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Define Goals
Describe what you want to achieve from the development work. Consider purity, quantity, safety, economy and your deadlines.
- Consider the desired scale as well as the final purity of your target molecule. Some methods are simply not scalable and need to be excluded as soon as possible.
- Define acceptance criteria for identity, homogeneity, purity and potency of your target molecule. Do not only focus on purifying the target molecule but also on removing impurities. Identify critical impurities and contaminants. Do not forget nucleic acids, endotoxins, proteinases and viruses as well as product variants, aggregates, deglycosylated molecules, etc. where relevant.
- Set a realistic ambition level for the timing of your project. Set deadlines and key milestones. Do you have sufficient resources and time to achieve this?
- Set acceptance criteria for the robustness of the process. Consider overall risks regarding stability, safety, possible contaminants, leachables, pathogens, endotoxins, etc. Variability in feed material always occurs and the process must be designed to handle the expected degree of variation.
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