Frederic Girard, CEO of Spinnovation Biologics, has authored a new article detailing the benefits of novel Spedia-NMR™ and NMR technology for Quality by Design (QbD) process development within biologics production.
Entitled ‘Fingerprinting Culture Media’, the article was published in January 2014’s edition of European Biopharmaceutical Review and is now available for download online at http://bit.ly/SPI0059.
The QbD initiative is rapidly being adopted throughout the conventional and bio-pharmaceutical industry to ensure product quality and consistency within manufacture. Exploring the background of the growing QbD movement within biotechnology, Dr. Girard details the ongoing developments within emerging biologic drugs, such as monoclonal antibodies, and offers insight into how implementing modern biopharmaceutical process design is essential for their effective development and manufacture.
The article goes on to detail how Spedia-NMR™ supports this process with straightforward, rapid cell culture analysis - monitoring feed components consumption, metabolites and the accumulation of the desired product - and so enables high levels of understanding and sensitive process control.
“The past decade has seen significant market growth within biologics and bio-similar products”, said Frederic Girard. “However understanding how quality relates to manufacturing procedures is more complicated within biotechnologies due to the sensitivity of biologic processes to slight changes in process parameters. Spent Media Analysis and Raw Material Profiling with NMR have emerged as an effective solution, enabling operators to take full control over the cell culture media being used in their production. With this approach manufacturers can access increased levels of safety, quality and productivity in biologics production and become fully QbD compliant”.