Dr Nick Hutchinson from Parker domnick hunter, will be delivering a presentation at BioProduction 2015 about quality by design (QbD) and how it can be integrated into a bioprocess to ensure control over the post approval life cycle management plan.
BioProduction 2015 will take place at City West Hotel Conference and Events Centre in Dublin, Ireland, on October 14-15.
The annual conference showcases technological developments and best practices in biomanufacturing and attracts key biologic manufacturers from across Europe, and the rest of the world.
Dr Nick Hutchinson is the Global Market Development Manager at Parker domnick hunter, a leading supplier of automated bioprocessing solutions incorporating filtration, bioprocess containers, overmolded manifolds and sensor technology.
Dr Hutchinson will be presenting The Application of QbD concepts to a Final Sterile Filtration at BioProduction, which showcases technological developments and explores best practices in bioprocessing.
Quality by design is an approach to defining control strategies for biomanufacturing processes based on sound science and quality risk management.
The methodology emphasizes the importance of understanding a product and its processes to ensure consistent product quality and patient safety is maintained.
The presentation will draw upon leading literature references to describe how to apply QbD to a sterile filtration step during the manufacture of a biopharmaceutical drug product.
An approach to establishing process parameters based on critical quality attributes will be discussed, along with the use of multivariate experiments using scaled down models for process characterization and the generation of design spaces.
The information should help manufacturers integrate their process control strategy into their overall control strategy and ultimately, their post approval life cycle management plan.
Parker domnick hunter - with lead operations in Birtley, UK and Oxnard, California - designs, supplies and delivers whole systems for both upstream and downstream pharmaceutical and biopharmaceutical manufacturing, serving clients predominately in North America and Europe.
It specializes in the development of custom automated processes, incorporating sensor and control technologies, filtration products and single-use consumables.
These single-use solutions help to standardize operations, identify, monitor and control variation and ensure product quality and consistency when upscaling from development to manufacturing scale.
For more information on Parker domnick hunter please visit http://www.parker.com/dhsingleuse