Thermal sensitivity as a quality control attribute for biotherapeutics: The L‐asparaginase case-Reference-Cited by-同舟云学术

Thermal sensitivity as a quality control attribute for biotherapeutics: The L‐asparaginase case

Published:2019-09-12 Issue:1 Volume:12 Page:67-77
ISSN:1942-7603
Container-title:Drug Testing and Analysis
language:en
Short-container-title:Drug Test Anal

Author:

Yao Han¹,Wynendaele Evelien¹,De Spiegeleer Bart¹^ORCID

Affiliation:

1. Drug Quality and Registration (DruQuaR) group, Department of Pharmaceutical Analysis, Faculty of Pharmaceutical Sciences Ghent University Ghent Belgium

Funder

China Scholarship Council

Publisher

Wiley

Subject

Spectroscopy,Pharmaceutical Science,Environmental Chemistry,Analytical Chemistry

Link

https://onlinelibrary.wiley.com/doi/pdf/10.1002/dta.2691

Reference42 articles.

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2. Acute lymphoblastic leukaemia

3. Development of L-Asparaginase Biobetters: Current Research Status and Review of the Desirable Quality Profiles

4. Orphan designation for lonafarnib EU/3/18/2118; EMA.https://www.ema.europa.eu/en/medicines/human/orphan‐designations/eu3182118.

5. European pharmacopoeia 9th edition European Directorate for the Quality of medicines & HealthCare.2016;Strasbourg.

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