MantaVision System
The MantaVision System provides actionable results at the point-of-need where samples are collected. MantaVision quickly detects the presence or absence of viable microorganisms in sample volumes up to 100mL1 in <2 hours.
MantaVision System
MantaVision is an automated, open-access molecular monitoring system for detecting the presence or absence of viable microorganisms and viruses in under 2 hours, providing users with timely, actionable contamination monitoring results.
Technology Overview
A brief overview of how the technology of MantaVision System to give MantaBio the best opportunity to succeed in this very attractive market is provided below.
Detection Range
The MantaVision System is able to detect up to 24 targets using qPCR and is being designed to detect > 95% of all possible bacterial, fungal, viral, or mycoplasma contaminants.
Sensitive Detection
Biopharma contamination testing requires samples to be tested to 10 colony forming units / milliliter (CFU/mL). Our team at MantaBio is making appropriate modifications and enhancements to allow for improved sensitivity.
Easy to Use
Hands-on time <1 min with integrated sample preparation and easy to interpret results.
How it Works
Fully automated PCR system that provides a digital readout.
System Configuration
Scan and insert PCR reagents and sample preparation buffers, which are stable on-system for six weeks
Hands on time < 1 minute
- Load sample into single-use disposable cartridge
- Scan cartridge barcode and insert into the system
Automated Run-time
- Contaminants are concentrated on a filter and lysed
- Nucleic acids (DNA and RNA) are purified and combined with PCR reagents
- Semi-quantitative PCR occurs and these data are analyzed
- A digital readout is delivered into a laboratory information management system (LIMS)
- The MantaVision System Test Specifications
MantaBio’s system will offer 4 broad tests to meet customer requirements.*
- Total Bacteria Test (Will detect ~95% of all known Gram+ & Gram– bacteria)
- Total Fungi Test (Will detect > 95% of all known fungi)
- Total Mycoplasma Test (Will detects ~120 strains of Mycoplasma and related species)
- Common Virus Test (Will come in two varieties)
- 4 viruses documented to have caused contamination in CHO cells
- 5 viruses documented to have caused contamination in human and primate cells
Every sample is processed using a disposable microfluidic consumable.* The development of these tests will be staggered such that MantaBio can get to market as quickly as possible with the most desirable test.
- Specifications and Target Profile
Based Industry feedback, the target profile for MantaVision has been refined to account for broad test panels at the required sensitivity.
Size (WxLxH) Small footprint and easily shipped (11″x 15″x 15″) Weight 30 lbs Total Targets Screened Total Bacteria Test (~95% coverage),
Total Fungi Test (> 95% coverage),
Total Mycoplasma Test ( ~ 120 coverage),
Most Common Viruses TestMode of Detection Semi-quantitative PCR (qPCR) Designed to handle CHO cells at 25 million/mL Yes Volume of sample processed 1,000 – 10,000 uL Time-to-Result ~2 hrs Hands-on-Time < 1 min (can be operated by non-technical personnel) Sensitivity <10 CFU/mL 21 CFR Part 11 compliant Yes Internal process control integrated in cartridge Yes External positive and negative controls provided Yes
“[Delayed Microbial Results are] the number one bottleneck to achieving real time release.”
– Head, Process Analytical Technology>
“We need to give the people on the manufacturing floor the ability to make processing decisions.”
– R&D Supervisor
“Rapid detection of the presence or absence of contaminants is critical in short-shelf-life products. We need an automated solution that eliminates sampling contamination.”
– PAT CoE Team Leader
MantaVision’s automated cartridge PCR minimizes contamination risk and is suitable for use at-line, near-line, or offline.
| Compendial culture-based tests | Standard PCR | MantaVision System | |
| Turnaround time | 5-28 days | 1-2 days* | ~2 hrs |
| Hands-on time | Moderate | Moderate | 1 min |
| Personnel experience | Moderate | Significant | Minimal |
| Use Case | Offline, near-line | Offline, near-line | At-line, Near-line, Offline |
| *3 hrs processing time |
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1 Sample sizes exceeding 10mL will require a 5-minute concentration step.