Lifecycle Management of Biotherapeutic Dosage Forms

  • Nicholas Warne
  • Bryan Balthazor
  • William Parr
Part of the AAPS Advances in the Pharmaceutical Sciences Series book series (AAPS, volume 38)


Lifecycle management of biotherapeutic dosage forms has become an increasingly important strategy for providing patients with enhanced convenience during storage and administration as well as providing companies with an opportunity to compete in an increasingly crowded marketplace. Often, lifecycle management is first considered after a product becomes available for commercial distribution. This approach can cause delays in innovation and result in a loss of opportunity to serve patients and remain competitive. A thoughtful approach to lifecycle management of dosage forms should begin in early product design, providing a framework for continuous improvement and the ability to take advantage of cumulative learning of both the specific compound as well as the therapeutic area and patients’ needs.


Lifecycle management Dosage forms Drug product profile 


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Copyright information

© American Association of Pharmaceutical Scientists 2018

Authors and Affiliations

  • Nicholas Warne
    • 1
  • Bryan Balthazor
    • 2
  • William Parr
    • 3
  1. 1.Biotherapeutic Pharmaceutical Research and Development, Pharmaceutical R&DPfizer Inc.AndoverUSA
  2. 2.BioTherapeutics Pharmaceutical Sciences, Pharmaceutical R&DPfizer Inc.ChesterfieldUSA
  3. 3.Global Marketing, Pfizer Innovative HealthPfizer Inc.CollegevilleUSA

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