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Charting New Paths for Advanced Therapy Testing
The lack of standardized test methods underscores the importance of establishing a creative and customer-centric approach for new modalities
Despite a slow start to the year, an upward trend in biologics testing is beginning to reappear.
“While we still see a lot of new antibodies going into the pipeline, I think in terms of growth probably viral vectors is the area where we are seeing a huge increase in demand.”
Luis Berrade, Charles River’s Senior Director, Global Biologics Testing Sales
However, these new modalities involve extensive testing due to the lack of established, validated platforms and methods in this space. This means more time must be dedicated to development work, qualification, and validation before these methods can be used to release the product into the market. This is a significant shift from the traditional biologics offerings of recombinant proteins, antibodies, and vaccines.
While established methods for development work related to antibodies exist, there is an undeniable need in the market for a more personalized approach to cell and gene therapies. This field often presents regulatory complexities, resulting in more intensive discussions prior to reaching the Investigational New Drug (IND) stage.
To tackle these hurdles, it is important to foster open dialogues with clients to understand their goals and the technology they're employing which enables the development of methods tailored to their needs. Though the demand for swift development timelines is high, it is critically important to strike a balance with quality assurance and the clients' needs at the forefront, even if it means venturing into uncharted territories.