Integrating Phase - Appropriate Quality Standards

Incorporating phase-specific quality standards throughout the development, production, and control processes of biopharmaceuticals ensures compliance with GMP requirements at every stage. This approach facilitates meeting overall development objectives by applying a risk-based framework to address late-stage quality program needs. Additionally, adhering to these standards during technical development promotes thorough and traceable documentation, safeguarding data integrity for regulatory submissions.

Partnering with an experienced Contract Development and Manufacturing Organization (CDMO) can provide valuable expertise in defining expectations and requirements, while efficiently managing accelerated product development timelines.