Biologicals : journal of the International Association of Biological Standardization · 2026
Leveraging analytical and bioprocess platforms for biological product development and commercialization - A meeting report.
Conference ProceedingsНазвание и аннотация: Перевод пока не подготовлен
Обработка статьи · этапы, ошибки и управление
Загрузка состояния…
Ошибки и ограничения
История · было → стало
Состояние обновляется каждые 5 секунд, пока блок открыт. Процент показывается только там, где известен объём работы. Пауза останавливает продолжение этапа; текущий запрос к источнику может завершиться.
Novick Shawn, Bilanin Mihai, Buda Mihaela, Buza Nermin, Frye Christopher Carl, Descamps Frédéric, Dierick Jean-François, Gebrekidan Sy, Gillet Sébastien, Ho Kowid, Hoefnagel Marcel, Jekerle Veronika, Lefebvre Laurent, Mellal Mourad, Moyersoen Juliette, Starkey Jason, Ritter Nadine, Rule Karen, Shapiro Marjorie, Tao Yinying
Аннотация
In May 2025, the International Alliance for Biological Standardization (IABS) held a workshop on analytical and bioprocess platforms for biological product development and commercialization. This workshop explored the use of platform approaches and technologies in product development and registration. The topics discussed included the creation, verification, and maintenance of platform technologies, their lifecycle management, their application in regulatory submissions, and the transition from early clinical trials to commercial approval. The participants highlighted the importance of clearly defining the boundaries and applicability of platform approaches in pharmaceutical development. A consistent and open dialogue between industry stakeholders, regulatory reviewers, and health authorities is essential to ensure a shared understanding and alignment in defining the platform landscape.