The Yamato HUBBLE — the AdvSHENTEK Mycoplasma DetectInnova System — is a rapid, fully automated, highly sensitive platform for detecting mycoplasma contamination in cell cultures and biopharmaceutical products. It transforms the rapid microbiological method (RMM) into a streamlined, portable benchtop system: integrated nucleic-acid extraction plus real-time PCR delivers a sample-to-result turnaround of about 2.5 hours (manufacturer cites 2.5–3 hours) with under 5 minutes of hands-on time, and it requires no specialized DNA-extraction or PCR expertise to operate. Using magnetic-particle separation and probe-based real-time PCR, it reaches a limit of detection of 10 CFU/mL and complies with pharmacopoeia EP 2.6.7.
Key Specifications
| SKU | HUBBLE |
| Product | AdvSHENTEK Mycoplasma DetectInnova System |
| Method | Rapid microbiological method (RMM) — automated nucleic-acid extraction + real-time PCR |
| Detection chemistry | Magnetic-particle separation + probe-based real-time PCR |
| Limit of detection | 10 CFU/mL |
| Time to result | ~2.5 hours (2.5–3 h) sample-to-result |
| Hands-on time | Under 5 minutes |
| Species coverage | 180+ species incl. Mycoplasma, Spiroplasma, Acholeplasma (manufacturer cites up to 200+) |
| Compliance | Pharmacopoeia EP 2.6.7 |
| Operator expertise | No specific DNA-extraction or PCR expertise required |
| Consumable | Closed, disposable DetectInnova Cassette (sample-to-result) |
Application Profile
Mycoplasma contamination is the silent failure mode of cell culture and biomanufacturing — these wall-less bacteria are too small to see by standard microscopy, pass through common 0.2 µm filters, and can quietly alter cell behavior and invalidate results or entire product lots. The regulatory answer, the traditional culture-based compendial test, takes up to 28 days — an impossible timeline for release testing of short-shelf-life cell therapies. That gap is exactly what the Hubble closes: an RMM that returns a validated answer in hours, not weeks, with a sensitivity (10 CFU/mL) and pharmacopoeia compliance (EP 2.6.7) that support it as a rapid alternative.
The workflow is deliberately deskilled. Sample goes into a closed, disposable cassette that carries all reagents; the instrument performs magnetic-particle nucleic-acid extraction and probe-based real-time PCR automatically, so an operator needs under 5 minutes of hands-on time and no molecular-biology background. Broad species coverage — 180+ mycoplasma, Spiroplasma, and Acholeplasma species — means one assay covers the contaminants that matter for cell-therapy release testing, biopharmaceutical QC, and routine culture monitoring.
Frequently Asked Questions
How fast is mycoplasma detection with the Hubble? About 2.5 hours sample-to-result (manufacturer cites 2.5–3 hours), versus up to 28 days for the traditional culture-based method — with under 5 minutes of hands-on time.
How sensitive is it? Its limit of detection is 10 CFU/mL, using magnetic-particle separation and probe-based real-time PCR.
How many species can it detect? Over 180 species (the manufacturer cites up to 200+), including Mycoplasma, Spiroplasma, and Acholeplasma.
Is it compliant with pharmacopoeia requirements? Yes — it is compliant with EP 2.6.7, supporting its use as a rapid microbiological method for release and QC testing.
Do I need PCR or molecular-biology expertise to run it? No. It is a fully automated sample-to-result system using a closed disposable cassette, requiring no specific DNA-extraction or PCR expertise.
What is it used for? Detecting mycoplasma contamination in cell cultures and biopharmaceutical products — cell-therapy release testing, biopharma QC, and routine culture monitoring.
Ordering & Configuration
Confirm at quote: DetectInnova cassette supply and throughput, your validation/compliance requirements (e.g. EP 2.6.7 documentation), and sample-type compatibility.
Warranty: Per Yamato standard capital-equipment terms — confirm coverage at quote.
Add to a quote to lock configuration, cassettes, and lead time.
Positioning: the HUBBLE is chosen when mycoplasma testing must be fast, sensitive, and compliant — a ~2.5-hour, 10 CFU/mL, EP 2.6.7-aligned RMM that replaces the 28-day culture test with a closed, deskilled, sample-to-result workflow. It is the release- and QC-testing answer for cell therapy and biopharmaceutical manufacturing where the traditional method is simply too slow.
