Testing

Manufacturers of biopharmaceutical products, such as blood products, monoclonal antibodies, recombinant proteins, and medical devices are required to demonstrate their process capability to remove or inactivate viruses. Viral contamination often arises from the source of cell lines, tissues, or use of animal derived raw materials. The ICH Q5A regulatory guideline suggests that manufacturers of biopharmaceutical products for human use should ensure the safety aspect of their products free from potential contaminants. One way of assessing viral safety of biopharmaceutical products is to perform a viral clearance study on the manufacturing process.

Viral clearance is performed to assess the capability of purification process to remove and/or inactivate potential viral contaminates likely to be present in or introduced during the production of biopharmaceutical products. Regulatory requirement of viral clearance varies between regulatory agencies.

In general, a duplicate study of 2 viruses, including a robust virus, is required to demonstrate the capability of virus removal / inactivation. The selection of model and specific virus is depending on source evaluation of the study material and characteristics of virus. The selected virus is spiking into a down-scaled version of purification steps with a known virus titer. By determining the log reduction factor of virus titer, the ability of a purification step to inactivate or remove virus can then be quantified.

Infectivity assay is the most common and preferred approach to determine the effectiveness of a process step in removing and/or inactivating viral contaminates. Incorporating with real time quantitative PCR into a viral clearance study allows the viral genomic copy number to be determined thereby distinguishing between virus removal and inactivation.

TFBS take a customized approach, including advisory and regulatory support in the selection of process steps and model virus, and subsequent design of the study protocols, to ensure a successful program to be established and performed based upon clients’ timelines. Customized study is also available in response to variety of biopharmaceutical products and medical devices.