Abstract
Background Mammalian fed-batch processes for monoclonal antibody (mAb) production rely on strategic feeding of several nutrients such as glucose, vitamins and amino acids to extend culture time and improve protein production [1]. In actual processes, L-cysteine and L-tyrosine are fed separately at alkaline pH due their low stability and low solubility at neutral pH, resulting in pH peaks and precipitations [2]. To simplify next generation processes, both amino acids have been chemically modified to enhance their respective stability and solubility profiles. Previous work has demonstrated that phosphotyrosine disodium salt (PTyr2Na) is a stable L-tyrosine derivative and can be used in neutral pH feeds without having a detectable impact on the culture performance or the mAb quality attributes [3]. Here, we present results obtained using a L-cysteine derivative in a neutral pH, single-feed system.
Highlights
Mammalian fed-batch processes for monoclonal antibody production rely on strategic feeding of several nutrients such as glucose, vitamins and amino acids to extend culture time and improve protein production [1]
Analysis of the L-cysteine derivative stability in neutral pH feed indicated no change in the derivative concentration nor L-cysteine/L-cystine release when stored over three months at room temperature or 4°C
Spin tube results were confirmed in bioreactors leading to higher final viabilities, increased titers and higher specific productivity with the single feed strategy
Summary
Mammalian fed-batch processes for monoclonal antibody (mAb) production rely on strategic feeding of several nutrients such as glucose, vitamins and amino acids to extend culture time and improve protein production [1]. L-cysteine and L-tyrosine are fed separately at alkaline pH due their low stability and low solubility at neutral pH, resulting in pH peaks and precipitations [2]. To simplify generation processes, both amino acids have been chemically modified to enhance their respective stability and solubility profiles. Previous work has demonstrated that phosphotyrosine disodium salt (PTyr2Na) is a stable L-tyrosine derivative and can be used in neutral pH feeds without having a detectable impact on the culture performance or the mAb quality attributes [3]. We present results obtained using a L-cysteine derivative in a neutral pH, single-feed system
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