Academic Journal
Driving change in dtap batch release testing
العنوان: | Driving change in dtap batch release testing |
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المؤلفون: | Bekeredjian-Ding, Isabelle, Friedrichs, Bärbel, Matheis, Walter, Becker, Björn, Kamp, Christel, Ticha, Olga, Öppling, Volker |
المصدر: | Vaccine Technology VIII |
بيانات النشر: | ECI Digital Archives |
سنة النشر: | 2022 |
المجموعة: | Engineering Conferences International: ECI Digital Archives |
مصطلحات موضوعية: | batch release, DTaP vaccine, serology, 3R, Raman spectroscopy |
الوصف: | The complexity of vaccine manufacturing has raised the need to drive standardization and quality control requirements as well as batch release of vaccines. The purpose of release testing is to ensure that efficacy and safety of the vaccine product are maintained in all batches. Classical testing includes challenge experiments in animals that provide proof of vaccine potency and identify subpotent vaccines. However, novel concepts such as “consistency testing” question the continued need for in vivo experiments and propose to implement rigorous QC for lot-to-lot consistency testing with other methods at an earlier stage. Please click Download on the upper right corner to see the full abstract. |
نوع الوثيقة: | text |
وصف الملف: | application/pdf |
اللغة: | unknown |
Relation: | https://dc.engconfintl.org/vaccine_viii/24; https://dc.engconfintl.org/cgi/viewcontent.cgi?article=1069&context=vaccine_viii |
الاتاحة: | https://dc.engconfintl.org/vaccine_viii/24 https://dc.engconfintl.org/cgi/viewcontent.cgi?article=1069&context=vaccine_viii |
رقم الانضمام: | edsbas.F269A9F1 |
قاعدة البيانات: | BASE |
الوصف غير متاح. |