Case Studies

Case Study #1 - Follow the Literature

Case Study #2 - Keep it Simple

Case Study #3 - Find the Right Talent

DEL BioPharma was engaged to design and synthesize a novel heterobifunctional poly(ethylene)glycol reagent.  One month after project initiation, DEL BioPharma became aware that a competing CRO was working on this project for 2 months (engaged one month prior to DEL BioPharma).  Within the next few weeks, DEL BioPharma began supplying the competing CRO with advanced intermediates and teaching the CRO the required chemistry to successfully complete the project.

At a later stage in this synthesis, the CRO was unable to repeat a reaction developed by DEL BioPharma.  The reaction was extremely time-sensitive and required monitoring.  Discussions with the CRO revealed that the reaction was not being monitored and was simply being run according to the time specified in the DEL BioPharma protocol.  The CRO was instructed to monitor the reaction using thin layer chromatography (TLC).  When implemented by the CRO, no improvement was noted in the reaction.  When evaluating another aspect of the CRO chemistry, DEL BioPharma realized that the CRO was monitoring the reaction using 20cm x 20cm preparative TLC plates requiring approximately 60 minutes to develop.  This was in contrast to analytical TLC plates that require 5 minutes to develop.  Overall, this time-sensitive reaction was being run at least one hour longer than required and resulted in formation of significant impurities.  When the CRO switched to analytical TLC plates, the reaction performed exactly as described.

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