Limit of in vitro cell age (LIVCA)
This workstream is developing a risk-based, best practice approach for the design and execution of limit of in vitro cell age studies (LIVCA).
LIVCA studies are complex and regulatory guidance is unclear, lacking, or often disregarded by regulators
Strategies for obtaining and testing the end-of-production cell age can vary significantly. The resulting lack of harmonization in approach drives significant variation in requirements within an organization and across the industry. As the LIVCA specification is required for the BLA filing, these differences can impact scheduling and long-term manufacturing of a product.
Create a set of simplified and standardized approaches to conducting LIVCA studies
Using industry feedback, the team is evaluating the best ways to execute the range of LIVCA strategies, highlighting pros and cons, including:
- Recommendations for which aspects of LIVCA studies could and should be conducted at a smaller than commercial scale and justifications for these
- Key messages for regulators to support justifications
- Exploring new process technologies and testing strategies
- Selection of expression system, which dictates genotypic testing
Limit of in vitro cell age (LIVCA) 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.
To find out more about how BioPhorum can help your business, enter your details below and a member of our team will be in touch.