Viral clearance
From feasibility to definitive studies. Scale-down models and virus panels built around your process.
Viral clearance & viral safety specialists
Clarity in
every step
of science.
Your lab, amplified. Deep scientific expertise. Direct access to the people behind your study.
Formerly Texcell North America
SCIENCE / EXPERTISE / TRUST
Built for confidence
GLP · 21 CFR Part 58
2+viruses per run
2
GLP laboratories
Frederick & Shanghai
10,000+
Viral clearance studies
Texcell group since 1990
3
Ways to work together
From sponsor-run to full transfer
1
Accountable Study Director
Direct scientific access
Built for review underICH Q5A(R2)ICH Q5D21 CFR Part 58 · GLPFDA · EMA review
Scientific capabilities
Depth where the
risk is highest.
Every study is scoped to the question your program needs answered—and the questions a reviewer is likely to raise next.
Custom cell culture
Cell banking, expansion and cryopreservation. Scientific support from your program’s earliest stages.
Viral safety
Adventitious agents, mycoplasma and cell bank testing. Surface risk before it reaches your critical path.
Viral clearance
Scoped to the guidance your submission will be reviewed against, with scale-down models that hold up to scrutiny.
- GLP, investigational and FIO formats
- Low pH, chromatography and virus filtration steps
- Reported as log reduction per step
Your science.
Our shared responsibility.
The Cytaclar approach
Not just a study.
A scientific partnership.
You work directly with the scientist running your program. We challenge assumptions early, define feasibility first and build a study that stands up to review.
A named, accountable Study Director
Feasibility before the protocol is locked
Independent quality assurance
- 01
Choose the panel
Risk-based model and relevant virus panel, selected by source species, material and process.
- 02
Test the matrix
Matrix-specific cytotoxicity, interference and spike-recovery assessment.
- 03
Define worst case
Scale-down model review and worst-case parameter definition.
- 04
Run the definitive study
Cell-based infectivity quantitation (TCID50), with qPCR supporting removal steps where appropriate.
Multi-spike technology
More insight.
Fewer runs.
Multiple model viruses in one process load. Each quantified independently. A smarter approach to the same scientific question.
2+
Viruses in a single run
20%+
Less technical time*
*Depending on study scope. Published in Biotechnology and Bioengineering, 2025. DOI: 10.1002/bit.70085.
Independent quantitationOne load. Multiple viruses.
Animal-derived materials
Different materials.
The same rigor.
Viral safety programs built around your material, not a standard liquid-load assumption. From collagen and gelatin to tissue matrices, serum and plasma.
Collagen & gelatin
Tissues & matrices
Serum & plasma
Other raw materials
Quality & accountability
Confidence isn’t claimed.
It’s documented.
A study is only as strong as the data behind it. Every result traces to its observation, every deviation is recorded and every responsibility is clear.
01
One accountable Study Director
A named Study Director holds overall responsibility, is on your protocol, and answers your questions directly.
02
Independent quality assurance
A separate QA unit inspects critical phases and signs the statement accompanying the final report.
03
Protocol first, deviations on record
Protocols are approved before work begins. Deviations are documented as they happen.
04
Raw data that rebuilds the study
Contemporaneous, attributable records in a controlled archive — every result traces to its observation.
Work your way
Your process.
Your level of involvement.
The virus work is ours at every level. Choose the collaboration model that fits your team, resources and program.
IService level
You run your process, in our laboratory
Your team executes the scaled-down process on site. We spike, provide the virus panel and titrate.
IIService level
We run it alongside you
Our staff assist your team in executing the scaled-down process at our laboratory.
IIIService level
Tech transfer, and we execute
The process is transferred to us and our personnel run the entire study. No travel, no bench time from your team.
Connected expertise
Local partnership.
Global perspective.
A new name on decades of scientific experience. The people, the sites and the science behind your program remain.
Frederick
01Maryland, USA
GLP viral clearance, viral safety, cell culture and bioassays.
Shanghai
02China
GLP viral clearance and GMP viral safety testing.
Japan
03Client coordination
Local program coordination with testing in Frederick or Shanghai.
A fast, non-GLP study run before the process is locked. It shows what log reduction a step can achieve, while there is still time to optimize.
Let’s talk science
The next step starts
with a conversation.
Tell us what your program needs to prove. Let’s design the path forward, together.
info@cytaclar.com4998 International Boulevard
Frederick, Maryland 21703