MantaBio

The Cost of Slow QC

A multi-trillion dollar industry limited by retrospective testing.

Every wasted batch, every day of line-down time, every delayed release — those costs aren't theoretical. They're booked annually.

$12B

Annually Discarded Product

Biologics scrapped each year because QC arrived too late to release short-shelf-life therapy.

$1–2M

Per Day of Line-Down

When a contamination event hits, lines can stall for weeks while traditional testing rules out the source.

>750

FDA Recalls Per Year

Drug product recalls every year — many traceable to contamination events that earlier QC would have caught.

Sources: FDA Enforcement Reports, Cell & Gene Therapy Insights 2025

The Platform

An automated industrial QC system, built for sterility from day one.

From bioreactor floor to point-of-care manufacturing site, MantaBio replaces hours of skilled manual labor with a closed, automated, single-cartridge workflow engineered to meet sterility-grade requirements.

01 / SPECIFICITY

Single-use Cartridge

No human exposure. No technician contamination. The largest source of false positives, eliminated by design.

02 / SPECIFICITY

Viability PCR

Proprietary chemistry distinguishes living organisms from background DNA. Patent filed.

03 / SENSITIVITY

1–20 mL Sample Volume

Roughly 10× the input of conventional PCR systems — engineered to meet regulatory requirements. Contact us for sample volumes exceeding 20 mL.

04 / SENSITIVITY

4-Phase Sample Prep

Multi-stage extraction tuned for the lowest commercially viable limit of detection.

05 / SPEED

Fully Automated

Under five minutes of hands-on time. Load the cartridge, walk away, get sterility-grade answers in 2.5 hours.

06 / SPEED

Deployable Anywhere

At the manufacturing line. At the clinic. At the point of care. Wherever the sample is taken.

Unlocking Actionable Data

Faster. More sensitive. Uncontested.

Existing rapid methods either lack sterility-grade sensitivity or can't deliver in time. MantaBio is the only platform in the speed-and-sensitivity zone.

Each run takes under 5 minutes of operator labor.

No skilled-technician bottleneck. Scale linearly with your throughput — add cartridges, not headcount.

How It Works

Four steps. 2.5 hours. Under five minutes of your time.

Sample taken

Collect

Pull a sample from the bioreactor, manufacturing line, or clinic.

<5 minutes hands-on

Load

Drop the single-use cartridge into the system. End to end.

~2.5 hours, walk away

Run

Press start. Walk away. Fully automated processing.

Before shift ends

Decide

Actionable results when you need them. No more retrospective data.

Assay Menu

Contamination control and release decisions on one platform.

The MantaVision Automated vPCR Platform is suitable for qualitative applications across release and in-process testing:

Sterility

Total bacteria and fungi in a single assay.

Mycoplasma

~120 strains of Mycoplasma and related species.

Viral Adventitious Agent

Detection of viral contamination in cell cultures and bioreactor lines.

Residual Host Cell

Quantitation of host cell nucleic acid in purified product.

Monocyte Activation

Pyrogen testing alternative to LAL.

Specific Organisms

Targeted panels for known process- or facility-specific risk organisms.

Rapid ID Multiplex Panel

Single-run detection of the most common bioprocessing contaminants.

Cleaning Validation

Verification of microbial removal after sanitation and CIP cycles.

Other Common PCR Assays

Custom and off-the-shelf assays supported on the same platform.

Need an assay that isn't listed, or sample volumes exceeding 20 mL? Contact us.

Specifications

MantaVision target profile.

Refined from industry feedback to deliver broad assay panels at the sensitivity sterile manufacturing requires.

Operator loading a single-use cartridge into the MantaVision instrument

18" × 16" × 12" · footprint 35 lbs · weight

Time to Result

~2.5 hours

Hands-on Time

< 5 minutes

Sensitivity

< 10 CFU/mL

Sample Volume

100 µL – 20 mL standard cartridge · 100 mL+ available¹

Mode of Detection

Qualitative PCR (qPCR)

Sample Types

Filterable samples
Cellular-based samples (eukaryotic cells, live vaccines, etc.)
Radioligands

Applications

Sterility (presence / absence of bacteria & fungi)
Total Bacteria (~95% coverage)
Total Fungi (~95% coverage)
Total Mycoplasma (~120 species)
Most common viruses
Other common PCR assays

21 CFR Part 11

Compliant

Process Controls

Internal control integrated in cartridge · external positive & negative controls provided

Operator

Non-technical personnel

¹ Contact us for sample volumes exceeding 20 mL.

Leadership

An experienced and passionate team.

Deep expertise in automated PCR, biopharma operations, and rapid microbial detection.

Dr. Jack Regan

Co-Founder · CEO & CTO

Inventor of the MantaVision system. Previously led pathogen, cancer, and neurology assay development at Bio-Rad after helping QuantaLife bring droplet digital PCR to market (acquired by Bio-Rad for $162M). Post-doctoral work at Lawrence Livermore National Laboratory on the U.S. BioWatch program. PhD, UCSF.

Carter Boisfontaine

Co-Founder · President

Investment and operations professional with $500M+ in transactions across venture, growth, and corporate development. Previously led growth-stage investing at Pegasus Tech Ventures and corporate development at Bird Global, closing $200M in private financing and the company's SPAC merger.

Bill Puent

VP of Business Development

25+ years commercializing rapid testing across biopharma manufacturing, food & beverage, clinical, and life sciences. Senior leadership at Lonza Biosciences, Veolia, Alpha Wassermann, and Marshfield Health Systems. Co-founder of Sentinel Monitoring Systems (acquired by Veolia).

Drug safety results in 2.5 hours.
Not two weeks.

Manufacturing decisions happen in hours. Sterility tests take weeks.