U.S. Food and Drug Administration (FDA). MAUDE adverse event report: Novo Nordisk A/S Novopen insulin delivery device 2013. https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfmaude/detail.cfm?mdrfoi__id=3621493. Accessed 09 Feb 2018.
Ben Salem C, Fathallah N, Hmouda H, Bouraoui K. Drug-induced hypoglycaemia. Drug Saf. 2011;34:21–45. https://doi.org/10.2165/11538290-000000000-00000.
McCall AL. Insulin therapy and hypoglycemia. Endocrinol Metab Clin N Am. 2012;41:57–87. https://doi.org/10.1016/j.ecl.2012.03.001.
European Medicines Agency (EMA). Batches of the insulin medicine NovoMix 30 FlexPen and Penfill to be recalled, (EMA/ 657469/ 2013). 2013. http://www.ema.europa.eu/docs/en_GB/document_library/Press_release/2013/10/WC500153147.pdf .Accessed 09 Feb 2018.
Palmer E. Manufacturing glitch leaves novo insulin cartridges with bad fills. 2013.https://www.fiercepharma.com/supply-chain/manufacturing-glitch-leaves-novo-insulin-cartridges-bad-fills. Accessed 08 June 2018.
USP 38-NF 33. Insulin Aspart Injection. Rockville, MD: The United States Pharmacopeial Convention, Inc.; 2015.
Downing NS, Shah ND, Aminawung JA, Pease AM, Zeitoun JD, Krumholz HM, et al. Postmarket safety events among novel therapeutics approved by the US Food and Drug Administration between 2001 and 2010. JAMA. 2017;317:1854–63.
Ebbers HC, NFd T, Hoefnagel MC, Nibbeling R, Mantel-Teeuwisse AK. Characteristics of product recalls of biopharmaceuticals and small-molecule drugs in the USA. Drug Discov Today. 2016;21:536–9. https://doi.org/10.1016/j.drudis.2015.10.020.
U.S. Food and Drug Administration (FDA). Recall (Biologics.https://www.fda.gov/BiologicsBloodVaccines/SafetyAvailability/Recalls/. Accessed 12 Oct 2018.
Yu LX, Kopcha M. The future of pharmaceutical quality and the path to get there. Int J Pharm. 2017;528:354–9. https://doi.org/10.1016/j.ijpharm.2017.06.039.
Junker B, Kosinski M, Geer D, Mahajan R, Chartrain M, Meyer B, et al. Design-for-six-sigma for development of a bioprocess quality-by-design framework. PDA J Pharm Sci Technol. 2011;65:254–86. https://doi.org/10.5731/pdajpst.2011.00739.
Silva Elipe MV, Li L, Nagapudi K, Kook AM, Cobas C, Iglesias I, et al. Application of 19F time-domain NMR to measure content in fluorine-containing drug products. Magn Reson Chem. 2016;54:531–8. https://doi.org/10.1002/mrc.4223.
Corver J, Guthausen G, Kamlowski A. In-line non-contact check-weighing (NCCW) with nuclear magnetic resonance (NMR) presents new opportunities and challenges in process control. Pharm Eng. 2005;25:18–31.
NovoLog® Mix 70/30 (Insulin aspart protamine and insulin aspart injectable suspension) [package insert]. Plainsboro, NJ: NovoNordisk, Inc.; 2001.
Meiboom S, Gill D. Modified spin-echo method for measuring nuclear relaxation times. Rev Sci Instrum. 1958;29:688–91. https://doi.org/10.1063/1.1716296.
Yu YB, Feng Y, Taraban M. Water proton NMR for noninvasive chemical analysis and drug product inspection. Am Pharm Rev. 2017;20:34–8.
Mathonet S, Mahler H, Esswein ST, Mazaheri M, Cash PW, Wuchner K, et al. A biopharmaceutical industry perspective on the control of visible particles in biotechnology derived injectable drug products. PDA J Pharm Sci Technol. 2016;70:392–408. https://doi.org/10.5731/pdajpst.2015.006189.
Briggs KT, Taraban MB, Yu YB. Water proton NMR detection of amide hydrolysis and diglycine dimerization. Chem Commun. 2018;54:7003–6. https://doi.org/10.1039/C8CC03935F.
Popel AS. Hydrodynamics of suspensions. Fluid Dyn. 1969;4:14–18. https://doi.org/10.1007/BF01094677.
Butt H. Controlling the flow of suspensions. Science. 2011;331:868–9. https://doi.org/10.1126/science.1201543.
Shieu W, Lamar D, Stauch OB, Maa Y. Filling of high-concentration monoclonal antibody formulations: investigating underlying mechanisms that affect precision of low-volume fill by peristaltic pump. PDA J Pharm Sci Technol. 2016;70:143–56.
Hanslip S, Desai KG, Palmer M, Bell S, Schofield P, Varma P, et al. Syringe filling of high-concentration mAb formulation: slow suck-back pump speed prevented filling needle clogging. J Pharm Sci. 2017;106:3651–3. https://doi.org/10.1016/j.xphs.2017.08.005.
Hanslip S, Desai KG, Palmer M, Kemp I, Bell S, Schofield P, et al. Syringe filling of a high-concentration mAb formulation: experimental, theoretical, and computational evaluation of filling process parameters that influence the propensity for filling needle clogging. J Pharm Sci. 2019;108:1130–8. https://doi.org/10.1016/j.xphs.2018.10.031.
Ventola CL. The drug shortage crisis in the United States: causes, impact, and management strategies. Pharm Ther. 2011;36:740–57.
Wilson E, Zhu C, Galea S, Marko A, Victoria Urdaneta V, Straus W. Turning up the heat: effect of new vaccine for children’s (VFC) program recommendations for use of temperature monitors upon incorrect product storage adverse event reporting. Vaccine. 2018;36:1516–20. https://doi.org/10.1016/j.vaccine.2017.10.059.
Rosenberg AS, Verthelyi D, Cherney BW. Managing uncertainty: a perspective on risk pertaining to product quality attributes as they bear on immunogenicity of therapeutic proteins. J Pharm Sci. 2012;101:3560–7. https://doi.org/10.1002/jps.23244.