Media and hydrolysates
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. This increases costs, significantly impacts production scheduling, and could delay the manufacture of drugs that may ultimately affect patients.
Despite these industry-wide issues, there is no harmonization or best practice and some companies have even optimized their methods for certain metals. This prompted BioPhorum to investigate the reasons why variation happens and develop an industry-agreed solution.
This paper gives you a strategy for a method development and outlines how to detect trace elements in chemically defined media and soy hydrolysates.
This ground breaking BioPhorum collaboration shared blinded data and compared analytical methods between biopharmaceutical and media manufacturers. The paper discusses the issues around trace elements and uses graphs to show the results of the project’s findings and the variability in identifying trace elements.
It looks at the fundamental issues you should consider when developing your method. Some of these are short-term, e.g., how much time, resources, and labor are available? Others have a longer-term impact, e.g., if an issue is identified, how will you stop it from happening again?
It also considers current best practices, which metals should be targeted, using inductively coupled plasma mass spectrometry, and key technical issues such as sample preparation, acid selection, and thermal hot block or microwave degradation.
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