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Sensitivity of a PER . C6 ® cell line to bis (2,4‐di‐ tert ‐butylphenyl)phosphate and evaluation of a new, biocompatible single‐use film
Author(s) -
Jachuck Joshua R.,
Krishnathu Soumya Mohanan,
Landau Jeffrey E.,
Ko HsuFeng,
Bhatia Ravi
Publication year - 2020
Publication title -
biotechnology progress
Language(s) - English
Resource type - Journals
SCImago Journal Rank - 0.572
H-Index - 129
eISSN - 1520-6033
pISSN - 8756-7938
DOI - 10.1002/btpr.3060
Subject(s) - chinese hamster ovary cell , cell culture , bioprocess , cell growth , cell , chemistry , biocompatibility , nanotechnology , biochemistry , materials science , biology , chemical engineering , engineering , organic chemistry , genetics
Abstract Single‐use technologies have brought numerous advantages to the biopharmaceutical industry. In particular, single‐use bags made from multi‐layered polymeric films have been adopted for cell culture and liquid handling operations in place of traditional stainless‐steel systems. Despite the advantages, leachable compounds originating from the film's materials of construction present a new challenge. In 2013, bis (2,4‐di‐ tert ‐butylphenyl)phosphate (bDtBPP) was identified as a common leachable from several single‐use bags that is detrimental to the growth and viability of many Chinese hamster ovary (CHO) cell lines. While much work has been completed to characterize CHO cell sensitivity to bDtBPP, little has been done to characterize its impact on other important production cell lines, particularly PER.C6®. This publication investigates inconsistent cell growth observed in a PER.C6® cell line during bioprocess development. The growth inhibition was linked to leachable migration from Bioclear™ 10, a single‐use film from Cytiva (formerly GE Healthcare) that was used for cell expansion. It was shown that the PER.C6® cells displayed a sensitivity to bDtBPP, comparable to that observed in sensitive CHO cell lines. Finally, biocompatibility of PER.C6® with Cytiva's new Fortem film was evaluated, demonstrating that Fortem™ film is a suitable single‐use technology for culturing PER.C6® cells.