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Get Involved: ISPE Virology Special Interest Group

Anne Stokes, PhD
Get Involved: ISPE Virology Special Interest Group

The current COVID-19 pandemic has heightened the awareness and attention to virus safety and risk mitigation for manufacturers. Each manufacturer has a strategy in place to mitigate the risk, however by manufacturers working together, this can lead to synergies and best practices in the way that the risk is managed. Also, additional guidance is required by the Industry in a field that is constantly evolving and introducing more ways of manufacturing biopharmaceuticals including continuous manufacturing, single-use manufacturing equipment in line with Regulatory Guidance updates and appropriate virus safety measures need to be in place.

In response to this new awareness, ISPE has created the Virology Special Interest Group (SIG) to share knowledge and best practice within the Biopharmaceutical manufacturing Industry on Virus Safety and risk mitigation. This SIG may be of interest to members of the Containment, Disposables, Sterile Products Processing, Critical Utilities and HVAC Communities or to any ISPE member interested in learning more about this topic. Whilst the risk of virus contamination of a Biopharmaceutical Manufacturing plant is low, the impact is very high, leading to significant efforts and funds required to clean down the facility and mitigate the risk of a return of the virus in addition to a risk to the continued supply of materials to the patient.

Curious of the scope of the Virology Special Interest Group (SIG) and what key interest areas will be covered? The SIG will be working will delve into the areas of:

  • Virus Safety and risk management in GMP Manufacturing facilities according to ICHQ5A
    • The ICHQ5A is currently undergoing a revision to revision 2 so the time is right to be discussing the virus safety aspects of this guideline including testing and sourcing of raw materials, testing of cell banks and in process samples and virus clearance validation.
  • Virus Safety strategy for Continuous Manufacturing processes
    • The introduction of Continuous Manufacturing is at an early stage. Industry is discussing how to apply ICH Q5A requirements to ensure a virologically safe product stream.
  • Virus Safety Testing including new methods of detection and their application
    • Over the past decades since ICH Q5A was published, novel technologies for virus detection have been developed. There is much discussion on the introduction of these technologies and how and when to implement them and whether they are fit for purpose or prime time.
  • Sourcing of raw materials and removal of animal derived raw materials from manufacturing processes and appropriate raw material risk assessments.
    • Over the years Companies have worked hard to remove animal derived raw materials from their manufacturing processes and substitute them for chemically derived materials with much success and this has led to a reduction in virus risk. However, the control framework around raw and starting materials including the history of the cell line and what it has been exposed to is important in developing a control strategy.
  • How to react in the light of a pandemic (e.g. COVID-19) and Industry response to emerging viruses.
    • The Covid-19 pandemic in 2020 took the Industry by surprise, challenging their control framework and crisis continuity plans and creating a crisis in terms of raising questions as to whether it presented and extra challenge to the measures that were already in place. Questions raised were: a) are the indicator cell lines sensitive to detect the virus b) Do the facility disinfectants inactivate the virus c) Does the low pH step mitigate virus risk if it is present d) are there any further measures required for Operators in the manufacturing plant and e) will there be an interruption to the supply chain for raw materials and consumables.
  • Facility control including engineering design, pest control, disinfectant use and cleaning, single use components and risk of cross contamination.
    • Virus control requires holistic measures in a manufacturing facility to manage risk according to ICH Q7 as well as the measured described in ICH Q5A.

The initial intent is to publish a Guideline that reflects the current thinking regarding virus safety risk and mitigation for raw materials supply to the Biopharm Industry. Further topics will also be covered by the SIG and we request any input or comments on the scope and future path forward for this team.

Update my Communities

Led by Anne Stokes, Chair, the Virology Special Interest Group (SIG) welcomes members to join the conversation on this new ISPE Community. We are also seeking experienced SMEs interested in working on projects in the key interest areas included in our scope. For more information, contact Barbara Peck.

Virology Resources

Risk Based Approach to Mitigate SARS – COV-2 Challenge to the Virus Control Framework in Industrial GMP Manufacturing Facilities Webinar

Risk Based Approach to mitigate SARS – COV -2 challenge to the Virus Control framework in Industrial GMP manufacturing facilities

Presented on June 11, 2020 - Panel discussion will focus on the SARS-CoV-2 situation and factors to be assessed in a GMP Biopharmaceutical manufacturing facility.

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