Application of industrial biotechnology has changed dramatically over the past decade. Stainless steel process equipment has largely given way to disposable systems, facilitating easier and quicker process configurations and up-scaling. Suppliers generally made incremental advances in the quality of raw materials and consumables to ensure that those could more readily comply, “off the shelf,” with regulatory expectations. Once out-of-reach analytical equipment such as mass spectrometers and cell analyzers are becoming more common place in development laboratories, which better enables biopharmaceutical companies to characterize products and processes and confirm that specifications are being met. Advances in the process and analytical technologies thus have raised the bar of what is possible in-house. Technology transfer continues to play an important role in this modern scenario, whether manufacturing and analytical testing are outsourced or retained and transitioned in-house.
This article provides you with an overview of the latest technology transfer strategies used by biopharmaceutical companies today.
Richard Dennett
March 2015 – BioProcess International
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