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 ...

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

ValGenesis to debut the next generation of VAL™ (ValGenesis AI) at INTERPHEX 2026. Visit booth 3552 for demos and pilot ...

In 2011, FDA’s revised process validation guidance (7) extended ICH’s concepts to pharmaceutical product lifecycle, an approach that is now being applied to cleaning validation and other areas of ...

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 ...

SAN FRANCISCO, July 8, 2020 /PRNewswire/ -- ValGenesis, Inc., a market leader in Enterprise Validation Lifecycle Management solutions, today announced that a fast growing research based ...

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 ...

SAN FRANCISCO--(BUSINESS WIRE)--ValGenesis, Inc., the market leader in enterprise Validation Lifecycle Management Systems (VLMS), has acquired Portugal-based 4Tune Engineering (4TE), a leader in ...

SANTA CLARA, Calif.--(BUSINESS WIRE)--ValGenesis, Inc., the market leader in digital validation lifecycle management solutions, announced that a global pharmaceutical and biotechnology leader has ...

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 ...