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Making individualized drugs a reality

Nature Biotechnology volume 35, pages 507–513 (2017)Cite this article

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An Erratum to this article was published on 01 August 2017

This article has been updated

Magistral drug preparation offers a model to circumvent many of the technological, regulatory and financial challenges that prevent provision of the right drug at the right time to the right patient.

We contend that technological advances now enable both bedside development and magistral drug production as an affordable, safe and flexible alternative for treating patients with individually tailored biopharmaceuticals. As this magistral model is overseen by a physician for individual patients under their care, it is only minimally regulated. This means magistral drugs dispense with the need for protracted marketing authorization, dramatically reducing development times and costs. Here, we outline the challenges inherent in the current model for precision medicine and propose a new model based on the magistral system that can meet the demands of twenty-first century individualized patient care. Although many questions remain unanswered about the pros and cons of bedside drug production, we hope that this Commentary will stimulate vigorous debate and new thinking about this alternative way of making drugs.

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Figure 1: Magistral production in a laminar flow at the Transvaal Pharmacy, a local pharmacy in The Hague, The Netherlands.

Change history

  • 05 June 2017

    In the version of this article initially published, the line “Editor’s note: This article has been peer-reviewed.” was omitted. The error has been corrected in the HTML and PDF versions of the article.

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Authors and Affiliations

  1. Herre Talsma & Enrico Mastrobattista are in the Department of Pharmaceutical Sciences, Huub Schellekens, Faculty of Science, Utrecht University, The Netherlands,

    Huub Schellekens, Herre Talsma & Enrico Mastrobattista

  2. Mohammed Aldosari is in the Department of Pharmaceutical Sciences, Faculty of Science, Utrecht University, The Netherlands, and the Saudi Food and Drug Administration, Riyadh, Saudi Arabia,

    Mohammed Aldosari

Authors
  1. Huub Schellekens
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  2. Mohammed Aldosari
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Correspondence to Huub Schellekens.

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Schellekens, H., Aldosari, M., Talsma, H. et al. Making individualized drugs a reality. Nat Biotechnol 35, 507–513 (2017). https://doi.org/10.1038/nbt.3888

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