Fujifilm Diosynth Biotechnologies specializes in development of analytical assays and their qualification to support production and examine expression of our clients` therapeutics and virus vectors. We continually evaluate how best to utilize analytics for efficient, cost effective product quality driven and phase appropriate development and execution of programs. Our Virus Analytical Development team is very experienced with the analytical development strategies needed from Monitoring Production to Final Release potency and Impurity Testing.
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