Protein hydrolysates are an essential component in cell culture medium formulation during the manufacture of protein therapeutics. However, as they may be derived from microbial, plant or animal sources, variations in their composition are unavoidable. This poses a potential risk to biomanufacturing as cell lines and products may be sensitive to slight variations in the hydrolysate composition, which may have an impact on process performance...
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It is important for biomanufacturers to understand trace element variation within soy hydrolysates (by knowing the minimum, maximum and average concentrations), so they can determine if the degree of variation has an impact on their process. The knowledge gained through process characterization across the maximum variation found in soy hydrolysates can be evaluated to determine if it has an impact on the biomanufacturers’ process or product on a product-byproduct basis.
This is the first in a series of proposed hydrolysate white papers. The purpose is to educate users of hydrolysates of the various characteristics that they should be aware of to manage their processes. There are many parameters to consider within a hydrolysate. The intention is to start with data that can be collected on as many different hydrolysates used in the biopharmaceutical industry.