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.
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
- Blood products
In the viral inactivation steps:
- pH treatment
- Chemical treatment (Betapropiolactone, H2O2)
In the viral elimination steps:
- Chromatography (protein A, ion exchange)
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.
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.
|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|
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.