REFERENCE STANDARD UNAVAILABILITY FOR FOLLOW-ON BIOLOGICS
This article was originally published in The Gold Sheet
...is a significant stumbling block on their regulatory pathway, analytical scientists are pointing out. Exploring the technical challenges involved in developing and assessing follow-on protein products at a recent FDA/NYAS/NIST workshop, regulators, academics and industry experts addressed the pivotal role reference materials play in active ingredient analysis and comparison. Along with the reference standard issue, the FOB workshop focused on: * analytical techniques to assess molecular heterogeneity * the effect of the manufacturing process on the product * impurities and contaminants, and * bioassays and potency. [A summary of the follow-on biologics workshop by CDER’s Emily Shacter is included.]
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