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A Quality by Design Approach to Developing and Manufacturing Polymeric Nanoparticle Drug Products

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  • Theme: Nanotechnology in Complex Drug Products: Learning from the Past, Preparing for the Future
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Abstract

The translation of nanomedicines from concepts to commercial products has not reached its full potential, in part because of the technical and regulatory challenges associated with chemistry, manufacturing, and controls (CMC) development of such complex products. It is critical to take a quality by design (QbD) approach to developing nanomedicines—using a risk-based approach to identifying and classifying product attributes and process parameters and ultimately developing a deep understanding of the products, processes, and platform. This article exemplifies a QbD approach used by BIND Therapeutics, Inc., to industrialize a polymeric targeted nanoparticle drug delivery platform. The focus of the approach is on CMC affairs but consideration is also given to preclinical, clinical, and regulatory aspects of pharmaceutical development. Processes are described for developing a quality target product profile and designing supporting preclinical studies, defining critical quality attributes and process parameters, building a process knowledge map, and employing QbD to support outsourced manufacturing.

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Acknowledgments

We would like to thank Liza Andrianova, Laura Beaudoin, Nicholas Boylan, Jeff Boyle, Lia Brigida, Louise Cadzow, Vicki Campbell, Jessica Cheney, Jagannath Dey, Mike Figa, Allen Horhota, Susan Low, Eric Lewis-Clark, Allison MacRae, Kevin McDonnell, Erick Peeke, Beadle Retnarajan, Abhimanyu Sabnis, Jeffrey Song, Young-Ho Song, Grace Yao, and Jonathan Yingling for the helpful scientific discussion, technical support, and suggestions.

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Authors and Affiliations

  1. Pharmaceutical Development and Operations, BIND Therapeutics, Inc., 325 Vassar Street, Cambridge, Massachusetts, 02139, USA

    Greg Troiano, Jim Nolan, Donald Parsons, Christina Van Geen Hoven & Stephen Zale

Authors
  1. Greg Troiano
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  2. Jim Nolan
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  3. Donald Parsons
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  4. Christina Van Geen Hoven
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  5. Stephen Zale
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Corresponding author

Correspondence to Greg Troiano.

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Guest Editors: Katherine Tyner, Sau (Larry) Lee, and Marc Wolfgang

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Troiano, G., Nolan, J., Parsons, D. et al. A Quality by Design Approach to Developing and Manufacturing Polymeric Nanoparticle Drug Products. AAPS J 18, 1354–1365 (2016). https://doi.org/10.1208/s12248-016-9969-z

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  • DOI: https://doi.org/10.1208/s12248-016-9969-z

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