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Read more: test

The creation of a regulatory-compliant cell bank is an essential component in the production of well characterised biopharmaceutical products. The use of qualified cell banks provides opportunity to detect and identify (and thereby exclude) possible contaminating adventitious agents such as viruses and mycoplasma prior to their use in manufacture. By establishing a cell bank, the manufacturer can ensure that a uniform population of cells is preserved, and then used as start material for each manufacturing campaign.

Also of importance is ensuring that the integrity of the cell bank is maintained and that a sufficient supply of material is readily available for the life of the product. ViruSure is dedicated to meeting your manufacturing needs for the production of cell banks for recombinant biopharmaceutical and for vaccine production. Our significant technical and regulatory expertise provides you with the project management and support you need for efficient product development and with guidance you can trust to ensure regulatory approval.

Our cell bank manufacturing services include:

  • Manufacture of the Master and Working Cell
  • Banks to GMP standards
  • GMP storage of Master and Working cell banks in either ultra-low freezers or liquid nitrogen (for more information, click here)

If you have a specialized product, perhaps produced in an unusual cell line or which is introducing a technology not previously the subject of intensive study in humans, then the panel of tests may need to be custom developed in order to ensure that all potential risks are adequately addressed. The experience available within ViruSure covers a wide range of test development including:

  • Quantitative real-time PCR assays
  • Retrovirus assays
  • Cell culture based assays
  • In vivo tests
  • Immunological assays

Developing the best test strategy for products which presents new concepts or new technologies to regulatory authorities can be a challenge. It requires an in depth knowledge of the system worked with, the potential risks that might exist, as well as the issues most likely to receive intense scrutiny by the regulatory agencies. At ViruSure, we will work with you to identify a sound and cost effective strategy, if necessary assist you with discussions about your product with the regulatory agencies. Ensuring that your pathogen safety testing strategy has the highest chance of success- is one of our prime objectives.

Some examples of products likely to require custom designed assays or pathogen safety strategies are detailed below:

  • Gene therapy vectors (e.g. tests for replication competent viruses)
  • Animal derived products
  • Vaccines (live vaccines can often present a challenge for pathogen safety tests due to the presence of live virus)
  • New technologies or systems not previously tested in humans or animals
  • Cell based therapies

This page is currently under construction. We thank you for your understanding.

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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.

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