BIOTECH PRODUCT REFERENCE STANDARDS
This article was originally published in The Gold Sheet
...are drawing attention early in product development as innovator firms realize their importance to later problem solving. The benefits of well-characterized reference materials in biopharmaceutical development and manufacturing control was a central theme at a recent "CMC strategy forum." FDA and industry experts discussed the evolving strategies for selecting and qualifying reference standards for new biotech products and the regulatory implications involved. Reference standard acceptance criteria, formulation and change management are among the challenging issues that drew debate. [A presentation by a Biogen Idec official on the various stages of reference standard development and the biotech firm’s program and procedures for handling the standards is included.]
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