GMP TEM
Viral Particle
Characterization

For Cell Line Characterization & Bulk Harvest Analysis
Provided to you with our Partner

State-of-the-Art Digital Transmission Electron
Microscopy (TEM)

  • GMP quality analytical test methods to characterize and quantify the retroviral burden in Cell Line & Bulk Harvest samples
  • Generically validated test methods (according to ICH Q2 guidelines)
  • Leading Turnaround Times
  • Digital data handling and audit trails in accordance with 21 CRF Part 11 regulations
  • State-of-the-art Laboratory, TEM & CSV systems

Strong collaboration with Charles River Laboratories for GMP TEM Viral Particle Characterization

Together with our Partner Charles River Laboratories, ATEM offers highly standardized and generically ICH Q2 (R2) validated Analytical Test Methods for the detection and quantification of virus-like particles in whole Cells and Bulk Harvest matrices.

Currently, ATEM offers the following generically validated Analytical Test Methods:​

Evaluation of 200 Cell profiles to characterize the (retro-) viral burden

Evaluation of Bulk Harvest material to quantify retroviral burden 

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ATEM & Charles River Laboratories combining leading GMP expertise with fully digital & state of the art TEM processes

ATEM operates a fully GMP certified Transmission Electron Microscopy (TEM) testing facility in Germany and is registered with and audited by the competent authorities. Our state-of-the-art digital facility and highly trained teams enable us to deliver excellent results to our customers faster, while meeting the regulatory demands for quality of results, digital data handling and audit trail of today and the future.

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