2_Requirements 2088271.docx

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ReiThera (non GMP) batches of ChAd Ebola/Marburg in 2 L scale
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RFQ-NIAID-2088271
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3_FAR 52.212-5 JUL 2021.pdf PDF
Vendor rep 52.204-26 OCT 2020.pdf PDF
2_JA 2088271.docx DOCX document

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Requirement description:

· manufacture 3 batches of ChAd3 vector expressing Ebola and Marburg antigens at the scale of 2L in a disposable stirred tank bioreactor in non-GMP condition

· The required final concentration is 1x1012 vp/ml

· produced sub sequentially using the ReiThera’s cell Line ReiCell35.S as cell substrate for the ChAd3 vector production

· produced per every cultivation batches will be purified using the standard process of ReiThera

· The Bulk Drug Substance will be characterized in terms of: Titration by QPCR and Infectivity by Hexon Immunostaining

· performed in Process development laboratory under research-grade protocols.

Government will supply the seed (10e11 vp each) for each vector

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