Academic Journal

Driving change in dtap batch release testing

التفاصيل البيبلوغرافية
العنوان: Driving change in dtap batch release testing
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