Technology Transfer for Biologics
15 Sep 2014 - 16 Sep 2014 - Cambridge, MA, USA
Once you have established biologic efficacy and safety in early clinical material, your company’s real challenges are only beginning. Replicating the synthesis and bioanalysis of your biologic at different settings and among licensing or manufacturing partners introduces the risk of facility-based errors. And in order to commercialize your biologic, production volumes must be upscaled so intensely that new problems not encountered at smaller clinical volumes may severely hinder your timelines.