Virus Clearance Studies

To ensure the safety of biopharmaceutical and biological products

ViruSure has been involved in the design and execution of virus clearance studies for over 15 years. With our extensive experience of over 600 successful studies we are the experts in virus clearance studies.

Investigations of the ability of a biopharmaceutical product’s manufacturing process to remove or inactivate viral agents can provide assurance of the virus safety of the product, as detailed in international guidelines. Such studies are essential prior to any clinical trials. ViruSure offers GLP as well as non-GLP virus clearance studies including consultancy on the best study design. We base the study design on the vast expertise of our scientists acquired over decades performing virus clearance studies.

We have performed the virus clearance studies across a wide range of biopharmaceutical products. Whether your product is early stage or in late-phase clinical trial, we ensure the best study design to meet regulatory requirements.

At the process level, the study design must also include orthogonal process steps. These are defined as process steps with different mechanisms of virus inactivation or removal.

Selection of the virus panel is a critical element of your virus clearance study and is dependent on the risk profile of the product. The selection should cover a range of viruses with different physicochemical properties, including those with high resistance to inactivation, and viruses which are potential contaminants.

What our Clients Say

Simon B. , Principal Scientist, Downstream Process Development

We have worked several years with Virusure conducting Viral Clearance studies, where the team during planning contribute at a high scientific level. The execution of the study is well organized – sometimes like they are reading our minds.

Virus Selection for Clearance Studies

The viruses highlighted in blue below are almost universally selected for recombinant biopharmaceutical products. Other virus types will be selected for other modalities such as blood- and animal-derived products. The table is a small selection of all available model viruses at ViruSure.

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Target Viruses
Example Model Viruses
Genome
Size (nm)
Envelope?
Resistance
Retroviruses
Murine leukaemia virus
2X ssRNA
80-110
Yes
Low
Pestiviruses
Bovine viral diarrhoea virus
ssRNA
50-70
Yes
Low
Paramyxoviruses
Bovine parainfluenza virus 3
ssRNA
100-200+
Yes
Low
Herpesviruses
Pseudorabies virus
Bovine Herpesvirus
dsRNA
120-200
Yes
Low-Med
Coronaviruses
Transmissible gastroenteritis virus
ssRNA
120-160
Yes
Low
Reoviruses
Reovirus type 3
dsRNA
60-80
No
Med-High
Polyomaviruses
Simian virus type 40
dsRNA
40-50
No
High
Parvoviruses
Mice minute virus
Porcine Parvovirus
ssDNA
18-22
No
High

Please contact us for a tailored virus selection for your studies.

600+ successful virus clearance studies performed to date across a wide range of therapeutic modalities and products. Download our fact sheet below to learn more.

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