Our staff has a broad range of technical expertise that can help you through a variety of development challenges.
- Experience in large scale chromatography, cell culture, filtration, and fill / finish.
- Do you need assistance with drafting and submitting a comparability protocol? Post-approval change? IND update?
- Do you need guidance for your process validation? Which of your DOE studies can be used?
- Do you know when to set specifications? When do you have enough data? When to add or remove a test?
- We can help you implement QbD, How to apply ICH Q8-Q9-Q10-- Quality Systems, Design Space
- Should you in-source or out-source?
Process Transfer and Assay Transfer
- When do you transfer your process from clinical to commercial?
- We can assist with internal transfer or to a CMO (Contract Manufacturing Operation).
- Transfer protocols, reports, and data analysis.
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