Liso-cel
What two main cell components are included in the liso-cel product?
CD8 and CD4 CAR-positive viable T cells.
For ide-cel, what is the component in its formulation that causes infusion reaction?
DMSO dimethylsulfoxide
What does RFI Stand for?
Release for Infusion
What must be done within 2 hours of starting to thaw liso-cel?
The product must be administered
How is ide-cel supplied for infusion?
In one or more cryopreserved infusion bags.
What is the ratio of CD8 to CD4 components in a liso-cel dose
1:1 ratio.
Is ide-cel a fixed volume product?
Ide-cel is not a fixed volume product.
Ide-cel is provided as a single dose for infusion containing a suspension of CAR-positive T cells in one or more infusion bags.
What biosafety guidelines apply to disposal of unused liso-cel or ide-cel?
Follow universal precautions and local biosafety guidelines for genetically modified human blood cells.
Is a laminar flow hood required for liso-cel product withdrawal?
No, but sterile technique must be followed.
How much of the contents of each ide-cel infusion bag should be given?
The full contents should be used for infusion.
What is the shelf life for Liso-cel?
13 Months
What is the recommended dose range for Ide-cel?
The recommended dose range is 300 to 510 × 106 CAR-positive T cells.
What should institutions do if they are not qualified for on-site liso-cel or ide-cel storage and need to postpone infusion?
Contact Bristol Myers Squibb for return shipment.
What should you do if liso-cel vials show damage, leakage, or unresolved clumping after thaw?
Stop and call Bristol Myers Squibb at 1-888-805-4555.
What are the infusion bag sizes available for Ide-cel?
50mL, 250mL, and 500mL
What is the appearance of the liquid in thawed liso-cel vials?
Slightly opaque to opaque, colorless to yellow, or brownish-yellow.
What is the maximum volume of DMSO that will be received by the patient?
12.5 mL of DMSO/Dose
The max total volume a patient can receive is 250 mL/dose, therefore the maximum volume of DMSO from the ide-cel infusion would be 250 mL × 5% = 12.5 mL of DMSO/dose
What must two site staff verify during the COI verification check before product thawing?
Patient JOIN ID, first and last name, and date of birth on product labels and RFI Certificate.
What is the total extractable volume of the lCD8 and CD4 components from the liso-cel vials?
4.6mL
Each vial contains 5 mL with a total extractable volume of 4.6 mL of CD8 or CD4 cells
How is each ide-cel infusion bag packaged?
Overwrapped with a transparent plastic sleeve and packed in a metal cassette.
What is the DMSO concentration of Liso-cel?
7.5% DMSO (v/v)
The liso-cel formulation contains 75% (v/v) Cryostor® CS10 [containing 7.5% dimethylsulfoxide (v/v)
What is the final DMSO concentration in ide-cel formulation?
5% dimethylsulfoxide (v/v).
In what substance's vapor phase are ide-cel and liso-cel stored before infusion?
They are stored in the vapor phase of liquid nitrogen
How long does the thaw process for each liso-cel vial take at room temperature, max?
Up to 45 minutes.
What rate is Ide-cel infused at?
Infused by gravity flow