Advertisement

Lifecycle Management of Biotherapeutic Dosage Forms

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

Abstract

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.

Keywords

Lifecycle management Dosage forms Drug product profile 

References

  1. 1.
    ICH Harmonised Tripartite Guideline—Pharmaceutical Development Q8(R2); Step 4 Version August 2009.Google Scholar
  2. 2.
    Guidance for Industry—Q9 Quality Risk management; United States FDA June 2006 ICH.Google Scholar
  3. 3.
    Guidance for Industry—Q10 Pharmaceutical Quality System; United States FDA April 2009 ICH.Google Scholar
  4. 4.
    ICH Harmonised Tripartite Guideline—Development and Manufacture of Drug Substances (Chemical Entities and Biotechnological/Biological Entities) Q11; Step 4 Version 01 May 2012.Google Scholar
  5. 5.
    Clinical Development Success Rates 2006–2015—BIO, Biomedtracker, Amplion (2016).Google Scholar
  6. 6.
    Evens RP. Pharma success in product development—does biotechnology change the paradigm in product development and attrition. AAPS J. 2016;18:281–5.CrossRefPubMedGoogle Scholar
  7. 7.
    Warne NW. Development of high concentration protein biopharmaceuticals: the use of platform approaches in formulation development. Eur J Pharm Biopharm. 2011;78:208–12.CrossRefPubMedGoogle Scholar
  8. 8.
    Rathore AS, Reason AJ, Weiskopf A. Defining critical quality attributes for monoclonal antibody therapeutic products. BioPharm Int. 2014; 27.Google Scholar
  9. 9.
    Guidance for Industry and FDA Staff: Current Good Manufacturing Practice Requirements for Combination Products—Draft Guidance published January 2015.Google Scholar
  10. 10.
    Gallo A. A refresher on net present value. Harvard Bus Rev. 2014.Google Scholar
  11. 11.
    Jorgensen JT. Improvement of patient convenience in treatment with growth hormone. J Pediatr Endocrinol. 1994;7:175–80.CrossRefPubMedGoogle Scholar
  12. 12.
    Guidance for Industry and FDA Review Staff: Target Product Profile—A Strategic Development Process Tool—Draft Guidance published March 2007.Google Scholar
  13. 13.
    Bolge SC, Goren A, Tandon N. Reasons for discontinuation of subcutaneous biologic therapy in the treatment of rheumatoid arthritis: a patient perspective. Patient Prefer Adherence. 2015;9:121–31.CrossRefPubMedPubMedCentralGoogle Scholar
  14. 14.
    Mehta A, Hindmarsh PC. The use of somatropin (recombinant growth hormone) in children of short stature. Pediatr Drugs. 2002;4:37–47.CrossRefGoogle Scholar
  15. 15.
    Goeddel DV, et al. Direct expression in Escherichia coli of a DNA sequence coding for human growth hormone. Nature. 1979;281:544–8.CrossRefPubMedGoogle Scholar
  16. 16.
    Product sales for hGH and FVIII products were obtained from annual financial reports and converted to USD using the yearly average exchange rate.Google Scholar
  17. 17.
    Hemophilia: From Plasma to Recombinant Factors. American Society of Hematology. In: 50 years in hematology: research that revolutionized patient care, www.hematology.org. 2008.
  18. 18.
    Product histories were obtained from product websites, prescribing information, press releases, the U.S. Food and Drug Administration website, and Pharma Intelligence.Google Scholar
  19. 19.
    PCSK9 Inhibitors: A Brief Primer. Merle Myerson; Medscape 28 March 2016.Google Scholar
  20. 20.
    Delivering on the Potential of Biosimilar Medicines; IMS Institute for Healthcare Informatics March 2016.Google Scholar

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

Personalised recommendations