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Scientist working inside a viral clearance laboratory
Viral Clearance & Biosafety CRO

Nothing reaches a patientuntil someone provesit is safe.

SynCRO runs the viral clearance, potency, and biosafety testing that turns your process into evidence a regulator can accept. Formerly Texcell North America, backed by a global virus safety group that has run viral clearance studies since 1990.

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10,000+
Viral clearance studies run across the group since 1990
BSL-2 / BSL-3
Containment on site
35 years
Of virus safety work
5 sites
North America, Europe, and Asia
What we do

Four services. One safety story.

Most sponsors come to us for viral clearance. They stay because the potency, production, and analytical work sits under the same roof, run by the same people, on the same timeline.

01
Viral Clearance and Virus Safety

Viral Clearance and Virus Safety

We evaluate how your process removes or inactivates virus, and we build the data package that shows it. GLP clearance studies, investigational and non-GLP studies for processes that are not locked yet, virus panel selection, and worst case condition evaluation across inactivation, chromatography, and filtration steps.

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02
Potency Assays for Plasma-Derived Products

Potency Assays for Plasma-Derived Products

Cell-based potency testing for plasma-derived immunoglobulin products, including measles virus and poliovirus assays against the CBER 177 reference standard and diphtheria toxin against NIBSC 10/262. Matrix assessment first, so toxicity and interference surface before they cost you a run.

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03
Virus Production and Virus Stocks

Virus Production and Virus Stocks

Small and large scale BSL-2 virus production, from roller bottles through 10-tier cell factories. Concentration by tangential flow filtration, ultracentrifugation, or PEG precipitation. Working virus bank generation inside the same workflow, plus viral stocks for reference standards and controls.

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Analytical and Safety Testing

Analytical and Safety Testing

The supporting tests that keep a program moving. Mycoplasma screening, endotoxin, sterility by direct inoculation, growth factor testing, and expression confirmation by ELISA, qPCR, or RT-qPCR.

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Why sponsors choose us

Three reasons sponsors stay

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01

Plenty of CROs list clearance on a capability page. It is the majority of what we do, every week, across monoclonal antibodies, recombinant proteins, gene therapy, cell therapy, vaccines, and plasma products. That volume is why our scientists have usually seen your process step before.

02

Some sponsors want to hand over the whole scaled-down process. Some want to stand at the bench with us. Some only want us handling the spiking and titrations. We support all three, and we will tell you which one actually fits your stage instead of selling you the largest one.

03

The 2024 revision opened the door to prior knowledge and modular clearance strategies, which can remove studies a sponsor no longer needs to repeat. We design the panel and the study plan around what your filing will actually require, not around what fills the most sample slots.

VIRAL CLEARANCE
POTENCY ASSAYS
VIRUS PRODUCTION
BIOSAFETY TESTING
GLP STUDIES
REGULATORY EVIDENCE
VIRAL CLEARANCE
POTENCY ASSAYS
VIRUS PRODUCTION
BIOSAFETY TESTING
GLP STUDIES
REGULATORY EVIDENCE
Viral clearance, in detail

Clearance studies, designed for the filing they end up in

A clearance study is not one study.

It is a panel decision, a set of worst case conditions, and a stack of preliminary work that determines whether the real study is worth running.

We start with toxicity, interference, and hold control testing so you find the problems in a cheap experiment rather than an expensive one.
Then we evaluate your inactivation, chromatography, and filtration steps against a panel chosen for genome type, capsid structure, physicochemical resistance, and size.
If your process is not locked, we will say so and run a non-GLP or for information only study instead. It costs less and it tells you what you actually need to know at that stage.
GLP
Non-GLP
BSL-2
Talk through your process
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Sample preparation for a viral clearance study
In the lab
Why this work matters

Every therapy in our labs is somebody’s last good option. Between that therapy and that person is a set of questions about safety that has to be answered with evidence, not intent.

Answering those questions is the whole job. We do it carefully, we do it on the schedule we committed to, and we tell you what the data says even when it is not what you hoped for.

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Facilities

Where the work happens

BSL-2 and BSL-3 containment, a virus library built over three decades, and standard HPLC capability on site. Our North America operation is expanding into a new purpose-built facility.

Request a facility overview →

Tell us what you are trying to clear.

Send us your process, your stage, and your target filing date. We will tell you what studies you need, what you can skip, and what it will take to get there.

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