In this community post, Rebecca Lim (Monash University and Hudson Institute of Medical Research, VIC, Australia) discusses her tips for adopting automation technology into your workflow.
One of the greatest issues faced by those of us working at the academic-industry interface of the cell therapies and regenerative medicine sector is taking that leap from the manual process that we have painstakingly developed to an automated system. We begin with a well-understood, albeit slow and lengthy protocol to an ideally rapid process that requires next to no supervision by the operator. If we are to be honest with ourselves, there is always some hesitation in making this transition particularly if the manual process has been in place for a significant length of time. This hesitation is understandable when you combine the time, upfront cost and know-how needed to re-optimize a process for a new technology with the cost of now-commonplace single-use disposables.
Suffice it to say that not all automated cell processing systems are created equal. Some devices are designed to be plug-and-play with the view that the user simply selects the program and away they go, while other devices are designed for the user to have full control of the process. Which way one leans will largely depend on the variability of the starting material. For example, would the user be processing expanded cell lines or apheresis material? Will the starting material always be fresh or frozen, or a mixture of the two? Some users have processes that place greater demand on the flexibility of the technology and this must be traded off for the convenience of the just-push-play variety.
Before one rushes into committing to the latest and greatest offerings for cell processing, it is worth considering the following. Is the technology mature? Or are you purchasing a new and still evolving bit of tech? There are pros and cons to each, but it is best to enter into this with a bit of clarity.
With more mature technology, you will likely be committing to a specific brand of device, consumables and reagents, and it is worth noting that these ‘single brand solutions’ tend to come at a significant cost. Furthermore, mature technologies can place greater demands on the user to modify their protocol to fit the capabilities of the device, consumables and reagents. The trade-off for this effort is (generally) an excellent training program to onboard the new technology and aftersales care by an experienced team who can pre-empt problems and assist with troubleshooting.
In contrast, being an early adopter of new technology can be challenging initially. On top of moving from a manual process to an automated one where the user must relinquish control of at least some aspects of the process, early adopters face additional challenges around process development such as limited knowledge around the optimal operating conditions for their cell product. This becomes increasingly relevant if the user is working on an uncommon cell type or using an uncommon process.
However, these initial hurdles may be worthwhile to early adopters who would be accessing new technology ahead of the pack and this is typically done alongside the developers, thus affording new insights into the technology that they have committed to. Being an early adopter may be more attractive to those working on novel or complex processes and/or products where a more bespoke approach is beneficial to delivering a high-quality product. Furthermore, users may have a wider choice of consumables and reagents with newer devices as developers are less likely to have those aspects locked down.
All this being said, adopting automation is no insignificant task and users must take into consideration their process, cell product variability and the limitations of the automated platform. My own experience in adopting both mature and emerging technologies has taught me a few valuable lessons:
- Protocol optimization will be needed even with the most mature of technologies;
- The cost of consumables can sometimes be the deciding factor rather than the technology itself;
- The most expensive technology may not be the most suitable technology so allocate time and resources to assess all suitable options;
- Process validation using new technology will be more complicated than with mature technology so permit ample time for this;
- Some automated solutions are released to the market prematurely so don’t be swayed by a big advertising campaign by a multinational company. Do the full road test and because users will always be the best judges of suitability.
I hope these tips are useful and will save you some teething problems as you go down the path of picking the best automated solution for your cell manufacturing process.