Main opportunities include integrating process validation with modern, science-based approaches, utilizing risk-based strategies like QbD, DOE, and PAT, and adhering to global regulatory standards to ...

Process validation, including process characterization, is a critical step in the successful commercialization of a new biopharmaceutical on its path to commercialization. As the program approaches ...

ValGenesis Smart GxP™ is the first AI-enabled platform purpose-built to unify validation and process development across the product lifecycle. Featuring five integrated applications—ValGenesis iCMC™, ...

In biopharmaceutical manufacturing, consistency is vital but hard to achieve. Turning raw materials into safe, high-quality medicines requires stable processes. However, the living cellular expression ...

Pharmaceutical manufacturing requires defining quality target product profiles and critical quality attributes (CQAs) to ensure desired product quality. Process development identifies critical process ...

SANTA CLARA, Calif., February 27, 2026--(BUSINESS WIRE)--ValGenesis Inc., the global leader in digital validation lifecycle management, will showcase its Process Lifecycle Suite, part of the ...

This article proposes an independent structured review process for legacy products—those pharmaceuticals that predate FDA’s updated process validation and quality by design [QbD] guidance. This ...

Process validation is crucial for ensuring the quality of final products and the safety of these processes for manufacturing personnel and consumers in the pharmaceutical, medical device, and ...

Dublin, June 04, 2025 (GLOBE NEWSWIRE) -- The "Process Validation for Pharmaceutical and Biologics" training has been added to ResearchAndMarkets.com's offering. This FDA Process Validation Training ...

ValGenesis Inc., the global leader in digital validation lifecycle management, will showcase its Process Lifecycle Suite, part of the ValGenesis Smart GxP™ platform, at BioProcessing Summit Europe ...

SANTA CLARA, Calif.--(BUSINESS WIRE)--ValGenesis, Inc., the global innovator in digital validation lifecycle management, today announced the launch of ValGenesis Smart GxP ™, the first AI-enabled ...