Thursday, September 4, 2014

Process Improvements Increase Production Capacity of a Legacy Product

Today, we feature an article from our partners at BioProcess International Magazine. This is an excerpt from the article Process Improvements Increase Production Capacity of a Legacy Product.

Implementation of postlicensure process improvements in the biopharmaceutical industry can benefit patients and drug manufacturers alike. Here we demonstrate through a case study how a change to the cell culture medium and process can be taken from proof of concept through scale-up to demonstration of feasibility. We further illustrate the scope and complexity of implementing a change in commercial manufacturing to realize significant benefits such as increased production capacity over an existing legacy process.

The Importance of Postapproval Improvements
Drug development is a complex process, and related business drivers typically shift through a drug’s life cycle. Before market licensure, the emphasis is on ensuring product safety and efficacy during clinical trials in addition to speed to market (left). The need to lock a process in as soon as possible limits opportunities for optimization. As a consequence, process optimization and capacity improvements are often postlaunch activities performed when the scope of market demand and the competitive business environment are both better understood. After a product is launched, related business drivers shift toward cost of goods (CoGs) and ensuring supply to patients while maintaining product quality. After launch and throughout a commercial production life cycle, process optimization is performed within the strict regulatory and quality frameworks of biopharmaceutical products, of course.

Read the full article here.

You can find out more about topics like this and meet and network with other professionals in the bioprocessing field at this year's BioProcess International Conference and Exhibition.  As a reader of this blog, when you register to join us October 20-23 in Boston, you are eligible to receive 20% off the standard rate when you mention code BPI14BLOG.

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