Animal Cell Culture Media

Vijayasankaran, Natarajan; Li, Jincai; Shawley, Robert; Chen, Aaron; Shiratori, Masaru; Gawlitzek, Martin; Li, Feng; Kiss, Róbert; Amanullah, Ashraf

doi:10.1002/9780470054581.eib030

Cited by 10 publications

(7 citation statements)

References 117 publications

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“…Vitamin B 6 comprises a group of six‐related compounds: pyridoxine ( 48 ), pyridoxal ( 49 ), pyridoxamine ( 50 ) (Figure ), and their respective 5′‐phosphate derivatives (Urbanski, ). At least one form is essentially required in CCM (Eagle, ; Vijayasankaran et al, ). These six compounds are all referred to as vitamers of vitamin B 6 , that is, they all have very different chemical functionalities but the same physiological activity as they are interconvertible in cellular systems.…”

Section: Vitamin B6mentioning

confidence: 99%

Vitamins in cell culture media: Stability and stabilization strategies

Schnellbaecher

Binder

Bellmaine

et al. 2019

Biotech & Bioengineering

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Nowadays, chemically defined cell culture media (CCM) have replaced serum‐ and hydrolysate‐based media that rely on complex ingredients, such as yeast extracts or peptones. Benefits include a significantly lower lot‐to‐lot variability, more efficient manufacturing by reduction to essential components, and the ability to exclude components that may negatively influence growth, viability, or productivity. Even though current chemically defined CCMs provide an excellent basis for various mammalian biotechnological processes, vitamin instabilities are known to be a key factor contributing to the variabilities still present in liquid CCM as well as to short storage times. In this review, the chemical degradation pathways and products for the most relevant vitamins for CCM will be discussed, with a focus on the effects of light, oxygen, heat, and other CCM compounds. Different approaches to stabilize vitamins in solution, such as replacement with analogs, encapsulation, or the addition of stabilizing compounds will also be reviewed. While these vitamins and vitamin stabilization approaches are presented here as particular for CCM, the application of these concepts can also be considered relevant for pharmaceutical, medical, and food supplement purposes. More precise knowledge regarding vitamin instabilities will contribute to stabilize future formulations and thus decrease residual lot‐to‐lot variability.

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Section: Vitamin B6mentioning

confidence: 99%

Vitamins in cell culture media: Stability and stabilization strategies

Schnellbaecher

Binder

Bellmaine

et al. 2019

Biotech & Bioengineering

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“…Several approaches can be used systematically, such as single-component titration, spent medium analysis, and medium blending. 47,48 Due to safety concerns related to transmissible spongiform encephalopathy (TSE) and other contaminants, bovine serum and animal-derived raw materials should be avoided if possible. After two decades of media development and host cell adaptation, fully chemically defined media consisting of amino acids, vitamins, trace elements, inorganic salts, lipids and insulin or insulin-like growth factors, have been developed and implemented in large-scale mAb production, but not all antibody production cell lines can achieve high yield in chemically defined media.…”

Section: Medium and Feeding Strategy Developmentmentioning

confidence: 99%

Cell culture processes for monoclonal antibody production

Vijayasankaran

Shen

et al. 2010

mAbs

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630

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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“…Development of “platform” processes that enable rapid process development and the optimization of volumetric productivity to minimize capital investment and maximize plant throughput are ongoing challenges facing cell culture engineers. Recent advances in cell line development and in the optimization of culture medium have enabled fed‐batch processes to operate at significantly higher volumetric productivities than previously realized . However, when culture medium is optimized for improving the productivity or robustness, it is necessary to ensure that the product quality has not changed significantly.…”

Section: Introductionmentioning

confidence: 99%

“…Recent advances in cell line development and in the optimization of culture medium have enabled fed-batch processes to operate at significantly higher volumetric productivities than previously realized. 1,6 However, when culture medium is optimized for improving the productivity or robustness, it is necessary to ensure that the product quality has not changed significantly. There is a significant body of literature on the effect of the cell culture process on product quality attributes such as N-glycosylation profile, 7 size distribution 8 and charge heterogeneity.…”

Section: Introductionmentioning

confidence: 99%

Effect of cell culture medium components on color of formulated monoclonal antibody drug substance

Vijayasankaran¹,

Varma²,

Yang³

et al. 2013

Biotechnology Progress

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As the industry moves toward subcutaneous delivery as a preferred route of drug administration, high drug substance concentrations are becoming the norm for monoclonal antibodies. At such high concentrations, the drug substance may display a more intense color than at the historically lower concentrations. The effect of process conditions and/or changes on color is more readily observed in the higher color, high concentration formulations. Since color is a product quality attribute that needs to be controlled, it is useful to study the impact of process conditions and/or modifications on color. This manuscript summarizes cell culture experiments and reports on findings regarding the effect of various media components that contribute to drug substance color for a specific monoclonal antibody. In this work, lower drug substance color was achieved via optimization of the cell culture medium. Specifically, lowering the concentrations of B-vitamins in the cell culture medium has the effect of reducing color intensity by as much as 25%. In addition, decreasing concentration of iron was also directly correlated color intensity decrease of as much as 37%. It was also shown that the color of the drug substance directly correlates with increased acidic variants, especially when increased iron levels cause increased color. Potential mechanisms that could lead to antibody coloration are briefly discussed.

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Animal Cell Culture Media

Cited by 10 publications

References 117 publications

Vitamins in cell culture media: Stability and stabilization strategies

Vitamins in cell culture media: Stability and stabilization strategies

Cell culture processes for monoclonal antibody production

Effect of cell culture medium components on color of formulated monoclonal antibody drug substance

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