Cell therapies are an emerging form of healthcare that have started to produce transformative outcomes for patients with previously refractory diseases, but they are substantially more complex than small molecule or biologic drugs and present significant challenges for researchers and companies in cell therapy translation.
SeerPharma and the Cooperative Research Centre (CRC) for Cell Therapy Manufacturing designed and delivered a training course for researchers, clinicians, companies and service providers who needed to understand the regulatory and manufacturing challenges associated with the translation and commercialisation of cell therapies.
Using case studies and examples drawn from industry and consulting experience, participants learnt about:
- the cell therapies industry
- nonclinical guidelines for cell therapy development
- clinical trials – taking a case study from the Royal Adelaide Hospital
- the regulatory pathway for approval of cell therapies
- GMP for cell therapies
Contact us should you wish to learn more about regulations around cell therapy manufacturing and how we may be able to assist your organisation.
To find out more about the activities of the CRC for Cell Therapy Manufacturing, please visit their website at www.ctmcrc.com.
This post comes from our October 2016 Journal. You may also be interested in these posts:
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