The large size of pDNA can present a challenge for sterile filtration unit operations, as the product can be retained by the filters, leading to yield loss and low filtration capacity. Additionally, large pDNA molecules can be shear sensitive and use of a sterile filtration step has the potential to cause shear-induced denaturization of the product. Viscosity must also be considered as flow rates for sterile filtration steps can be low due to viscous material. Finally, a sterile filter must be proven to retain bacteria, which can be problematic for pDNA vaccines containing adjuvants.
Optimization of a sterilized grade filtration unit can help increase yield and filtration capacity. Read on to learn more!