Single‐Use Equipment in Biopharmaceutical Manufacture

Eibl, Dieter; Eibl, Regine

doi:10.1002/9781119477891.ch1

Cited by 15 publications

(19 citation statements)

References 11 publications

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“…The application of and the interest in single-use (SU) technologies in biopharmaceutical industries have been growing since the first single-use wave-induced agitation bioreactor was launched in 1998 [1]. The first single-use stirred-tank bioreactor appeared in 2004 [2].…”

Section: Introductionmentioning

confidence: 99%

Applicability of a single‐use bioreactor compared to a glass bioreactor for the fermentation of filamentous fungi and evaluation of the reproducibility of growth in pellet form

Soerjawinata

Schlegel

Fuchs

et al. 2021

Engineering in Life Sciences

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The implementation of single-use technologies offers several major advantages, e.g. prevention of cross-contamination, especially when spore-forming microorganisms are present. This study investigated the application of a single-use bioreactor in batch fermentation of filamentous fungus Penicillium sp. (IBWF 040-09) from the Institute of Biotechnology and Drug Research (IBWF), which is capable of intracellular production of a protease inhibitor against parasitic proteases as a secondary metabolite. Several modifications to the SU bioreactor were suggested in this study to allow the fermentation in which the fungus forms pellets. Simultaneously, fermentations in conventional glass bioreactor were also conducted as reference. Although there are significant differences in the construction material and gassing system, the similarity of the two types of bioreactors in terms of fungal metabolic activity and the reproducibility of fermentations could be demonstrated using statistic methods. Under the selected cultivation conditions, growth rate, yield coefficient, substrate uptake rate, and formation of intracellular protease-inhibiting substance in the single-use bioreactor were similar to those in the glass bioreactor.

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Section: Introductionmentioning

confidence: 99%

Applicability of a single‐use bioreactor compared to a glass bioreactor for the fermentation of filamentous fungi and evaluation of the reproducibility of growth in pellet form

Soerjawinata

Schlegel

Fuchs

et al. 2021

Engineering in Life Sciences

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“…The introduction of single‐use equipment offer alternatives to multiple‐use production systems made of stainless steel. Early adopters published a series of research reports in which the attraction of this technology was described . The advantages of installing single‐use production lines in biotechnological production plants were summarized from Whitford .…”

Section: Discussionmentioning

confidence: 99%

Development of a novel disposable filter bag for separation of biomolecules with functionalized magnetic particles

Shaikh¹,

Kampeis²

2017

Engineering in Life Sciences

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The integration of disposable magnetic filters in combination with functionalized magnetic particles represents a fast and cost-effective alternative for enzyme purification in comparison to solid/liquid separation by means of centrifugation followed by chromatographic purification. The main advantage of the particle-based process is the solid/solid/liquid separation in one step combined with disposable equipment. Furthermore this combination provides the possibility to also process biocatalytic reactions in cell-containing media into disposable equipment with preimmobilized enzymes onto the magnetic particles. The focus of the presented study is on the design and performance of a disposable filtration unit consisting of a plastic bag with an inlet and outlet and a stainless steel filter matrix. During magnetic separation, the magnetic particles selectively retard at the filter matrix due to the magnetic force, which counteracts the drag force. It was found that the length of a lengthwise aligned filter matrix should be longer than the magnetic pole surfaces in fluid flow direction. Hereby, a filtration capacity of 5.6 g magnetic particles was measured with a loss of below 0.5%. Introducing a two-phase flow optimizes the cleaning of the bag after a magnetic filtration. The procedure offered a high cleaning efficiency. Herewith, the cleaned filter unit could be discarded with minimum losses of product and magnet particles.

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“…In the process, the liquid containing hiPS cells is retained in suspension in a vessel. The retention vessel, tubes, and filling needles are single‐use products, that is, precleaned and sterilized, one‐way use, and resin‐made materials (Eibl & Eibl, 2011). The filling is carried out using a peristaltic pump, and the system is equipped with multiple filling needles to fill multiple vials simultaneously.…”

Section: Methodsmentioning

confidence: 99%

Apoptosis‐based method for determining lot sizes in the filling of human‐induced pluripotent stem cells

Sugiyama

Shiokaramatsu

Kagihiro

et al. 2020

J Tissue Eng Regen Med

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Standardization in process design and operation is needed in the commercial production of human-induced pluripotent stem (hiPS) cells. Lot sizing in the filling of hiPS cells into containers, a part of the preservation process, also needs to be standardized because of the temporal changes in cell quality during the process. Here, we present an apoptosis-based method that can determine lot sizes in the filling of hiPS cells considering temporal changes in cell quality. Two indicators were developed for (i) the cell quality change using reactive oxygen species (ROS) measurement and (ii) the cell survival and probability of filling success, which are parts of the lot-sizing problem. Using computational simulation, a map out of the optimal lot size was produced that minimized the expected production costs at a given cell demand and an acceptable change in cell quality. At a filling temperature of 4 C, the largest possible lot size was calculated as 6 L (corresponding to a filling time of 125 min). The results of a sensitivity analysis recommended cold filling or the addition of an antioxidant. The presented method is effective to determine the lot size considering the change in cell quality during filling. The study uniquely combines the experimental results with mathematical modeling and computational simulation techniques. The map out of the optimal lot size could guide the development of industrial filling processes of hiPS cells.

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Single‐Use Equipment in Biopharmaceutical Manufacture

Cited by 15 publications

References 11 publications

Applicability of a single‐use bioreactor compared to a glass bioreactor for the fermentation of filamentous fungi and evaluation of the reproducibility of growth in pellet form

Applicability of a single‐use bioreactor compared to a glass bioreactor for the fermentation of filamentous fungi and evaluation of the reproducibility of growth in pellet form

Development of a novel disposable filter bag for separation of biomolecules with functionalized magnetic particles

Apoptosis‐based method for determining lot sizes in the filling of human‐induced pluripotent stem cells

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