Hydrolysates (peptones) are widely used in biopharmaceutical manufacturing to enhance cellular growth and production. Ultrafiltration is often utilized to remove large molecular weight entities including endotoxin from hydrolysates. While minimization of endotoxin is a high priority in biomanufacturing, the necessity of ultrafiltration of raw materials has not been firmly established.
Some data suggests that ultrafiltration negatively impacts hydrolysate performance in cell culture media by removing small molecular weight entities that act as growth factors in the media. Moreover, the necessity of hydrolysate ultrafiltration in cases where the material is already low in endotoxin is unclear, despite unsubstantiated claims in the industry that ultrafiltered material supports superior cell culture performance.
LucraTone™ hydrolysates are manufactured by Solabia for exclusive distribution by Millipore. Evaluation of multiple hydrolysate lots indicates that manufacture of LucraTone Soy hydrolysates yields consistently low endotoxin levels, as well as low levels of large molecular weight entities, despite the lack of ultrafiltration in the manufacturing process.
The lack of ultrafiltration of this product provided an opportunity to evaluate the impact of ultrafiltration of hydrolysates on mammalian cell culture performance. In this case study, multiple lots of both ultrafiltered and nonultrafiltered LucraTone Soy P hydrolysates were evaluated to determine their impact on mammalian cell culture performance. Results of our study suggest that there is no impact of hydrolysate ultrafiltration on cell culture performance.