Abou-El-Enein Mohamed, Bauer Gerhard, Medcalf Nicholas, Volk Hans-Dieter, Reinke Petra
Berlin-Brandenburg Center for Regenerative Therapies, Charité University Medicine, Campus Virchow, Berlin, Germany; Department of Nephrology and Internal Intensive Care, Charité-University Medicine, Campus Virchow, Berlin, Germany.
Institute for Regenerative Cures, University of California Davis, Sacramento, CA, USA.
Cytotherapy. 2016 Aug;18(8):1056-1061. doi: 10.1016/j.jcyt.2016.05.005. Epub 2016 Jun 7.
Cell therapies, especially autologous therapies, pose significant challenges to researchers who wish to move from small, probably academic, methods of manufacture to full commercial scale. There is a dearth of reliable information about the costs of operation, and this makes it difficult to predict with confidence the investment needed to translate the innovations to the clinic, other than as small-scale, clinician-led prescriptions. Here, we provide an example of the results of a cost model that takes into account the fixed and variable costs of manufacture of one such therapy. We also highlight the different factors that influence the product final pricing strategy. Our findings illustrate the need for cooperative and collective action by the research community in pre-competitive research to generate the operational models that are much needed to increase confidence in process development for these advanced products.
细胞疗法，尤其是自体疗法，给那些希望从小规模、可能是学术性的制造方法转向全面商业规模的研究人员带来了重大挑战。关于运营成本的可靠信息匮乏，这使得除了作为小规模、临床医生主导的处方外，很难有信心预测将创新转化为临床应用所需的投资。在此，我们提供一个成本模型结果的示例，该模型考虑了一种此类疗法制造的固定成本和可变成本。我们还强调了影响产品最终定价策略的不同因素。我们的研究结果表明，研究界需要在竞争前研究中采取合作和集体行动，以生成运营模型，这些模型对于提高对这些先进产品工艺开发的信心非常必要。
