Monitoring Outsourced Biomanufacturing: Sponsor/CMO Collaboration

  • 15th October, 2013

Further to my previous post on using Excel as a recording tool, one of the advantages of using this approach is in data collection from diverse locations particularly in the outsourced manufacturing environment.

As we see more and more CMO activites proliferating (with drug discovery and commercialization companies sponsoring/outsourcing their manufacturing to CMO's providing in clinical and commercial manufacturing services), there arise a need for better collaboration and continuous communication (almost in the real-time mode) between both the parties. With easy to configure Excel based process templates sponsor organizations can easily collect process data from their CMO counterparts in a near real time manner. Since most of the CMO's prefer to work on a paper based recording system as its practically unviable for them to invest in electronic batch recording system owing to multi-product nature of their business and constant changes in their product manufacturing pipelines, in our view this (Excel recording) approach is most economical in an outsourced environment.

With our ProcessPad platform the sponsors can provide a secure way of uploading the process data where both parties can have real time access to same process information. Sponsors can easily control the access to the system. A schematic of such a system is shown below:

Write to us if your organization is involved in outsourcing activity/services and you are looking for effective solutions for sharing and collaborating with your sponsors or CMO's.