Engineering Commons^™

Challenges Of Scale Down Model For Disposable Bioreactors: Case Studies On Growth & Product Quality Impacts, Jincai Li, Guangming Zhang, Huilin Zhu

Single-Use Technologies: Bridging Polymer Science to Biotechnology Applications

Despite wide-spread use of disposable bioreactors, there is a lack of well-established scale-down model for larger scale SUBs. Here we report a case of NS0 cell culture process transfer from 2000L stainless steel bioreactor (SST) to 2000L disposable bioreactor (SUB). Initial attempts in trying to grow the NS0 cells in the small scale 2D bags yielded non-satisfactory results, as growth was impacted by bag material type as well as by suppliers of the same bag material type. However, 3D bags of 50L and above proved to be supportive of the NS0 cell line growth.

Even for cell lines that do …

Case Study: Identification, Characterization And Mitigation Of Growth Inhibitory Leachable Compound From Disposable Plastic Vessels, Zara Melkounian

Single-Use Technologies: Bridging Polymer Science to Biotechnology Applications

The inhibition of CHO cell growth was observed in culture medium incubated in disposable plastic vessel, but not in a control glass vessel. Gamma irradiation of vessels during terminal sterilization step was required to produce the growth inhibitory leachable, as unsterilized vessels showed no inhibition of cell growth. Also, the growth inhibition was cell line specific in that some CHO cells were more sensitive than others, and some were not sensitive at all.

Using chromatographic and spectroscopic methods we were able to identify and characterize a single leachable responsible for this growth inhibition in some CHO cells. By understanding the …

Impact Of A Toxic Single-Use Bio-Process Container Film Leachable On Chinese Hamster Ovary Cells, Heather Nunn, Matthew Hammond

Single-Use Technologies: Bridging Polymer Science to Biotechnology Applications

A high-throughput cell-based assay (HT-CBA) was developed to investigate the impacts of the polymer films used to construct single-use bio-processing equipment such as bio-process containers (BPCs) and single-use bioreactors (SUBs) on the growth and health of Chinese hamster ovary (CHO) cells. Cell growth media were incubated in BPCs constructed from several different films, and the media thus treated was used to culture CHO cells in 24 deep-well plates. Multiple films negatively impacted culture growth and viability. The compound bis(2,4-di-tert-butylphenyl)phosphate (bDtBPP) which leaches at low levels from these films was shown to be highly detrimental to cell growth. The toxic compound …