Single-Use Upstream Processing: Ultimus® Film Delivers Comparable Cell Growth Performance To Glass

By Kimberly Mann, Marisa Maher, Diana Perez, Patricia Kumpey, Derek Silva, and Alison Dupont

In the biomanufacturing workflow, single-use technologies are increasingly being incorporated to achieve greater efficiency and productivity, reduce capital investment in facilities and equipment, and minimize the risk of cross-contamination. Despite their many benefits, single-use technologies pose some risks.

Irgafos^® 168 (tris (2,4-di-tert-butylphenyl) phosphite), commonly used in single-use films, produces the by-product bis (2,4-di-tert-butylphenyl) phosphate (bDtBPP) following exposure to gamma irradiation. Even at low concentrations, bDtBPP inhibits growth of Chinese Hamster Ovary (CHO) cells commonly used for mAb and recombinant protein cell culture processes.

Here, we explore the findings of studies analyzing the performance of upstream bioprocessing with Ultimus^® film, a single-use, multi-layer film with a fluid contact layer free of Irgafos^® 168. The results confirm cell growth, protein production, and protein quality were equivalent in cultures using media stored in single-use bags made with Ultimus^® film and the more traditional glass bottles.