Analytical development for gene therapy and recombinant vaccines
Our experience with a wide variety of biological products, from assay development through validation, across different global sites, has equipped us to handle unique and challenging program requirements.
Our team is very experienced in developing, qualifying and validating a variety of analytical methods for in-process monitoring and release testing consistent with current FDA/EMA guidelines.
Our assay teams can provide you with a wide variety of analytical tools that your program requires for critical in-process testing and to monitor unit operation and process recovery.
FUJIFILM Diosynth Biotechnologies’ Analytical Assay Capabilities
- Cell based assays – TCID50, plaque assays, potency assays
- PCR/qPCR/ddPCR
- ELISA
- BCA/Silverstain/Western blots/ CE-SDS
- Aggregation
- HPLC
- Host Cell Protein and DNA
- Nanosight
- DLS
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Process development for successful gene therapies
Process development for successful gene therapies
Analytical development for gene therapy and viral vaccines
Analytical development for gene therapy and viral vaccines
Gene therapy and viral products cGMP production
Gene therapy and viral products cGMP production