The innovative downstream facilities at uBriGene improve time and cost efficiency of the purification process. Experts with extensive production experience from our downstream team can optimize production techniques to improve time and cost efficiency while ensuring safety and quality. Our own innovative two-step chromatography purification achieves the same quality standard as a three-step process, but is quicker and reduces cost up to 85%.
uBriGene’s viral products are processed in Grade C + Grade A cleanrooms (Cleanroom Classifications according to EU GMP standard). Cell culture and purification are carried out in Grade C cleanrooms, and aseptic filling is carried out in a Grade A aseptic isolator. In addition, each workshop has independent ventilation and air conditioning systems to minimize the possibility of contamination and cross-contamination.
We have experience developing 10+ types of plasmids and manufacturing more than 30 batches (200mg-20g) in total. Our continuous alkaline lysis technique with full parameter control is highly efficient and can be scaled up linearly. The yield of downstream purification is about 30-50%, around 1000 mg/7L fermentation volume. In a recent case, a 140L fermentation volume produced 66g of plasmids and yielded approximately 20g of plasmids after purification.
We have a well-developed purification platform for multiple serotypes including rAAV2/2, rAAV2/5, rAAV2/8, and rAAV2/9. A two-step chromatography process is used for purification instead of ultracentrifugation, so iodixanol is not needed.
Clients can choose between ultrafiltration purification, which is suitable for low viral demand, or column purification, which is suitable for large-scale production. Our yield of lentivirus is about 5 to 10 times of CF10 per liter of supernatant.