The 7 ways to get an error-free process

Due to the product nature and process complexity, many cell and gene therapy processes remain manual, particularly for advanced therapy medicinal products (ATMP) and more than minimally manipulated products. Even those process that were developed as partially automated (e.g., bioreactor), significant portions of those processes remain manual. This means that the final product quality depends greatly on the personnel of the cell therapy lab.

So, how can the personnel of stem cell lab live up to expectations and excel in their roles?

Stem cell therapy lab is part of a larger system that is designed to ultimately provide the cell therapy service. The detailed structure may vary from one institute to another, but the main components remain the same:

1. Bone Marrow Transplant (BMT) Clinic
2. Stem Cell Collection Facility
3. Stem Cell Processing Facility

Personnel of each of the components have their unique responsibilities, we will next dive into how stem cell lab personnel can thrive in their roles.

YOUR best practices

Below is a list of practices that you may employ immediately:

a) Know your responsibilities: when you are first hired, your responsibility is exclusively training related, but it starts to grow gradually as you get trained. Know your responsibility and stick to it.

b) Know your timeline: always refer to your training plan to know when you are expected to do what with whom. If you don’t have a formal plan, seek this information from your supervisor.

c) Prepare: each cell therapy process has its own requirements, prepare well to avoid unnecessary errors.

d) Communicate: maintain an active communication with those involved:

• Your supervisor: share any concerns you may have about your training, the process, material, etc.
• Facility manager: have an up-to-date schedule of facility maintenance, cleaning, etc.
• Quality Control: inform the quality control representative of your processing schedule to coordinate your and their activities.
• Quality Assurance: inform the quality assurance representatives of processing plan so they could review / release your product.
• Testing Labs: inform the testing labs of upcoming testing / timing so they could schedule their staff.
• Collection facility: communicate with the collection staff to know when the product is expected to arrive at your facility.
• BMT Clinic: Communicate & update the clinicians of processing progress so they may plan the patient preparation work.

e. See the whole picture: occasionally you get involved in details and forget the reason behind it, or what goes next. From time to time try to take a step back and observe the whole process; this helps you identify areas of improvement or near mis situations.

f. Take initiative: because of your role and experience, sometimes you are the best person to lead process improvement process. Take the initiative, discuss with your supervisor, and start getting things better.

g. Cross Train: being trained on related processes improves your chances of spotting areas of improvement, it also makes you highly skilled technologists.

h. Follow up and follow through: when you communicate, follow through, make adjustments until you achieve the goal.

The summary

To summarize, when you know your responsibilities, know your timeline, prepare, and communicate, you meet expectations. 

When you see the whole picture, take initiative, and cross train, you exceed expectations. 

When you follow up & follow through, you are ready to excel to a higher responsibility.

These practices can actually be adopted by any lab personnel and not only stem cell lab personnel; divisions names may vary but the practices are almost universal.

Let us know if we missed anything, or if you would like a specific subject to be discussed, write to us