Analytical Development
At FUJIFILM Diosynth Biotechnologies we utilize analytics for efficient, quality driven and phase-appropriate development of programs. Our analytical teams specialize in the development of assays to support scale-up, effective process monitoring and cGMP production.
Core services include:
- Method Transfer
- Method Development
- Method Qualification
- Method Validation
At FUJIFILM Diosynth Biotechnologies our analytical development activities are driven by:
- Innovating
- Building quality into the product, maximizing the design space and minimizing risk in method performance
- Maintaining a line of sight to manufacture
- Reducing development costs and timelines
- Utilizing high-through-put robotic resources and leading edge technologies to future proof your analytical portfolio
- Generating the appropriate data to support the regulatory transition into commercialization
General Analytical Capabilities:
- H/UPLC with a variety of detection modalities
- SDS-PAGE and Western blotting
- CE-SDS and cIEF
- Protein content
- UV spectroscopy
- Bioassays and Immunoassays
- Mass Spectrometry
- Product Characterization
- Process Residuals
- Biophysical Characterization
- Compendial methods
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