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.
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References
ICH Harmonised Tripartite Guideline—Pharmaceutical Development Q8(R2); Step 4 Version August 2009.
Guidance for Industry—Q9 Quality Risk management; United States FDA June 2006 ICH.
Guidance for Industry—Q10 Pharmaceutical Quality System; United States FDA April 2009 ICH.
ICH Harmonised Tripartite Guideline—Development and Manufacture of Drug Substances (Chemical Entities and Biotechnological/Biological Entities) Q11; Step 4 Version 01 May 2012.
Clinical Development Success Rates 2006–2015—BIO, Biomedtracker, Amplion (2016).
Evens RP. Pharma success in product development—does biotechnology change the paradigm in product development and attrition. AAPS J. 2016;18:281–5.
Warne NW. Development of high concentration protein biopharmaceuticals: the use of platform approaches in formulation development. Eur J Pharm Biopharm. 2011;78:208–12.
Rathore AS, Reason AJ, Weiskopf A. Defining critical quality attributes for monoclonal antibody therapeutic products. BioPharm Int. 2014; 27.
Guidance for Industry and FDA Staff: Current Good Manufacturing Practice Requirements for Combination Products—Draft Guidance published January 2015.
Gallo A. A refresher on net present value. Harvard Bus Rev. 2014.
Jorgensen JT. Improvement of patient convenience in treatment with growth hormone. J Pediatr Endocrinol. 1994;7:175–80.
Guidance for Industry and FDA Review Staff: Target Product Profile—A Strategic Development Process Tool—Draft Guidance published March 2007.
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.
Mehta A, Hindmarsh PC. The use of somatropin (recombinant growth hormone) in children of short stature. Pediatr Drugs. 2002;4:37–47.
Goeddel DV, et al. Direct expression in Escherichia coli of a DNA sequence coding for human growth hormone. Nature. 1979;281:544–8.
Product sales for hGH and FVIII products were obtained from annual financial reports and converted to USD using the yearly average exchange rate.
Hemophilia: From Plasma to Recombinant Factors. American Society of Hematology. In: 50 years in hematology: research that revolutionized patient care, www.hematology.org. 2008.
Product histories were obtained from product websites, prescribing information, press releases, the U.S. Food and Drug Administration website, and Pharma Intelligence.
PCSK9 Inhibitors: A Brief Primer. Merle Myerson; Medscape 28 March 2016.
Delivering on the Potential of Biosimilar Medicines; IMS Institute for Healthcare Informatics March 2016.
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Warne, N., Balthazor, B., Parr, W. (2018). Lifecycle Management of Biotherapeutic Dosage Forms. In: Warne, N., Mahler, HC. (eds) Challenges in Protein Product Development. AAPS Advances in the Pharmaceutical Sciences Series, vol 38. Springer, Cham. https://doi.org/10.1007/978-3-319-90603-4_25
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DOI: https://doi.org/10.1007/978-3-319-90603-4_25
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