by Brian Salmons, PhD, Oliver Hauser, Walter H. Günzburg, PhD, and Walter Tabotta, DVM
Volume 6, Issue 2 (Summer 2007)
One of the major concerns facing relatively young biotechnology companies once a lead product has been identified is the issue of manufacturing. Usually this involves the upscaling of a lab-scale process while at the same time, complying with good manufacturing practice (GMP) to ensure a reproducibly-produced and consistent product. It also involves the establishment of specific and robust assays in process controls and release criteria. This issue has become more acute in the EU since 2004 due to the EU Clinical Trials Directive requiring GMP-certified production of investigational medical products even for phase I trials. Startup biotech companies are often limited in their finances and resources, as well as being bound by tight milestones. Quite often the expertise in upscaling and GMP-compliant production as well as the facilities and equipment required are not available in-house…
Citation:
Salmons B, Hauser O, Günzburg WH, Tabotta W. GMP Production of an Encapsulated Cell Therapy Product: Issues and Considerations. BioProcess J, 2007; 6(2): 37-44. http://dx.doi.org/10.12665/J62.Salmons