From:
To: a nit cou.15 11110 EEE 21 1 05 unse ac
Subject: Impact Röntgenstrahlung
Date: Mittwoch, 6. Oktober 2021 17:28:26
Attachments: BNT-Europe,png
U-In-Bug.png
Twi Social I R jed S ool

Sie hatten bei unserem letzten Jour Fixe eine Frage zu Röntgenstrahlung gestellt, dazu können wir folgende
Informationen übermitteln:

Similar biologics showed

 

reasonable chemical and colloidal stability when exposed to

multiples of the possible X-ray radiation levels resembling cosmic radiation or personal,

baggage, or cargo screening methods.

Independent studies have demonstrated the protective effect of disaccharides, such as sucrose, in protecting
radiation-induced DNA damage in cells, and the cellular functionality by gamma-rays.2 Important to note that x-
rays are generally low energy compared to gamma-rays, hence less penetrating.3

Based on the rationale and references cited above, it is BIoNTech’s position that exposure to X-ray during
routine transportation of frozen BNT162b drug product can be assigned a low risk for affecting product quality.

References:

2 Yoshinaga et. al., Biosci. Biotech. Biochem., 61 (1), 160-167, 1997.

3 IARC Working Group on the Evaluation of Carcinogenic Risks to Humans. lonizing Radiation,
Part 1: X- and Gamma (y)-Radiation, and Neutrons. Lyon (FR): International Agency for
Research on Cancer; 2000. (IARC Monographs on the Evaluation of Carcinogenic Risks to
Humans, No. 75.) X-radiation and y-radiation. Available from:
https://wwuw.ncbi.nim.nih.gov/books/NBK401331

Mit besten Grüßen

 

Anschrift:
BioNTech Europe GmbH
Friedrichstraße 68

10117 Berlin
Germany

a8

Sitz der Gesellschaft: BioNTech Europe GmbH, An der Goldgrube 12, 55131 Mainz, Germany
Amtsgericht Mainz HRB 46774 » USt.-IdNr. DE 306 280 123
Geschäftsführer: Dr. Sierk Poetting - Dr. Michael Boehler - Jan Kürschner

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