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Why BioPhorum’s trace element approach will save you time, money and wasted batches

Drug products can be heavily impacted when raw materials cause variability – anecdotal evidence suggests that batches worth millions of dollars are sometimes discarded due to trace elements coming through the supply chain. Not only does this increase costs and significantly impact production scheduling, but it could delay the manufacture of drugs that may, ultimately, impact patients. Yet, despite these industry-wide issues, there is no...

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Media and hydrolysates

This paper discusses the issues around trace elements and gives a suggested approach for developing a method for analyzing trace elements in cell culture media and hydrolysates. The approach is based on a ground breaking BioPhorum collaboration that shared blinded data and compared analytical methods between biopharmaceutical and media manufacturers.

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Bringing clarity to trace element variations of hydrolysates

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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Raw Materials: Trace element variation of soy hydrolysate used in biopharmaceutical manufacturing

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.

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