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Pillars of Safety

Pillars of Safety have, for many years now underpinned the strategy for ensuring the pathogen safety of biopharmaceutical products. Whilst the contribution of each component of Pillars of Safety to overall product safety is different for each product , a successful pathogen safety strategy includes all components.

Sourcing

Sourcing strategies can play an important part in ensuring that the start materials used for production do not inadvertently introduce adventitious agents into the product. Products of animal origin represent a particular challenge to ensure that appropriate controls are established to limit the introduction of viral and/or prion agents.

Testing

A robust testing strategy must be developed which provides assurances with regards to the absence of viruses and/or prions from the start material used for production. Although there is a panel of standard tests that can be applied (i.e. in vitro & in vivo tests for adventitious agents, tests for retroviruses), additional tests may be necessary depending on the nature of the product. ViruSure will be happy to provide advice and work with you to develop a testing strategy best suited for your product.

Virus or Prion Clearance

The removal of potential infectious agents via the manufacturing process can provide a high level of assurance for those products subjected to purification prior to formulation. The design of the manufacturing process is therefore important to ensure that adequate clearance will be provided for a range of viruses (including those most likely to be of concern for the product in question). The poor design of virus clearance studies inevitably and frequently leads to additional questions and delays in product marketing or entry into clinical trials, and therefore care should be taken in ensuring that your studies will meet the now exacting requirements for virus or prion removal studies.

For products not subjected to purification (e.g. some vaccines), the emphasis for providing adequate assurance with regards to viruses and prions falls strongly on the two other strategies detailed above.

ViruSure can guide you and provide expertise in this area.

Virusure GmbH

Donau-City-Stra├če 1, A-1220 Vienna, Austria.
Phone: +43-(0)1-2699120
Fax: +43-(0)1-2699120/22

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