Analytical Development of biologics and advanced therapies is being driven by a new era of analytics and regulations. At FUJIFILM Diosynth Biotechnologies we are continually evaluating how best to utilize analytics for efficient, cost effective product quality driven and phase appropriate development of programs.
Our Analytical Development Philosophy
Our Analytical Development philosophy has its core one main objective: developing and utilizing methods that have built- in success strategies for your Program.
Analytical Capabilities for Gene Therapy and Viral Vaccines
Having the ability to measure the amount of infection in a viral product expressed through a Host/Virus system is essential for long term success. Some of the analytical challenges include determining what is the ration of infections versus non-infections viral particles. Our Virus Analytical Development team is very experienced with the analytical development strategies needed for viral products.
Viral Product Characterization capabilities include:
- Virus Strain Identity
- Infectious titer measures
- Viral particle population dynamics, cell substrate characterization