Process validation plays a critical role in the success for a new biopharmaceutical on the path of commercialization, including the crucial process characterization. As a program advances towards ...

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™, ...

ValGenesis Inc., the global leader in digital validation lifecycle management, will showcase its AI-enabled Smart GxP™ ...

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 ...

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

ValGenesis, Inc., the market leader in digital validation lifecycle management solutions, announced that a global pharmaceutical and biotechnology leader has successfully expanded its use of the ...

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 ...

European Medicines Agency (EMA) which has been following the US FDA guidelines on Process validation so long, has now revised the process validation norms. The revision incorporates the principles of ...

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 ...

SAN FRANCISCO, Nov. 26, 2019 /PRNewswire/ -- ValGenesis, Inc., a market leader in Validation Lifecycle Management Systems (VLMS), announced today that an Iceland-based biotech firm has selected ...

IBC's 13th International Process Validation for Biopharmaceuticals answers the question: What else can I gain out of my process validation activities and how do I perform them most effectively? In ...

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 ...