This concept paper outlines BioPhorum’s considerations regarding Anvisa’s intention to adopt WHO guidelines while meeting the related ICH ones. The paper demonstrates how national regulatory agencies and biomanufacturers can make use of both guidelines and introduces the desired principles for national regulations.
This paper outlines different applications of modeling to freeze-drying of biopharmaceutical products at commercial scale. It also signals the intent of the BioPhorum collaboration to champion a wider adoption, and realize the full potential of modeling across the industry to standardize lyophilization practices, accelerate technology transfers and optimize operational performance. An Industry Perspective on the Application of Modelling to...
A further two benchmark surveys have been developed by the team. High concentration formulations covers the challenges of high concentrations. You can access this here if you are a member of BioPhorum. For more information on membership, contact Christelle@biophorum.com
The Digital Plant Maturity Model workstream has developed a new version of the Maturity Model. This second version increases consistency by leveling scores across dimensions; simplifies the model by reducing the number of enabling dimensions; and improves its utility by resetting the vision for levels 4 and 5, aligning them with the BioPhorum Technology Roadmap. The team has also developed a Maturity Assessment Tool to be used alongside the...
The BPOG DS reliability workstream has developed guidance enabling member companies to optimize their maintenance and calibration frequencies by assigning the correct ‘trigger’ for these activities.  The guidance describes the various tools and processes available, as well as methods to implement change, illustrated by case studies. The Return on Investment (RoI) for optimization of maintenance frequencies is clear – direct reduction of...