Role of TCUs in Downstream Processing
- Chromatography SkidsTCUs keep buffers and columns at consistent temperatures to ensure predictable protein binding, elution, and recovery.
Even slight temperature shifts can change protein conformation or resin performance.
- Filtration Systems (UF/DF, Sterile Filtration)Maintain temperature of product and buffer solutions during ultrafiltration/diafiltration to optimize flux and prevent protein aggregation.
Ensure sterile filters operate within validated thermal ranges.
- Centrifuges & Harvest SystemsTCUs provide cooling to reduce shear and prevent product degradation during cell harvest or clarification.
- Formulation & Final Fill PrepMaintain product bulk at controlled temperatures to ensure stability before sterile filtration and filling.
- Storage Tanks & Intermediate Hold VesselsJacketed vessels with TCU loops stabilize bulk drug substance at setpoints (often 2-8C or controlled room temp) between downstream steps.
- Cold Chain IntegrationSupport controlled transfer between unit operations and alignment with cold rooms or blast freezers.
