On a previous project, I was tasked with facilitating the technology transfer of a commercial process from a customer site to the CMO manufacturing plant. The scope of the project was for the successful implementation of the upstream process into a three (3) train, 5000L working volume production suite.
Prior to undertaking the project, the site had a string of tube sealer failures while performing aseptic connections throughout the cell expansion and fermentation stages. Measures were put in place to ensure that manufacturing personnel performed additional test welds, and subsequently, multiple welds prior to disconnecting spinner flasks, media bags, etc. This turned out be a cumbersome and lengthy process, especially when dealing with time sensitive operations.
I viewed this tech transfer as an opportune time to introduce single-use, disposable technology into the facility. The idea of disposable technology was not a welcome one as it was “out-of-the-norm”. I had to start small – aseptic connectors. Flip some tabs, click a few pieces together, pull a tab, and voila, a sterile connection. No more time spent on warm up times, test welds or cuts and less risk to the process.
After reviewing the process from out-of-freeze to concentration of product, I realized that there would be a number or feeds connected to the bioreactors throughout the process, with the added impetus that all were time sensitive and deemed critical.
Introducing a single-use-technology into this process (and subsequently the entire facility) would provide ease-of-use to the manufacturing associates and also allow them to remain within the established processing parameters, avoiding unnecessary deviations, or much worse, the loss of a batch. This was enough rationale to quiet the concerns of MS&T personnel and to proceed with securing vendor samples. I found the parts I needed and ensured all information was in place (BOM, ingress studies, leachable/extractable memos, delivery timelines, etc.) for a successful kickoff to the manufacturing campaign.
As the out-of-freeze date inched closer and the vendor delivery timeline grew more and more distant, I realized that our campaign would need some fine tuning in order to meet the customers’ expectations. Luckily, we had the foresight to build into our batch records the option to weld connections, avoiding the need for planned deviations for each run. Sooner or later it became evident that the parts I ordered were not going to arrive in time. I had to communicate this to the senior leadership team and face the fact that my idea would not work.
So what did I learn?
- Always dual source suppliers whenever possible. The more options, the better.
- Use suppliers with local support and/or presence. Proximity iskey when it comes to deliverables.
- Get the entire cross-functional team involved early. This was my major oversight. I had my lead times in place, but waited too long to involve my supply chain group.
- Big name companies are not necessarily the best. I had the option to go with a smaller vendor but chose the big name as I perceived they would be more reliable.
- Ensure training is in place. Although the parts didn’t arrive in time for the run, training was crucial to ensure our personnel were aware of what would be arriving.
Written By: Gregory Fischer, Consultant I