Handling the different requirements for commercial and investigational MNC collections by apheresis-Reference-Cited by-同舟云学术

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Handling the different requirements for commercial and investigational MNC collections by apheresis

Published:2024-08 Issue:8 Volume:26 Page:948-953
ISSN:1465-3249
Container-title:Cytotherapy
language:en
Short-container-title:Cytotherapy

Author:

Bobr Aleh^ORCID,Roberts Timothy,Koepsell Scott,Williams Shelly M.^ORCID,Schwartz Joseph

Publisher

Elsevier BV

Reference12 articles.

1. FDA. Package Insert-KYMRIAH. 2023; https://www.fda.gov/media/107296/download [accessed 10.06.23].

2. FDA. Package Insert-YESCARTA. 2023; https://www.fda.gov/media/108377/download [accessed 10.06.23].

3. FDA. Package Insert-TECARTUS. 2023; https://www.fda.gov/media/140409/download [accessed 10.06.23].

4. FDA. Package Insert-BREYANZI. 2023; https://www.fda.gov/media/145711/download [accessed 10.06.23].

5. FDA. Package Insert-ABECMA. 2023; https://www.fda.gov/media/147055/download] [accessed 10.06.23].

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1. Risk-Based Qualification of Cellular Starting Material Collection Sites: Tools to Determine Scope of Manufacturer Audits and Reduce Duplicative Efforts;Transplantation and Cellular Therapy;2024-09

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