Viral Clearance

Viral Clearance

Clean Cells performs viral clearance studies required by the regulatory authorities for products in early and late development phases (Phase I /II and Phase III of clinical trials): Recombinant proteins, monoclonal antibodies, vaccines and products derived from blood.

Your needs

Viral clearance studies are one of the pillars in the safety of biological products, to be used in humans. These studies demonstrate the ability of a manufacturing process, to remove, or inactivate potential viral contaminants.

Spiking experiments carried out using high titre levels of virus in the steps of the manufacturing process having the greatest potential for the effective elimination, or inactivation of the viral contaminants that are encountered in the products, or process.

Clean Cells performs viral clearance studies for the manufacturing process of these products:

  • Recombinant proteins
  • Monoclonal antibodies
  • Vaccines
  • Blood products

In the viral inactivation steps:

  • pH treatment
  • Chemical treatment (Betapropiolactone, H2O2)
  • Solvent/Detergent
  • Pasteurisation

In the viral elimination steps:

  • Chromatography (protein A, ion exchange)
  • Nanofiltration

Performance of regulatory viral clearance study in phase I/II and Phase III. Two virus models are required for a viral clearance study of a biological product in phase I/II. A more extensive panel of viruses is necessary for a study concerning a product to be used in a clinical trial in phase III.

Our methods

Determination of virus models for the spiking study in function of the products nature, of the process manufacture, and the phase of clinical development.

Selection of the fractions to be tested for the viral clearance study.

Production and characterization of the viral stocks at the highest titre possible.

Performance of preliminary studies (cytotoxicity/interference/spike recovery/quench analysis).

Performance of a main study which will consist of the evaluation of the ability of the process step to inactivate or eliminate the model virus chosen.

Determination of the log reduction factor of the virus for each step and interpretation of the results.

Our solutions

Family Model Genome Size (nm) Envelope Resistance
Parvoviridae MVM, PPV ssDNA 18 – 26 no very high
Adenovirudae HAdV5 dsDNA 70 – 90 no int. -high
Picornaviridae HAV, EMCV ssRNA 25 – 30 no int. -high
Reoviridae Reo3 dsRNA 60 – 80 no intermediary
Herpesviridae PRV dsDNA 120 – 200 yes weak – int.
Flaviviridae BVDV ssRNA 40 – 60 yes weak – int.
Paramyxoviridae BPI-3, HPI-3 ssRNA 150 – 300 yes weak
Retroviridae HIV-1, MuLV, ALV-B ssRNA 80 – 100 yes weak

 

Our differences

Quality

Viral clearance studies are carried out in GLP grade.
The titration tests are in the format TCID50 and validated according the guidelines ICH Q2 (R1).
Titration Tests by qPCR are available and validated according the guidelines ICH Q2 (R1).
Study Protocol specific for each client.

Laboratory and Equipments

Laboratory and equipment specially dedicated and confined BSL2 and BSL3.
ÄKTA purifier is available on-site.
The ability to carry out studies at 4-8 ° C and at room temperature.

Communication and Management of study

Direct contact with the study director, responsible of your project, and fully dedicated to the viral clearance service.

Catalogue Test

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