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Survey to Identify Process Analytical Technologies (PAT) currently used in Cell & Gene Therapy Manufacturing

ISCT’s Process Development & Manufacturing Committee solicits your participation in the following survey to determine the current state of “Process Analytical Technologies (PAT) in Cell & Gene Therapy Manufacturing”.
 
Fundamental analytical challenges exist when manipulating and expanding cells ex vivo for therapeutic treatment. Wider manufacturing makes extensive use of Process Analytical Technology [PAT] to control process parameters that determine product yield and quality. This survey aims to better understand what features of the product or process are monitored during Cell & Gene Therapy [C&GT] manufacturing, and how these measurements contribute to the control of the process. Your feedback will allow us to define the current state of the industry, identifying the most commonly utilised and desired measurements as well as the challenges associated with acquiring this data. This survey will also serve to inform on the future direction of PAT in C&GT manufacturing.
1.What is the nature of the company, lab, or institution you are working in?
2.Where is your institute, lab or company located?
3.Which position or title do you hold with your company, lab or institution?
4.What is your lead product candidate?
5.What areas do you provide services or technologies to? (Choose all that apply)
6.What stage of development is your lead cell or gene therapy product?
7.Where in your process development and/or manufacturing process do you collect and/or monitor sensor data?
8.Are you using manual or automated processes for modification and/or expansion of your cell product?
9.Are your modification & follow on expansion technologies integrated?
10.What are you monitoring in your modification process?
11.What are you monitoring in your expansion process?
12.What type of sensors or technologies are you using to measure pH?
13.What type of sensors or technologies are you using to measure temperature?
14.What type of sensors or technologies are you using to measure glucose?
15.What type of sensors or technologies are you using to measure lactate?
16.What type of sensors or technologies are you using to measure dO2?
17.What type of sensors or technologies are you using to measure dCO2?
18.What type of sensors or technologies are you using to measure ammonia?
19.What type of sensors or technologies are you using to measure glutamine?
20.What type of sensors or technologies are you using to measure glutamate?
21.What type of sensors or technologies are you using to measure amino acids ?
22.What type of sensors or technologies are you using to measure cell viability ?
23.What type of sensors or technologies are you using to measure cell number ?
24.What type of sensors or technologies are you using to measure phenotype (biomarkers relevant to expansion) ?
25.What type of sensors or technologies are you using to measure pressure?
26.What type of sensors or technologies are you using to measure secreted factors?
27.What type of sensors or technologies are you using to measure osmolality?
How are you measuring it?

In-Line: In-line measurement involves placing a probe, patch or flow-based sampling interface directly into or in-line with the process or product flow.

At-Line: At-line measurement requires manually or automatically collecting a sample or samples and performing analysis separate from the process. At-line analysis is completed at or near the process.

Off-Line: Off-line measurement requires manually collecting a sample or samples and performing analysis separate from the process. Off-line analysis involves most physical separation between the process and analysis of the sample. Instead of analysing the sample at the production facility, offline measurement involves taking a sample/samples to be analysed in a formal separate lab setting.
28.What kind of measurements are most utilised during your modification process?
29.What kind of measurements are most utilised during your expansion process?
30.Please check all applicable measurements that you are monitoring in-line during expansion?
31.Please check all applicable measurements that you are monitoring at-line during expansion?
32.If you are using At-line sensors – how often do you take measurements (please indicate numerical frequency)?
33.If you are using At-line sensors are you using automated or manual sampling?
34.Please check all applicable measurements that you are monitoring off-line during expansion?
35.If you are using off-line sensors – how often do you take measurements (please indicate numerical frequency)?
36.If you are using off-line sensors are you using automated or manual sampling?
37.Are you utilising the data to drive decision making in your modification processes?
38.If yes, what data are you using
39.Are you utilising the data to drive decision making in your expansion processes?
40.If yes - what data are you using
41.Is there data that you would like to collect using sensor technology to improve your modification process, that you currently can’t?
42.Is there data that you would like to collect using sensor technology to improve your expansion process, that you currently can’t?