Viral Clearance Validation for Biopharmaceuticals

The purpose of a Viral Clearance evaluation is to assess the capability of a manufacturing production process to inactivate and/or remove potential viral contaminants. Experience and knowledge in selecting the most relevant target viruses, appropriate purification steps, and viral clearing agents are critical in the design and implementation of a cost-effective and high-quality viral clearance study.

The advent of the biopharmaceutical age has opened new avenues of disease treatment and prevention. However, these biopharmaceutical products, such as monoclonal antibodies, recombinant proteins, vaccines, blood derivatives and animal products carry an inherent risk of transmitting infectious viruses due to the source material used, manufacturing processes, and routes of administration.

Microbac's Microbiotest Division provides the following Viral Clearance services:

* Customized viral clearance evaluation for biopharmaceutical purification processes

* Column re-use and sanitization studies

* Validation of biopharmaceutical cleaning procedure for virus elimination

* Biomedical material cleaning/disinfection studies

* Viral storage stability studies

Please contact Microbac for additional information:

Microbac Laboratories, Inc.
Microbiotest Division

(703) 925-0100

MBT@microbac.com

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