Gaining regulatory and market approval for your stem cell based therapy is merely one of the many challenges facing cell therapy developers. The manufacturing process that follows should not be an afterthought but considered more as an integral component during clinical design and development.
Some important questions need to be answered:
When is the right time to invest in automated manufacture?
What scale up challenges need to be tackled to achieve your commercial target?
It even may be the case that a change in process is required in order to efficiently scale-up the manufacturing process and subsequently reduce costs.
David Smith, Head Therapeutic Cell Solutions, Lonza discusses the clinical scale process bottlenecks and the forward vision for commercialising cell therapies at last year's World Stem Cells & Regenerative Medicine Congress.
For a more in depth overview, view the full presentation here.
You can also see what David Smith will be presenting on at the World Stem Cells & Regenerative Medicine Congress 2012 here. While you're there, why not see who else will be in attendance by looking at the 60+ speaker faculty?