03.12.24
ValGenesis Inc., an expert in enterprise validation lifecycle management systems (VLMS), has announced that a Japanese multinational biopharmaceutical company selected ValGenesis iRisk for implementing the ICH Q14 framework on Process Analytical Technology (PAT) analytical methods across its global manufacturing sites.
Already aware of ValGenesis' experience helping customers implement PAT tools, the top 20 biopharmaceuticals company approached ValGenesis to implement a structured framework covering the ICH Q14 guideline on Analytical Method Development, specifically for PAT.
ValGenesis Consulting will:
The company was pleased to have the case for one of their products built within the software, which allows them to showcase the solution to more than a dozen global manufacturing sites.
"We are thrilled to onboard yet another biopharma giant through ValGenesis Consulting, which is at the forefront of several successful technology transfers in the industry today," said Steve Reynolds, Chief Revenue Officer at ValGenesis. "Adopting PAT during commercial production is critical to product safety and quality, enabling large-scale production and process scale-up. With ValGenesis iRisk, our customer is assured of a risk-based Quality by Design (QbD) approach to highly compliant and cost-effective manufacturing."
Already aware of ValGenesis' experience helping customers implement PAT tools, the top 20 biopharmaceuticals company approached ValGenesis to implement a structured framework covering the ICH Q14 guideline on Analytical Method Development, specifically for PAT.
ValGenesis Consulting will:
- Lead the implementation of the ICH Q14 framework via a thorough assessment of the customer's current analytical method development practices across its sites
- Propose a framework for ICH Q14 adoption using ValGenesis iRisk
- Build the case for the customer's product in ValGenesis iRisk
- Train a group of key users within their global MSAT team on the utilization of the framework on ValGenesis iRisk with sandbox access.
The company was pleased to have the case for one of their products built within the software, which allows them to showcase the solution to more than a dozen global manufacturing sites.
"We are thrilled to onboard yet another biopharma giant through ValGenesis Consulting, which is at the forefront of several successful technology transfers in the industry today," said Steve Reynolds, Chief Revenue Officer at ValGenesis. "Adopting PAT during commercial production is critical to product safety and quality, enabling large-scale production and process scale-up. With ValGenesis iRisk, our customer is assured of a risk-based Quality by Design (QbD) approach to highly compliant and cost-effective manufacturing."