Case Studies

Case Study #1 - Follow the Literature

DEL BioPharma was engaged to evaluate why a literature compound failed to perform according to the reported biological assays.  The compound in question was prepared by an offshore CRO.  Analytical data included the following:

        - HPLC - high purity

        - MS - consistent with desired compound

        - NMR - consistent with desired compound

Because the compound in question was entirely aromatic, all signals in the NMR appeared in a region between 6-8 ppm.  Furthermore, while consistent with the structure, there were no signals that could be identified that conclusively confirmed the structure.  Following this evaluation, the client was asked if the CRO prepared the compound in question according to the literature protocol.  The CRO indicated that the literature synthesis was not used and a "shortened and more efficient" sequence was used instead.  Upon evaluation of the alternate synthesis, DEL BioPharma determined that a fully aromatic regioisomer was actually prepared.  When the compound was prepared according to the literature protocol, it performed exactly as expected.

Case Study #2 - Keep it Simple

Case Study #3 - Find the Right Talent

Case Study #4 - Efficient CRO/CMO Oversight Requires Chemistry Expertise

Case Study #5 - Keep Timelines Realistic

Case Study #6 - Begin with a Detailed RFP

Case Study #7 - Success Depends on 2-Way Communication