Reveal undesired sub-visible particles in your sample

Control of particles in samples of recombinant proteins and mAbs

Regulatory expectations for the control of particles have increased significantly over the last decade. Orthogonal methods are required to monitor aggregates and particulate matter in the range of 0.1-10um. Factors that can give rise to particles at different process stages are numerous. Below are some examples:

Extrinsic particles arising from the manufacturing process

  • Shear forces from pumps
  • Rubber fragments, e.g. from tubings
  • Leachables from disposable technology
  • Buffer and excipients
  • Silicon oil from syringes

Intrinsic particles due to non-optimized conditions

  • Protein  aggregates

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Particle size distribution of recombinant proteins
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MiniTEM is employed for size distribution analysis of recombinant proteins to detect deviations in size

The size distribution graph shows the number of particles of expected size as well as smaller size debris and aggregates – the data is easily correlated to the content of the acquired images.

 
Aggregate & particle detection
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TEM imaging of different samples of monoclonal antibodies (mAbs)


Single mAbs in a monolayer can be observed as well as stress induced aggregates.

Virus detection in tissue sample
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Retrovirus detection in cell sections with MiniTEM

MiniTEM can be set to automatically search for retroviruses in cell section by using machine learning technology and template matching

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