Aplicación: Respalda la transición del desarrollo de procesos en fase tardía a la fabricación biotecnológica comercial, ayudando a que los productos obtengan la aprobación regulatoria.
País de origen: Austria, Alemania, Suiza
Norma de certificación: Se utiliza para respaldar la documentación de Química, Fabricación y Controles (CMC) y las actividades de presentación regulatoria de productos biológicos.

Otra información

Descripción adicional:

VTU Engineering's Manufacturing Science & Technology group supports development and production teams through the later stages of biotech product development and commercialization, serving as an experienced partner to help products reach approval. The transition from late-phase process development to commercial manufacturing is a pivotal and often complex step toward a successful launch, and the group brings deep experience in process characterization, including risk assessment, study design, design of experiments, and Monte Carlo simulation, alongside technology transfer between labs, sites, or CMOs, and process validation, applying ICH Q8 and Q11 guidelines, Quality by Design principles, and effective risk management and control strategies to bring pipeline products to market promptly.