Thank you @Tapan Das! We did discuss that DMSO was used as a cryoprotectant and we would have loved to have you in the discussion. @Robert Strickley noted the trend of using DMSO started in 2017 and that DMSO is not used in all CAR-T therapies. We also talked about the limited number of parenteral DMSO suppliers.
Gvoke was also approved in 2019 (see below) and MEKINIST (trametinib) tablets for oral use has 0.5635 trametinib dimethyl sulfoxide equivalent to 0.5 mg of trametinib nonsolvated parent.
|
2019
|
Gvoke™
|
Subcutaneous
|
95%
|
0.2 mL
|
Pre-filled syringe
Auto-injector
|
I will add this topic to the next GCTP CMC Subteam meeting. If anyone would like to join the GCTP CMC Subteam, let me know!
Allison
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Allison Radwick Ph.D.
Sr Regulatory & Policy Comms Mgr
USP
Rockville MD
[email protected]Disclaimer: Opinions expressed are solely my own and do not express the views or opinions of my employer.
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Original Message:
Sent: 08-22-2023 15:21
From: Tapan Das
Subject: Increasing use of DMSO in CAR-T formulations
I am probably stating the obvious (too bad I couldn't join the discussion)!
The source is a cryoprotectant (containing DMSO) for the CAR T drug product (frozen).
The actual percentage in the infusion might differ depending on how the infusion solution is prepared from the DP.
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Tapan Das, Ph.D., FAAPS
Bristol Myers Squibb
Disclaimer: Opinions expressed are solely my own and do not express the views or opinions of my employer
Original Message:
Sent: 08-21-2023 22:00
From: Allison Radwick
Subject: Increasing use of DMSO in CAR-T formulations
The Excipients Community recently had a knowledge exchange and the topic of DMSO in parental formulations brought up by @Robert Strickley. It is an excipient in 7 commercial products since 2017 at concentrations at 5% or greater for an intravenous infusion. There is no maximum IV infusion listed in the FDA Inactive Ingredients Database. Can anyone comment about using DMSO in these formulations?
Year | Product | Route of Administration | % DMSO Injected | Amount of DMSO Injected | Application |
2017 | Yescarta® | IV infusion | 5.0% | ~ 3.4 mL | CAR-T therapy |
2017 | KYMRIAH™ | IV infusion | 7.5% | ~ 2.2-11 mL | CAR-T therapy |
2020 | Tecartus™ | IV infusion | 5.0% | ~ 3.4 mL | CAR-T therapy |
2021 | BREYANZI | IV infusion | 6.0% | | CAR-T therapy |
2021 | Abecma® | IV infusion | 5.0% | | CAR-T therapy |
2022 | Skysona® | IV infusion | 5.0% | ~ 2.0 mL | CAR-T therapy |
2023 | Omisirge® | IV infusion | 10% | ~ 3.5 mL | CAR-T therapy |
Thank you from the inquiring minds in the Excipients Community!
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Allison Radwick Ph.D.
Sr Regulatory & Policy Comms Mgr
USP
Rockville MD
[email protected]
Disclaimer: Opinions expressed are solely my own and do not express the views or opinions of my employer.
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