University of Wisconsin–Madison

Synthesis/Radiolabeling: 10 Things you Should Know Before Contracting Custom Synthesis

When: July 13, 2017 11:00am CST

Companies often need to arrange for the synthesis of test substances to support research and development efforts. Synthesized test materials range from active ingredients, intermediates, fine chemicals and reference standards to impurities and metabolites. Depending on the type and depth of data required, custom synthesized materials may need to be radiolabeled, stable-labeled or non-radiolabeled; and depending on the type of study, a GxP manufacturing environment may be necessary. There are many important decisions to consider before proceeding with a contract for custom synthesis.  This presentation addresses communication, regulatory requirements, strategic use of isotopes, position of radiolabel, timing; scalability; re-purification/characterization; metabolite and impurity reference standards; analytical support; intellectual property and more.

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