Making and Moving Operational Cell Banks
This workstream is establishing consistency in the technical requirements for replenishing working cell banks by using a science and risk-based approach to shape regulatory expectations.
Regulatory requirements for introducing replenishment working cell banks (WCBs) in many countries are highly variable
Having proposed a risk-based approach to provide consistent cross-industry expectations for WCB qualification strategy, the team has transitioned into a community of practice to monitor practical implementation experience of the guidance and its interpretation by regulators.
Increasing Health Authority requests for additional stability testing
Incorporating stability monitoring for all storage sites, including those established to mitigate business continuity risks, results in quicker depletion of cell banks. This workstream is developing a position statement outlining the scientific rationale for current industry practice not to include these sites in the stability monitoring program.
Making and Moving Operational Cell Banks deliverables
More related workstreams
Our workstreams focus on the areas with the greatest impact across the industry. Led by science, our members are problem-solving today’s sustainability issues. By working with the regulatory governance community, they are also creating future-ready outcomes for the industry.
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