Oligonucleotides
Confidential Client, Oligonucleotide Development Pilot Plant
Mainland Europe (EU)
DPS was engaged to develop a feasibility study to locate an oligonucleotide development and scale up facility at an existing site within the client network.
About this project
The study involved assessment of multiple locations to conclude with the preferred location. The facility would support 2 Oligo NMEs per year at an 80mmol/batch scale. The project considered, non-cGMP, cGMP ready and fully cGMP operational options.
Process/support systems
The study considered a facility design to accommodate the typical process unit operations;
- Synthesis and Cleavage/Deprotection
- Chromatography and Ultrafiltration
- Annealing
- Lyophilisation
A SuperPro, SchedulePro model was created to assess operational strategies and mass balances.
Support activities included amidite, buffer and solvent weigh and dispense, buffer and solvent preparation, column packing, equipment wash and preparation, raw material storage, cold room and final product freeze storage.
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