Interlaboratory Test for Detection of Cytotoxic Leachables arising from Single‐Use Bags

Steiger, Nina; Eibl, Regine

doi:10.1002/cite.201390026

Cited by 2 publications

(1 citation statement)

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“…Leachables are most dreaded for single-use systems, because they occur under real process conditions and, in the worst case, can be toxic for the patient. Until now, only leachable studies for SF animal cell-based productions of therapeutic proteins (in the majority monoclonal antibody productions with Chinese Hamster Ovary (CHO) cells) have been published (Steiger and Eibl 2013 ; Eibl et al 2014 ; Jurkiewicz et al 2014 ; Tappe et al 2016 ). Blaschczock et al ( 2016 ) also investigated the growth of hMSCs with different bioreactor bag films, but these studies were conducted with serum-containing medium.…”

Section: Usp In Hmsc Productions For Allogeneic Therapiesmentioning

confidence: 99%

Manufacturing human mesenchymal stem cells at clinical scale: process and regulatory challenges

Jossen

Bos²,

Eibl

et al. 2018

Appl Microbiol Biotechnol

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157

135

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Human mesenchymal stem cell (hMSC)-based therapies are of increasing interest in the field of regenerative medicine. As economic considerations have shown, allogeneic therapy seems to be the most cost-effective method. Standardized procedures based on instrumented single-use bioreactors have been shown to provide billion of cells with consistent product quality and to be superior to traditional expansions in planar cultivation systems. Furthermore, under consideration of the complex nature and requirements of allogeneic hMSC-therapeutics, a new equipment for downstream processing (DSP) was successfully evaluated. This mini-review summarizes both the current state of the hMSC production process and the challenges which have to be taken into account when efficiently producing hMSCs for the clinical scale. Special emphasis is placed on the upstream processing (USP) and DSP operations which cover expansion, harvesting, detachment, separation, washing and concentration steps, and the regulatory demands.

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Section: Usp In Hmsc Productions For Allogeneic Therapiesmentioning

confidence: 99%