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Technology transfer of novel immunotherapy program: GVAX and CRS-207

Presented at:

IBC’s BioPharmaceutical Development and Production Week; 2014 Mar 24-27; San Diego, CA.

Aduro BioTech is developing novel and complex immunotherapeutics for the treatment of oncology and infectious disease indications. This talk describes a case study for the selection of CMOs and technology transfer for Aduro’s lead clinical immunotherapy, which combines GVAX, a GM-CSF expressing tumor cell line and CRS-207, a live attenuated double deleted Listeria strain, in preparation for pivotal clinical trials. It covers the initial gap assessment process, CMO selection process and how the gap assessment was used to prioritize the technology transfer activities to ensure the knowledge and experience gained during development and early clinical manufacturing is effectively transferred. It concludes with lessons learned from the entire process.