Clean Cells Fast-Track Testing Services

Rapid, flexible QC testing for every assay type without compromising on GMP quality.

In biologics development, every day counts. Clean Cells Fast-Release Testing Services combine alternative rapid methods with compendial assays to deliver GMP-validated results in days rather than weeks. From sterility and mycoplasma to identity, and RCL, our integrated panel is optimized for tight timelines, so you can keep your project on track. 

Key assays and turnaround times

Assay  Clean Cells method  TAT  Traditional method TAT 
Liberation Sterility  Automated BactAlert™  7 days  Culture-based  

14 days 
Mycoplasma  BioFire® Mycoplasma and qPCR  3 days  Culture & indicator cell assay  

28 days 
Characterization  Host-Cell DNA  qPCR fast-track format 2 weeks  qPCR (regular format)  

4 weeks 
NGS viral safety  Transcriptomic approach  6 to 8 weeks  In vivo method  

at least 10 weeks
NGS Identity  Targeted Illumina® NGS panel  3 to 4 weeks  Sanger 

4 to 6 weeks 
Gene copy number 

Vector copy number

 Digital PCR / qPCR copy number assay  2 to 3 weeks Southern blot or standard qPCR  

4 weeks 
Production Single cell seeding  

(cell dependent) 

 Automated single-cell isolation & expansion  3 to 4 weeks  Limiting dilution & manual expansion  

6 to 8 weeks 
Cell bank  GMP-compliant Master & Working Cell Bank creation  6 to 8  weeks   Competition

 8 to 10 weeks 
Virus seed   GMP viral seed stock production & QC  Lasting from 5 weeks / 

Workflow

  • Kick-off and sample receipt 
  • Priority scheduling in our GMP lab 
  • Parallel processing of rapid and compendial methods 
  • Data review and QC report 
  • GMP Certificate of Analysis (CoA) delivered digitally

 

All assays are performed under our BSL-2/BSL-3 suites and GMP cleanrooms, with full documentation compliant with ICH Q2(R2), FDA, and EMA guidelines. 

Why choose Clean Cells 

  • Speed: Reduce release timelines by up to 80%. 
  • One-stop shop: One lab, one sample, one report. 
  • Regulatory confidence: Assays validated with global compendial and regulatory standards. 
  • Flexibility: From a single test to full panel bundles. 
  • High capacities: 8 GMP-certified testing suites, including BSL-2 and BSL-3 containment, ensuring rapid scheduling with no backlog. 
  • Expert support: Dedicated project manager for each program.

 

Our highly flexible scheduling and rapid sample intake mean we can initiate your QC tests rapidly, giving you the freedom to adapt timelines and keep your project moving.

Fast track retouchée

Contact us to explore our Fast-Release Testing Services!

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