Q38-46: Cell Product Analysis

*This section applies only to products that are not commercially available. If a commercially available product (e.g., Kymriah® or Yescarta®, Tecartus^TM, Breyanzi^TM, Abecma®) or pre-commercial product was selected in question one, continue to question 47.

Question 38: Is the percentage of genetically modified cells known?

Answered for genetically engineered/manipulated cells only. The percentage of genetically modified cells, or transfection efficiency, is calculated as a percentage of transfected cells from all cells in the sample. There are a number of methods used to determine transfection efficiency including flow cytometry, fluorometry, microscopy, real-time quantitative PCR, etc.

This information will be available from the cell processing lab that is manufacturing the cellular product and may not be available in the medical record. Indicate Yes if transfection efficiency was done. If transfection efficiency was not done or it is not known if transfection efficiency was performed, select No or Unknown, respectively and continue with question 42.

Question 39: Date:

Specify the date (YYYY-MM-DD) when sample was taken for the transfection efficiency testing.

If the exact date is unknown, please view General Instructions, General Guidelines for Completing Forms for more information on reporting partial and unknown dates.

Question 40: Percent of genetically modified cells:

Report the percent of genetically modified cells in the product. Round to the nearest whole number.

Question 41: Was the target percent of genetically modified cells achieved?

The target percent if genetically modified cells, or transfection efficiency target, will be defined by the protocol. Indicate Yes or No if the target defined by the protocol was met.

Question 42: Was viability of cells done?

Indicate if the viability of cells was done. If the product was cryopreserved, viability post-thaw should be reported.

If the viability of the cells was analyzed, select Yes and continue with question 43. If viability of the cells was not done or it is not known if completed, indicate No or Unknown, respectively and continue with question 47.

Question 43: Date:

Specify the date (YYYY-MM-DD) when the sample was analyzed to determine viability, not the date the results are available.

If the exact date is unknown, please view General Instructions, General Guidelines for Completing Forms for more information on reporting partial and unknown dates.

Question 44: Viability of cells:

Report the percent viability. Round to the nearest whole number.

Question 45-46: Method of testing cell viability:

Indicate the method of testing viability.

7-AAD (7-aminoactinomycinD) and Propidium iodide are compounds that can stain dead cells but will not cross the membrane of living cells. Cytometric techniques are used to calculate the percentage of viable cells in a sample.

Trypan Blue is a technique where the dead cells become stained when in contact with the compound, but living cells remain impermeable to the dye. Cells are counted under a microscope to determine the percentage of viable cells in a sample.

If both methods of viability testing are performed, report 7-AAD results. If the cell viability was tested using a different method, select Other method and specify the method in question 46 and continue with question 47. If the method is not known, select Unknown and continue with question 47.

Section Updates:

Question Number	Date of Change	Add/Remove/Modify	Description	Reasoning (If applicable)
42	4/11/2022	Add	Instruction added for the preferred timepoint of viability when the product was cryopreserved: If the product was cryopreserved, viability post-thaw should be reported.	Added for clarification

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