Maintaining the quality of vaccines through the use of standards: Current challenges and future opportunities.
Biologicals
; 86: 101756, 2024 May.
Article
en En
| MEDLINE
| ID: mdl-38479213
ABSTRACT
An international hybrid meeting held 21-22 June 2023 in Ottawa, Canada brought together regulators, scientists, and industry experts to discuss a set of principles and best practices in the development and implementation of standards. Although the use of international standards (ISs) and international units (IUs) has been an essential part of ensuring human and animal vaccine quality in the past decades, the types and uses of standards have expanded with technological advances in manufacture and testing of vaccines. The needs of stakeholders are evolving in response to the ever-increasing complexity, diversity, and number of vaccine products as well as increasing efforts to replace animal-based potency tests with in vitro assays that measure relevant quality attributes. As such, there must be a concomitant evolution in the design and implementation of both international and in-house standards. Concomitantly, greater harmonization of regulatory expectations must be achieved through collaboration with standard-setting organizations, national control laboratories and manufacturers. Stakeholders provided perspectives on challenges and several recommendations emerged as essential to advancing agreed upon objectives.
Palabras clave
Texto completo:
1
Bases de datos:
MEDLINE
Asunto principal:
Control de Calidad
/
Vacunas
Límite:
Animals
/
Humans
País/Región como asunto:
America do norte
Idioma:
En
Revista:
Biologicals
Asunto de la revista:
ALERGIA E IMUNOLOGIA
Año:
2024
Tipo del documento:
Article
País de afiliación:
Estados Unidos