Q:On what basis does the FDA require the use for U.S.-licensed HSA and not allow the use of EU-licensed HSA, as an ancillary material in the manufacturing of gene and cell therapy products? Neither HSAs are manufactured from plasma collected in countries with TSE-related risk (UK, France, and Ireland), and both utilize a similar questionnaire to verify if the donor stayed in TSE-related risk countries in the relevant years.
美国FDA为什么要求使用美国许可的HSA，并不允许使用欧盟许可的HSA作为基因和细胞治疗产品制造过程中的辅助材料？两种HSA都不是从存在TSE相关风险的国家（英国、法国和爱尔兰）采集的血浆制成的，并且都使用类似的问卷来验证捐献者在相关年份是否停留在存在TSE相关风险的国家。
A:Thanks, Steven. This is a question that we get a lot. While we do consider other factors — so not just TSE risk but factors such as viral inactivation reduction processing steps, whether FDA-approved tests were used to test the donor material, and whether testing was performed in CLIA-certified labs, other than — like I said, other than just TSE risk, the FDA is becoming more flexible, particularly if the HSA is used upstream in the manufacturing process. We do continue to recommend that you use the safest, highest-quality HSA available, which in most cases would be a version that’s licensed in the U.S.
谢谢，Steven。我们经常遇到这样的问题。虽然我们确实考虑其他因素——不仅仅是TSE风险，还包括病毒灭活还原处理步骤、是否使用FDA批准的测试来测试供体材料，以及测试是否在CLIA认证实验室中进行等等——除了TSE风险之外，FDA变得更加灵活，特别是如果HSA用于制造过程的上游。我们继续建议您使用最安全、最高质量的可用HSA，大多数情况下，这将是在美国许可的版本。
This is particularly the case whenever the HSA is used as an excipient, since it will be directly administered to the patient. However, if you do choose to use a version of human blood-derived HSA that is not licensed in the U.S., in upstream manufacturing you may be able to do so, provided that you’re able to submit information supporting that donor eligibility, including donor screening and donor testing. The albumin manufacturing and the appropriate product standards do conform with that of U.S.-licensed HSA product, as described in 21 CFR 640.80 through 83.
特别是在HSA用作辅料的情况下，因为它将直接用于患者。然而，如果您选择使用在美国未经许可的人血源HSA版本，在上游制造中，只要您能够提交支持供体资格的信息，包括供体筛查和供体测试，您就可以这样做。白蛋白制造和适当的产品标准与美国许可的HSA产品一致，如21 CFR 640.80到83所述。
We’re really happy to become a little bit more flexible on this, and hopefully that will alleviate some issues that some sponsors have been having. Thanks, Steven.
我们非常高兴在这方面变得更加灵活，希望这将缓解一些申办方遇到的问题。谢谢，Steven。