial cells (i.e., growth-based technology) within a few hours, a full 1 to 3 days sooner than is possible by means of the naked eye.  
  • ePetri uses the same media, filters, plastics, and visual readout that the industry and regulators have trusted for 75 years.  
  • ePetri has the potential to revolutionize how biopharmaceutical bioburden and sterility tests are performed.  

Impacts

Reduce sterility testing time for intermediate monitoring and finished product release

Improve quality control and quality assurance for products that cannot be subjected to in-process sterile filtration

Value Statement/Outcomes

By implementing Mango’s automated imaging system for rapid bioburden and sterility testing, an organization can reduce time-to-result bottlenecks in microbial quality control from days to hours, enabling faster, safer, and more efficient biopharmaceutical manufacturing.

Outputs/Deliverables

Reduced time to results for visualizing microbial growth from days to hours.

Patented technology eliminated need for external incubators.

Posters

Davis, C., NIIMBL PC4.1-137: Mango's System for RAPID Testing of BIOBURDEN or STERILITY with Automated Imaging, NIIMBL National Meeting, Washington, DC, July 26, 2022.

Davis, C., Presenter, PC4.1-137: Mango's Automated Compendial Near Real-Time Platform – A Revolution in Microbial Quality Control, NIIMBL National Meeting, Washington, D.C., July 26, 2022.

Ross, R., PDA Poster Session, PDA Rapid Microbiology Methods Workshop, Washington, DC, October 13, 2022.

Presentations

Davis, C., Resolution of 1 E. coli Cell Emerging into a Viable Microcolony in as Little as 4 Minutes, NIIMBL Member Forum, Virtual, August 25, 2022.

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Project Lead

Mango Inc.

Mango Inc.

Participating Organizations

Janssen Research & Development, LLC

Janssen Research & Development, LLC