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How to fix the weak link of the chain?
In a recent conversation with a supervisor of stem cell laboratory, I learnt about the difficulty they have in getting a key reagent in cell processing. As a supervisor, you can relate to how stressful is being unable to process the precious products of patients.
Like approved disposables, approved reagents are a life line to every cell processing laboratory, and to every laboratory for that matter. A shortage of reagent can paralyze the cell processing laboratory, and potentially, the entire cell therapy program. “Reagents” is a volatile component of cell therapy because their availability depends on multiple factors. Most of these factors such as product recalls, shortage, and international transport affairs are outside the circle of impact of the laboratory supervisor.
How to Reduce the Reagent Volatility?
There are few practices that are within your circle of impact, implement them to reduce the impact of reagent fluctuation. But before doing this, you first need to identify the reagent that are most critical and vulnerable. Once you build this list, try to implement the following:
- Connect: establish connections with the nearby stem cell processing facilities to build a network that can back each other up when needed.
- Qualify vendors: if possible, identify and qualify new vendor that can supply the same brand or similar reagent type to the ones you use.
- Qualify reagent: identify a substitute reagent for each reagent on your list, then use this substitute as a back up reagent when the primary one is unavailable.
- Regular supply: placing orders take time and effort, and may even require a quote every time you order. You can instead place a blanket order to a vendor to deliver a certain amount of your reagent on a regular basis. This cuts down the time you spend on ordering, and also gives the vendor a chance to plan and stock for long term supply.
- Policy driven: work with your quality assurance representatives to develop a policy that (i) allows you to receive reagent from another cell processing laboratory, and (ii) defines the requirements for such receipt to be approved. Additionally, this policy should (iii) allows you to lend reagent to another cell processing facility, and (iv) defines the procedure to update your reagent database.
Implementing these practices could greatly reduce the occasions of reagent shortage. With the cell therapy being such an evolving field, these practices become essential and an ongoing process.
Let us know if we missed anything, or if you would like a specific subject to be discussed, write to us.
About the author
Naseem Almezel, earned his MSc degree in Cellular Therapies in 2010, since then his career focus is to support Bone Marrow Transplant and Oncology programs. Naseem likes to work in the lab doing translational research, or in the cleanroom doing GMP production. When he is not working, Naseem likes to read and to spend time outdoors. Find more about Naseem here