Bioreactors for Mammalian Cells: General Overview

Eibl, Dieter; Eibl, Regine

doi:10.1007/978-3-540-68182-3_3

Cited by 15 publications

(10 citation statements)

References 72 publications

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“…To overcome some of these challenges, several single use bioreactors (SUB) are being currently evaluated. 97,98 Companies marketing these systems include GE Healthcare, Sartorius, HyClone, Hynetics, ATMI, Xcellerex, Applikon and CELLution. Disposable technologies offer significant advantages over traditional fixed plant equipment, particularly at pilot scales of operation.…”

Section: Process Characterization and Validationmentioning

confidence: 99%

Cell culture processes for monoclonal antibody production

Vijayasankaran

Shen

et al. 2010

mAbs

615

409

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Animal cell culture technology has advanced significantly over the last few decades and is now generally considered a reliable, robust and relatively mature technology. A range of biotherapeutics are currently synthesized using cell culture methods in large scale manufacturing facilities that produce products for both commercial use and clinical studies. The robust implementation of this technology requires optimization of a number of variables, including 1) cell lines capable of synthesizing the required molecules at high productivities that ensure low operating cost; 2) culture media and bioreactor culture conditions that achieve both the requisite productivity and meet product quality specifications; 3) appropriate on-line and off-line sensors capable of providing information that enhances process knowledge; and 4) good understanding of culture performance at different scales to ensure smooth scale-up. Successful implementation also requires appropriate strategies for process development, scale-up and process characterization and validation that enable robust operation that is compliant with current regulations. This review provides an overview of the state-of-the art technology in key aspects of cell culture, e.g., engineering of highly productive cell lines and optimization of cell culture process conditions. We also summarize the current thinking on appropriate process development strategies and process advances that might affect process development.

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Section: Process Characterization and Validationmentioning

confidence: 99%

Cell culture processes for monoclonal antibody production

Vijayasankaran

Shen

et al. 2010

mAbs

615

409

View full text Add to dashboard Cite

show abstract

“…97,98 Companies marketing these systems include GE Healthcare, Sartorius, HyClone, Hynetics, ATMI, Xcellerex, Applikon and CELLution. Disposable technologies offer significant advantages over traditional fixed plant equipment, particularly at pilot scales of operation.…”

Section: Process Characterization and Validationmentioning

confidence: 99%

Cell Culture Processes in Monoclonal Antibody Production

Li¹,

Shen²,

Amanullah³

2013

Pharmaceutical Sciences Encyclopedia

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This chapter outlines cell culture processes in monoclonal antibody production. Cell culture process development starts with cell line generation and selection, followed by media and culture condition optimization in small‐scale systems, including 96‐well plate, shaker flasks, and bench‐scale bioreactors, for high throughput screening purposes. Once the process conditions are defined, the process is often transferred to the pilot scale to get scale‐up information and to produce toxicology materials and later to cGMP manufacturing for production of clinical material. As development of a commercial cell culture process for production of a biological product is completed at the laboratory and pilot scales, the commercialization process begins with process characterization, scale‐up, technology transfer, and validation for the manufacturing process. The strong demand of therapeutic antibody production, relatively modest titers, and reduction of cost of goods has resulted in a trend toward large‐scale manufacturing. Today, the largest biotech companies are using several hundred to 2,000 L scale bioreactors for early clinical production and 10,000‐25,000 L stirred tank bioreactors to produce commercial products.

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“…In clinical or production-scale biotechnology facilities, a number of disposable bioreactors have been suggested (D. & R. Eibl, 2009). Disposable bioreactors have advantages such as high flexibility, easy handling, low risk of cross contamination and saving time and cost, which are ascribed to sterility of the culture container (Eibl et al, 2010).…”

Section: Discussionmentioning

confidence: 99%

Combined automated culture system for tubular structure assembly and maturation for vascular tissue engineering

Baba

Mikhailov

Sankai

2018

JBSE

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Development of the robust yet practical tissue culture systems for vascular grafting is one of the major challenges for biomedical engineering. The following questions should be solved in priority: (1) flexibility of the tissue reservoir allowing dynamic stretching, (2) seeding of cells and extraction of tissues should be easy and safe, (3) system must allow morphological observation in real time, (4) maintenance of metabolic activity of tissues should be performed automatically. In our study, we attempted to solve these problems designing in vivo-like culture chamber made of PDMS, and developed an integrated system with a perfusion bioreactor and a small digital microscope. We developed disposable cell chamber with following qualities: transparent, autoclave-sterilizable, non cell-adhesive, and having low autofluorescence. The polyacetal mold made it possible to prepare a chamber hosting the tissue of the desired shape and size. In our case, a porous tube made from PTFE was fixed inside the chamber and tubular cell culture space was prepared for loading of preformed cell spheroids. Perfusion of the media within the porous tube continuously supplied the nutrients and oxygen to the spheroids. Growth and fusion of the cell spheroids inside the chamber can be observed real time by the small digital microscope and analyzed retrospectively by time-laps movies. We loaded batches up to 900 goat fibroblast spheroids into the system; growth, development and morphological fusion of the spheroids were followed out for 10 days. Removal of the tissue without disturbing its structural integrity was possible, and histological analysis revealed reasonable fusion degree between spheroids, and 72.5 % cell survival rate as estimated by TUNEL staining. In conclusion, our system has the basic performance necessary for culturing cell spheroids for tissue-engineered vascular graft.

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Bioreactors for Mammalian Cells: General Overview

Cited by 15 publications

References 72 publications

Cell culture processes for monoclonal antibody production

Cell culture processes for monoclonal antibody production

Cell Culture Processes in Monoclonal Antibody Production

Combined automated culture system for tubular structure assembly and maturation for vascular tissue engineering

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