A new article detailing a round table discussion on quality by design (QbD) authored by leading industry experts including Spinnovation  Biologics CEO Frederic Girard is now available online.

Entitled ‘QbD and PAT in Upstream and Downstream Processing’, the article details the fundamental principles of QbD, how it is used to improve process control, and the impact technological advances have made on QbD biopharmaceutical upstream process optimization. Originally published in the July addition of Biopharm International the full article is now available to read.

The implementation of QbD allows quality assurance to be built into each stage of the development and manufacturing process, ensuring the desired quality of the biological or biopharmaceutical product is guaranteed every time. In the new article Frederic Girard offers his perspectives on QbD, giving industry insight into modern biopharmaceutical process design. Mr Girard shows how critical quality attributes can be assessed in modern biopharmaceutical procedures, using the glycosylation of monoclonal antibodies as an illustration. The article goes on to cover the development of new analytical techniques and methodologies, such as NMR, to reduce performance variability and minimize process failure in large scale biopharmaceutical production.  

Spinnovation Biologics offers a variety of unique solutions to those looking to build QbD into biopharmaceutical manufacture. These include Spedia-Predict^TM, a unique service utilizing a range of Spinnovation’s high-end analytics and chemometric techniques, including Spedia-NMR^TM, NMR fingerprinting, LC-MS profiling and ICP-OES elemental analysis, to assess critical quality attributes and troubleshoot bio-manufacturing performance issues. Methods such as Spedia-NMR^TM allow operators to analyze fermentation media to monitor the uptake of metabolites and nutrients by the cells, providing full visibility of the presence and concentration of feed components, contaminants and metabolites. Spinnovation’s range of analysis services is also available individually, on a contract or pay-per-sample basis.

“Quality by design is becoming an essential aspect of drug manufacture, particularly within biopharmaceuticals”, commented Mr Girard. “However the variability and complexities associated with the upstream biological production makes incorporating QbD a complicated process. Spinnovation Technology provides a unique and specialized service, assessing the critical quality attributes of specific biopharmaceutical manufacturing procedures and finding new and better ways for manufacturers to optimize their process.”

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