Vaccine products must meet stringent regulatory requirements. Amongst them, purity is sometimes the hardest to deliver. For products using Bovine Serum Albumin (BSA), the purification of this contaminant can require complex unit operations that are both costly and hard to scale up.
A company using the MRC5 cells grown in a fetal bovine serum to develop a vaccine needed a practical solution to keep bovine serum albumin (BSA) levels < 30 ng per dose to comply with WHO requirements.
The UniFuge® Pilot was used for cell harvesting, concentrating and washing the cell slurry prior to discharge. Single-use modules have the potential to eliminate complex and expensive downstream purification steps. Also, the UniFuge is a closed system that minimizes the risks of contamination and is fully scalable.
Using the UniFuge allowed the team to maintain a closed system and to achieve the desired results within the required BSA limits, enabling safe vaccine production at scale. When using the single-use modules, studies have shown that 4 to 5 bowl volumes of buffer (8 to 10 liters) resulted in a wash efficiency of 99%.