Understanding opalescence measurements of biologics – A comparison study of methods, standards, and molecules

Author:

Kunz Patrick,Stuckenberger Eva,Hausmann Kerstin,Gentiluomo Lorenzo,Neustrup Malene,Michalakis Stylianos,Rieser Ruth,Romeijn Stefan,Wichmann Christian,Windisch Roland,Hawe Andrea,Jiskoot Wim,Menzen Tim

Publisher

Elsevier BV

Subject

Pharmaceutical Science

Reference26 articles.

1. AstraZeneca. Vaxzevria, COVID-19 Vaccine (ChAdOx1-S [recombinant]), product information. Annex 1. Summary of product characteristics, 37 pp. https://www.ema.europa.eu/en/documents/product-information/vaxzevria-previously-covid-19-vaccine-astrazeneca-epar-product-information_en.pdf (accessed 28 December 2021).

2. Opalescence measurements: Improvements in fundamental knowledge, identifying sources of analytical biases, and advanced applications for the development of therapeutic proteins;Barros;J Pharm Sci,2021

3. BioNTech. Comirnaty, INN-tozinameran, product information. Annex 1. Summary of product characteristics, 106 pp. https://www.ema.europa.eu/en/documents/product-information/comirnaty-epar-product-information_en.pdf (accessed 28 December 2021).

4. BioNTech. Factsheet 1 - Comirnaty Production & Ingredients, 2 pp. https://investors.biontech.de/static-files/240d45f5-19a4-46a2-8b28-75697da956b4 (accessed 28 December 2021).

5. Book of Standards Volume 11.01, 2018. Standard Test Method for Determination of Turbidity Above 1 Turbidity Unit (TU) in Static Mode. ASTM International, West Conshohocken, PA. 10.1520/D7315-17.

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