Abstract
The use of biomaterials to enable and enhance life-saving therapies in medicine has its documented roots in the 1600s. Historically drugs were administered systemically for acute emergency situations. As injectable drug technologies developed, it was soon observed that drug administration would often be more effective if given in sustained release or tailored release profiles. However, the potential safety risks of drugs administered by these novel devices and biomaterials were also quickly realized. This chapter examines the documented evolution of the delivery of such compounds, the challenges encountered, and the solutions developed to address the need for safe delivery of drugs, proteins, nucleic acids and cells for human use. The advancement of biotechnology has accelerated the need for optimizing the safe and efficacious delivery with new biomaterials and excipients. Each biomaterial-based drug delivery system is unique to the drug, peptide, or protein employed in the system. Therefore, this chapter focuses on the safety considerations along with the therapeutic efficacy offered by this evolving developing area of therapeutics.
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References and Further Reading
Adams D, Gonzalez-Duarte A, O’Riordan WD, Yang C-C, Ueda M, Kristen AV, Tournev I et al (2018) Patisiran, an RNAi therapeutic, for hereditary transthyretin amyloidosis. N Engl J Med 379(1):11–21. https://doi.org/10.1056/NEJMOA1716153
Akinapelli A, Chen JP, Roy K, Donnelly J, Dawkins K, Huibregtse B, Hou D (2017) Current state of bioabsorbable polymer-coated drug-eluting stents. Curr Cardiol Rev 13(2):139. https://doi.org/10.2174/1573403X12666161222155230
Akinc A, Maier MA, Manoharan M, Fitzgerald K, Jayaraman M, Barros S, Ansell S et al (2019) The Onpattro Story and the clinical translation of nanomedicines containing nucleic acid-based drugs. Nat Nanotechnol 14(12):1084–1087. https://doi.org/10.1038/s41565-019-0591-y
Alconcel SNS, Baas AS, Maynard HD (2011) FDA approved poly(ethylene glycol)–protein conjugate drugs. Polym Chem 2(7):1442–1448. https://doi.org/10.1039/C1PY00034A
Alqahtani FY, Aleanizy FS, El Tahir E, Alkahtani HM, AlQuadeib BT (2019) Paclitaxel. In: Profiles of drug substances, excipients and related methodology, vol 44. Academic, pp 205–238. https://doi.org/10.1016/bs.podrm.2018.11.001
Alsugair HA, Alshugair IF, Alharbi TJ, Bin Rsheed AM, Tourkmani AM, Al-Madani W (2021) Weekly Semaglutide vs. Liraglutide efficacy profile: a network meta-analysis. Healthcare (Switzerland), Multidisciplinary Digital Publishing Institute (MDPI). https://doi.org/10.3390/healthcare9091125
Ansell SM, Du X (2019) Lipids and lipid nanoparticle formulations for delivery of nucleic acids. US Patent US10166298B2
Anthony L, Freda PU (2009) From somatostatin to octreotide LAR: evolution of a somatostatin analogue. Curr Med Res Opin 25(12):2989. https://doi.org/10.1185/03007990903328959
Bressler NM, Altaweel M (2006) Changes in retinal neovascularization after Pegaptanib (Macugen) therapy in diabetic individuals. Ophthalmology 113(1):23–28. https://doi.org/10.1016/J.OPHTHA.2005.10.012
Armstrong EJ, Waltenberger J, Rogers JH (2014) Percutaneous coronary intervention in patients with diabetes: current concepts and future directions. J Diabetes Sci Technol 8(3):581–589. https://doi.org/10.1177/1932296813517058
Aryal M, Lau K, Boyer R, Zhou H, Abend J, Karen G, Olbertz J, Gupta S, Zoog S, Larimore K (2021) Achieving efficacy in subjects with sustained Pegvaliase-neutralizing antibody responses. Mol Genet Metab 134(3):235–242. https://doi.org/10.1016/j.ymgme.2021.09.006
Atala A, Bauer SB, Soker S, Yoo JJ, Retik AB (2006) Tissue-engineered autologous bladders for patients needing Cystoplasty. Lancet (London, England) 367(9518):1241–1246. https://doi.org/10.1016/S0140-6736(06)68438-9
Avramis VI, Panosyan EH (2005) Pharmacokinetic/Pharmacodynamic relationships of Asparaginase formulations: the past, the present and recommendations for the future. Clin Pharmacokinet 44(4):367–393. https://doi.org/10.2165/00003088-200544040-00003
Ayouba A, Touré A, Butel C, Keita AK, Binetruy F, Sow MS, Foulongne V et al (2017) Development of a sensitive and specific serological assay based on luminex technology for detection of antibodies to Zaire Ebola virus. J Clin Microbiol 55(1):165–176. https://doi.org/10.1128/JCM.01979-16
Bailey C, Chakravarthy U, Lotery A, Menon G, Talks J (2021) Extended real-world experience with the ILUVIEN® (Fluocinolone Acetonide) implant in the United Kingdom: 3-year results from the Medisoft® Audit Study. Eye 1. https://doi.org/10.1038/S41433-021-01542-W
Banting FG, Best CH (1987) The Journal of Laboratory and Clinical Medicine: Vol. VII St. Louis, February, 1922 No. 5. Nutr Rev 45(4):55–57. https://doi.org/10.1111/J.1753-4887.1987.TB07442.X
Baumann A, Piel I, Hucke F, Sandmann S, Hetzel T, Schwarz T (2019) Pharmacokinetics, excretion, distribution, and metabolism of 60-KDa polyethylene glycol used in BAY 94-9027 in rats and its value for human prediction. Eur J Pharm Sci 130(March):11–20. https://doi.org/10.1016/j.ejps.2019.01.015
van den Bemt BJF, Gettings L, Domańska B, Bruggraber R, Mountian I, Kristensen LE (2019) A portfolio of biologic self-injection devices in rheumatology: how patient involvement in device design can improve treatment experience. Drug Deliv 26(1):384–392. https://doi.org/10.1080/10717544.2019.1587043
Bender C, Maese L, Carter-Febres M, Verma A (2021) Clinical utility of Pegaspargase in children, adolescents and young adult patients with acute lymphoblastic leukemia: a review. Blood Lymphat Cancer Target Ther 11(April):25. https://doi.org/10.2147/BLCTT.S245210
Berg P, Baltimore D, Boyer HW, Cohen SN, Davis RW, Hogness DS, Nathans D et al (1974) Potential biohazards of recombinant DNA molecules [1]. Science 185(4148):303. https://doi.org/10.1126/SCIENCE.185.4148.303/ASSET/0E7197FA-6440-486B-80F7-BBBBC5568C32/ASSETS/SCIENCE.185.4148.303.FP.PNG
Blundell J (1829) Successful case of transfusion. Lancet 1:431–432
Boss AH, Petrucci R, Lorber D (2012) Coverage of prandial insulin requirements by means of an ultra-rapid-acting inhaled insulin. J Diabetes Sci Technol 6(4):773–779. https://doi.org/10.1177/193229681200600406
Bourges JL, Bloquel C, Thomas A, Froussart F, Bochot A, Azan F, Gurny R, BenEzra D, Behar-Cohen F (2006) Intraocular implants for extended drug delivery: therapeutic applications. Adv Drug Deliv Rev 58(11):1182–1202. https://doi.org/10.1016/J.ADDR.2006.07.026
Bressler NM, Altaweel M (2006) Changes in retinal neovascularization after pegaptanib (Macugen) therapy in diabetic individuals. Ophthalmol 113(1):23–28
Brown L, Siemer L, Munoz C, Langer R (1986) Controlled release of insulin from polymer matrices. In vitro kinetics. Diabetes 35(6):684–691. https://doi.org/10.2337/diab.35.6.684
Bunck MC, Diamant M, Cornér A, Eliasson B, Malloy JL, Shaginian RM, Deng W et al (2009) One-year treatment with exenatide improves-cell function, compared with insulin glargine, in metformin-treated type 2 diabetic patients a randomized, controlled trial. https://doi.org/10.2337/dc08-1797
Burger C, Kabir K, Rangger C, Mueller M, Minor T, Tolba RH (2006) Polylactide (LTS) causes less inflammation response than polydioxanone (PDS): A meniscus repair model in sheep. Arch Orthop Trauma Surg 126(10):695–705. https://doi.org/10.1007/S00402-006-0207-5
Butreddy A, Gaddam RP, Kommineni N, Dudhipala N, Voshavar C (2021) PLGA/PLA-based long-acting injectable depot microspheres in clinical use: production and characterization overview for protein/peptide delivery. Int J Mol Sci Multidisciplinary Digital Publishing Institute (MDPI). https://doi.org/10.3390/ijms22168884
Calabresi PA, Kieseier BC, Arnold DL, Balcer LJ, Boyko A, Pelletier J, Liu S et al (2014) Pegylated interferon beta-1a for relapsing-remitting multiple sclerosis (ADVANCE): A randomised, phase 3, double-blind study. Lancet Neurol 13(7):657–665. https://doi.org/10.1016/S1474-4422(14)70068-7
Cao Y, Vacanti J, Paige K, Upton J, Vacanti C (1997) Transplantation of chondrocytes utilizing a polymer-cell construct to produce tissue-engineered cartilage in the shape of a human ear. Plast Reconstr Surg 100(2):297–302
Casadevall N, Nataf J, Viron B, Kolta A, Kiladjian J-J et al (2002) Pure Red-Cell aplasia and antierythropoietin antibodies in patients treated with recombinant erythropoietin. N Eng J Med 346(7):469–475. https://doi.org/10.1056/NEJMoa011931
Center for Drug Evaluation and Research. 2005. “Abraxane FDA approval”
Choonara YE, Pillay V, Danckwerts MP, Carmichael TR, Du Toit LC (2010) A review of implantable intravitreal drug delivery technologies for the treatment of posterior segment eye diseases. J Pharm Sci 99(5):2219–2239. https://doi.org/10.1002/JPS.21987
Cms.gov (2021) Article – self-administered drug exclusion list: (A52571). 2021. https://www.cms.gov/medicare-coverage-database/view/article.aspx?articleId=52571&DocID=A52571
“Code of Federal Regulations.” (2021) Title 21/ChapterI/Subchapter A/Part 3/Subpart A/§3.2. 2021. https://www.ecfr.gov/current/title-21/chapter-I/subchapter-A/part-3/subpart-A/section-3.2
Dailey G, Rosenstock J, Moses RG, Ways K (2004) Insulin glulisine provides improved glycemic control in patients with type 2 diabetes. Diabetes Care 27(10):2363–2368. https://doi.org/10.2337/DIACARE.27.10.2363
Davis A, Kuriakose J, Clements JN (2019) Faster insulin aspart: a new bolus option for diabetes mellitus. Clin Pharmacokinet 58(4):421–430. https://doi.org/10.1007/S40262-018-0696-8
Defelippis MR, Bakaysa DL, Bell MA, Heady MA, Li S, Pye S, Youngman KM, Radziuk J, Frank BH (1998) Preparation and characterization of a cocrystalline suspension of [LysB28,ProB29]-Human insulin analogue. J Pharm Sci 87(2):170–176. https://doi.org/10.1021/JS970285M
Dhillon B, Kamal A, Leen C (1998) Intravitreal sustained-release ganciclovir implantation to control cytomegalovirus retinitis in AIDS. Int J STD AIDS 9(4):227–230. https://doi.org/10.1258/0956462981922098
Dozier JK, Distefano MD (2015) Site-specific pegylation of therapeutic proteins. Int J Mol Sci 16(10):25831–25864. https://doi.org/10.3390/ijms161025831
Drugs Development & Approval Process (2021) Advancing health through innovation new drug therapy approvals 2020. U.S. Food and Drug Administration (FDA), no. January: 1–44. www.fda.gov
Duckworth WC, Bennett RG, Hamel FG (1998) Insulin degradation: progress and potential. Endocr Rev 19(5):608–624. https://doi.org/10.1210/EDRV.19.5.0349
Dunn AL, Ahuja SP, Mullins ES (2018) Real-world experience with use of Antihemophilic factor (recombinant), PEGylated for prophylaxis in severe Haemophilia A. Haemophilia 24(3):e84–e92. https://doi.org/10.1111/hae.13403
Ellis-Behnke RG, Liang YX, You SW, Tay DKC, Zhang S, So KF, Schneider GE (2006) Nano neuro knitting: peptide nanofiber scaffold for brain repair and axon regeneration with functional return of vision. Proc Natl Acad Sci U S A 103(13):5054–5059. https://doi.org/10.1073/PNAS.0600559103
Erichsen JE (1874) Hospitalism and the causes of death after operations and surgical injuries. Longmans, Green, London
Eugster EA, Clarke W, Kletter GB, Lee PA, Kirk Neely E, Reiter EO, Saenger P et al (2007) Efficacy and safety of Histrelin subdermal implant in children with central precocious puberty: A multicenter trial. J Clin Endocrinol Metabol 92(5):1697–1704. https://doi.org/10.1210/JC.2006-2479
Ezban M, Hansen M, Kjalke M (2020) An overview of Turoctocog Alfa Pegol (N8-GP; ESPEROCT®) assay performance: implications for postadministration monitoring. Haemophilia 26(1):156–163. https://doi.org/10.1111/hae.13897
Ezban M, Hermit MB, Persson E (2019) FIXing postinfusion monitoring: assay experiences with N9-GP (Nonacog Beta Pegol; Refixia ® ; Rebinyn ® ). Haemophilia 25(1):154–161. https://doi.org/10.1111/hae.13671
FDA.gov (2021) FDA Approves Sirolimus protein-bound particles for malignant perivascular epithelioid cell tumore. 2021. https://www.fda.gov/drugs/resources-information-approved-drugs/fda-approves-sirolimus-protein-bound-particles-malignant-perivascular-epithelioid-cell-tumor
FDA (2005) Asparlas – FDA Prescribing Information, side effects and uses. 2005. https://www.drugs.com/pro/asparlas.html
“FDA Approved PEGylated Drugs Up To 2021 | Biopharma PEG.” (n.d.) Accessed 2 January 2022. https://www.biochempeg.com/article/58.html
FDA, and CDER (2018) FDA FY18 GDUFA science and research report FY2018 GDUFA science and research report: long-acting injectables and implants. 2018. https://www.fda.gov/ForIndustry/UserFees/GenericDrugUserFees/ucm549166.htm
FDA Center for Devices and Radiological Health (2010) Non-Clinical engineering tests and recommended labeling for intravascular stents and associated delivery systems – guidance for industry and FDA Staff | FDA. 2010. https://www.fda.gov/regulatory-information/search-fda-guidance-documents/non-clinical-engineering-tests-and-recommended-labeling-intravascular-stents-and-associated-delivery
Fire A, Xu S, Montgomery MK, Kostas SA, Driver SE, Mello CC (1998) Potent and specific genetic interference by double-stranded RNA in Caenorhabditis elegans. Nature 391(6669):806–811. https://doi.org/10.1038/35888
Fishbane S, Roger SD, Martin E, Runyan G, O’Neil J, Qiu P, Locatelli F (2013) Peginesatide for maintenance treatment of anemia in hemodialysis and nondialysis patients previously treated with Darbepoetin alfa. Clin J Am Soc Nephrol 8(4):538–545. https://doi.org/10.2215/CJN.03440412
Freda P, Gordon M, Kelepouris N, Jonsson P, Koltowska-Haggstrom M, Van Der Lely A (2015) Long-term treatment with Pegvisomant as monotherapy in patients with acromegaly: experience from Acrostudy. Endocr Pract 21(3):264–274. https://doi.org/10.4158/EP14330.OR
Fry DW, Richardson KE (1979) Isolation and characterization of glycolic acid dehydrogenase from human liver. Biochim Biophys Acta 567(2):482–491. https://doi.org/10.1016/0005-2744(79)90134-7
Fung AE, Lalwani GA, Rosenfeld PJ, Dubovy SR, Michels S, Feuer WJ, Puliafito CA, Davis JL, Flynn HW, Esquiabro M (2007) An optical coherence tomography-guided, variable dosing regimen with intravitreal Ranibizumab (Lucentis) for Neovascular age-related macular degeneration. Am J Ophthalmol 143(4). https://doi.org/10.1016/J.AJO.2007.01.028
Garnock-Jones KP, Plosker GL (2012) Insulin glulisine. Drugs 2009 69(8):1035–1057. https://doi.org/10.2165/00003495-200969080-00006
Gelderblom H, Verweij J, Nooter K, Sparreboom A (2001) Cremophor EL: the drawbacks and advantages of vehicle selection for drug formulation. Eur J Cancer (Oxford, England: 1990) 37(13):1590–1598. https://doi.org/10.1016/S0959-8049(01)00171-X
Genentech Inc. (1999) Nutropin Depot®: somatropin (rDNA origin) for injectable suspension, South San Francisco, CA
Genentech Inc. (2002) Nutropin Depot®: somatropin (rDNA origin) for injectable suspension, South San Francisco, CA
Gillies PS, Figgitt DP, Lamb HM (2000) Insulin glargine. Drugs 59(2):253–260. https://doi.org/10.2165/00003495-200059020-00009
Goel N, Stephens S (2010) Certolizumab Pegol. MAbs 2(2):137–147. https://doi.org/10.4161/mabs.2.2.11271
Gough SCL, Harris S, Woo V, Davies M (2013) Insulin Degludec: overview of a novel ultra long-acting basal insulin. Diabetes Obes Metab 15(4):301–309. https://doi.org/10.1111/DOM.12052
Grosman B, Di W, Parikh N, Roy A, Voskanyan G, Kurtz N, Sturis J, Cohen O, Ekelund M, Vigersky R (eds) (2021) Fast-acting insulin aspart (Fiasp®) improves glycemic outcomes when used with MiniMedTM 670G hybrid closed-loop system in simulated trials compared to NovoLog®. Computer Methods and Programs in Biomedicine 205. https://doi.org/10.1016/j.cmpb.2021.106087
Hagedorn HC, Norman Jensen B, Krarup NB, Wodstrup I (1936) Protamine INSULINATE. J Am Med Assoc 106(3):177. https://doi.org/10.1001/jama.1936.02770030007002
Hallas Møller K, Jersild M, Petersen K, Schlichtkrull J (1952) Zinc insulin preparations for single daily injection; clinical studies of new preparations with prolonged action. J Am Med Assoc 150(17):1667–1671. https://doi.org/10.1001/JAMA.1952.03680170021006
Hammond SM, Aartsma-Rus A, Alves S, Borgos SE, Buijsen RAM, Collin RWJ, Covello G et al (2021) Delivery of oligonucleotide-based therapeutics: challenges and opportunities. EMBO Mol Med 13(4):10.15252/EMMM.202013243
Heathcote EJ, Shiffman ML, Graham W, Cooksley E, Dusheiko GM, Lee SS, Balart L, Reindollar R et al (2000) Peginterferon alfa-2a in patients with chronic hepatitis C and cirrhosis. N Engl J Med 343(23):1673–1680. https://doi.org/10.1056/NEJM200012073432302
Heise T, Linnebjerg H, Coutant D, LaBell E, Zijlstra E, Kapitza C, Bue-Valleskey J, Zhang Q, Dellva MA, Leohr J (2020) Ultra rapid Lispro lowers postprandial glucose and more closely matches Normal physiological glucose response compared to other rapid insulin analogues: a phase 1 randomized, crossover study. Diabetes Obes Metab 22(10):1789–1798. https://doi.org/10.1111/DOM.14094
Heo YA, Syed YY, Keam SJ (2019) Pegaspargase: A review in acute lymphoblastic Leukaemia. Drugs 79(7):767–777. https://doi.org/10.1007/S40265-019-01120-1
Hillmen P, Szer J, Weitz I, Röth A, Höchsmann B, Panse J, Usuki K et al (2021) Pegcetacoplan versus Eculizumab in paroxysmal nocturnal hemoglobinuria. N Engl J Med 384(11):1028–1037. https://doi.org/10.1056/NEJMOA2029073
Hirsch IB, Juneja R, Beals JM, Antalis CJ, Wright EE (2020) The evolution of insulin and how it informs therapy and treatment choices. Endocr Rev 41(5):733–755. https://doi.org/10.1210/ENDREV/BNAA015
Home PD, Barriocanal L, Lindholm A (1999) Comparative pharmacokinetics and pharmacodynamics of the novel rapid-acting insulin analogue, insulin aspart, in healthy volunteers. Eur J Clin Pharmacol 55(3):199–203. https://doi.org/10.1007/S002280050618
Honor A, Rudnick SR, Bonkovsky HL (2021) Givosiran to treat acute porphyria. Drugs Today (Barc) 57(1):47–59. https://doi.org/10.1358/DOT.2021.57.1.3230207
Hou X, Zaks T, Langer R, Dong Y (2021) Lipid nanoparticles for MRNA delivery. Nat Rev Mat 1. https://doi.org/10.1038/s41578-021-00358-0
Hou Y, Lu H (2019) Protein PEPylation: a new paradigm of protein-polymer conjugation. Bioconjug Chem 30(6):1604–1616. https://doi.org/10.1021/acs.bioconjchem.9b00236
Hoy SM (2019) LA-EP2006: a Pegfilgrastim biosimilar. BioDrugs 33(2):229–232. https://doi.org/10.1007/s40259-019-00348-3
Hoy S (2021) Pegcetacoplan: first approval. Drugs. https://doi.org/10.1007/s40265-021-01560-8
Huang CE, Wu YY, Hsu CC, Chen YJ, Tsou HY, Li CP, Lai YH, Lu CH, Chen PT, Chen CC (2021) Real-world experience with Ropeginterferon-alpha 2b (Besremi) in Philadelphia-negative myeloproliferative neoplasms. J Formos Med Assoc = Taiwan Yi Zhi 120(2):863–873. https://doi.org/10.1016/J.JFMA.2020.08.021
Human Insulin Receives FDA Approval (1982) FDA Drug Bull 12
Hwang CW, David W, Edelman ER (2001) Physiological transport forces govern drug distribution for stent-based delivery. Circulation 104(5):600–605. https://doi.org/10.1161/HC3101.092214
Hydery T, Coppenrath VA (2019) A comprehensive review of Pegvaliase, an enzyme substitution therapy for the treatment of phenylketonuria. Drug Target Insights. AboutScience. https://doi.org/10.1177/1177392819857089
Ibach MJ, Shafer BM, Wallin DD, Puls-Boever KR, Thompson VM, Berdahl JP (2021) The effectiveness and safety of Dextenza 0.4 Mg for the treatment of postoperative inflammation and pain in patients after photorefractive keratectomy: the RESTORE trial. J Refract Surg (Thorofare, N.J.: 1995) 37(9):590–594. https://doi.org/10.3928/1081597X-20210610-05
ISO (2010) 10993–13 Identification and quantification of degradation products from polymeric medical devices
ISO (2018) ISO – 11.100.20 – biological evaluation of medical devices. International Organization for Standardization. 2018. https://www.iso.org/ics/11.100.20/x/
Dippenaar JM (2007) Local anaesthetic toxicity. SAJAA 13(3):23–28
Johannsson G, Feldt-Rasmussen U, Håkonsson IH, Biering H, Rodien P, Tahara S, Toogood A, Rasmussen MH (2018) Safety and convenience of once-weekly Somapacitan in adult GH deficiency: a 26-week randomized, controlled trial. Eur J Endocrinol 178(5):491–499. https://doi.org/10.1530/EJE-17-1073
Kapoor KG, Wagner MG, Wagner AL (2015) The sustained-release dexamethasone implant: expanding indications in vitreoretinal disease. Semin Ophthalmol 30(5–6):475–481. https://doi.org/10.3109/08820538.2014.889179
Karikó K, Muramatsu H, Welsh FA, Ludwig J, Kato H, Akira S, Weissman D (2008) Incorporation of pseudouridine into MRNA yields superior nonimmunogenic vector with increased translational capacity and biological stability. Mol Ther 16(11):1833–1840. https://doi.org/10.1038/mt.2008.200
Keating GM (2009) Peginterferon-alpha-2a (40 KD): a review of its use in chronic hepatitis B. Drugs 69(18):2633–2660. https://doi.org/10.2165/11203660-000000000-00000
Kessler M, Goldsmith D, Schellekens H (2006) Immunogenicity of biopharmaceuticals. Nephrol Dial Transplant 21(Suppl 5). https://doi.org/10.1093/NDT/GFL476
Khehra N, Padda I, Jaferi U, Atwal H, Narain S, Parmar MS (2021) Tozinameran (BNT162b2) vaccine: the journey from preclinical research to clinical trials and authorization. AAPS PharmSciTech 22. https://doi.org/10.1208/s12249-021-02058-y
Kieseier BC, Arnold DL, Balcer LJ, Boyko AA, Pelletier J, Liu S, Zhu Y et al (2015) Peginterferon beta-1a in multiple sclerosis: 2-year results from ADVANCE. Mult Scler 21(8):1025–1035. https://doi.org/10.1177/1352458514557986
Kim J, Eygeris Y, Gupta M, Sahay G (2021) Self-assembled MRNA vaccines. Adv Drug Deliv Rev 170(March):83–112. https://doi.org/10.1016/J.ADDR.2020.12.014
Kinoshita H, Kawa G, Hiura Y, Chizaki R, Matsuda T (2010) Effectiveness of skin icing in reducing pain associated with Goserelin acetate injection. Int J Clin Oncol 15(5):472–475. https://doi.org/10.1007/S10147-010-0095-0
Knobil E (1990) The GnRH pulse generator. Am J Obstet Gynecol 163(5):1721–1727. https://doi.org/10.1016/0002-9378(90)91435-F
Kozlowski A, Milton Harris J (2001) Improvements in protein PEGylation: pegylated interferons for treatment of hepatitis C. J Control Release 72(1–3):217–224. https://doi.org/10.1016/S0168-3659(01)00277-2
Kuan JW, Su AT, Leong CF (2017) Pegylated granulocyte-Colony stimulating factor versus non-Pegylated granulocyte-Colony stimulating factor for peripheral blood stem cell mobilization: A systematic review and meta-analysis. J Clin Apher 32(6):517–542. https://doi.org/10.1002/jca.21550
Lah M, McPheron M (2021) Palynziq clinic: one year and 43 patients later. Mol Genet Metab 133(3):250–256. https://doi.org/10.1016/j.ymgme.2021.05.006
Lancranjan I, Bruns C, Grass P, Jaquet P, Jervell J, Kendall-Taylor P, Lamberts SWJ et al (1995) Sandostatin LAR®: pharmacokinetics, pharmacodynamics, efficacy, and tolerability in acromegalic patients. Metabolism 44(SUPPL. 1):18–26. https://doi.org/10.1016/0026-0495(95)90306-2
Landsteiner K (1900) Zur Kenntnis Der Antifermentativen, Lytischen Und Agglutinierenden Wirkung Des Blutserums Und Der Lymphe. Parasitenkunde Und Infektionskrankheiten 27:357–362. https://www.abebooks.com/Kenntnis-antifermentativen-lytischen-agglutinierenden-Wirkung-Blutserums/22453245225/bd
Lau J, Bloch P, Schäffer L, Pettersson I, Spetzler J, Kofoed J, Madsen K et al (2015) Discovery of the once-weekly glucagon-like peptide-1 (GLP-1) analogue Semaglutide. J Med Chem 58(18):7370–7380. https://doi.org/10.1021/acs.jmedchem.5b00726
Leacock JH (1817) On transfusion of blood in extreme cases of haemorrhage. Med Chir J Rev 3:276–284
Learoyd P (2012) The history of blood transfusion prior to the 20th century – part 1. Transfus Med (Oxford, England) 22(5):308–314. https://doi.org/10.1111/J.1365-3148.2012.01180.X
Lewis AL, McEntee N, Holland J, Patel A (2021) Development and approval of Rybelsus (Oral Semaglutide): ushering in a new era in peptide delivery. Drug Deliv Transl Res 12(1):1–6. https://doi.org/10.1007/s13346-021-01000-w
Lister J (1867) On the antiseptic principle in the practice of surgery. Br Med J 2(351):246. https://doi.org/10.1136/BMJ.2.351.246
Lower R (1932) Tractatus de Corde Item de Motu et Colore Sanguinis. Kessinger Publishing, LLC. https://www.amazon.com/Tractatus-Corde-Colore-Sanguinis-Latin/dp/1166305708
Luzio SD, Beck P, Owens DR (2003) Comparison of the subcutaneous absorption of insulin glargine (Lantus) and NPH insulin in patients with type 2 diabetes. Horm Metab Res = Hormon- Und Stoffwechselforschung = Hormones et Metabolisme 35(7):434–438. https://doi.org/10.1055/S-2003-41625
Lv H, Zhang S, Wang B, Cui S, Yan J (2006) Toxicity of cationic lipids and cationic polymers in gene delivery. J Control Release 114(1):100–109. https://doi.org/10.1016/J.JCONREL.2006.04.014
Ma X, Tim W, Robich MP (2012) Drug-eluting stent coatings. Interv Cardiol 4(1):73–83. https://doi.org/10.2217/ICA.11.88
Macdougall IC, Eckardt KU (2006) Novel strategies for stimulating erythropoiesis and potential new treatments for anaemia. Lancet 368(9539):947–953. https://doi.org/10.1016/S0140-6736(06)69120-4
Macdougall IC, Padhi D, Jang G (2007) Pharmacology of Darbepoetin alfa. Nephrol Dial Transplant 22(Suppl):4. https://doi.org/10.1093/NDT/GFM160
Mansour D (2010) Nexplanon®: what Implanon® Did Next. J Fam Plann Reprod Health Care 36(4):187–189. https://doi.org/10.1783/147118910793048629
McGuire WP, Rowinsky EK, Rosenhein NB, Grumbine FC, Ettinger DS, Armstrong DK, Donehower RC (1989) Taxol: a unique antineoplastic agent with significant activity in advanced ovarian epithelial neoplasms. Ann Intern Med 111(4):273–279. https://doi.org/10.7326/0003-4819-111-4-273
Meade KR, Silver FH (1990) Immunogenicity of collagenous implants. Biomaterials 11(3):176–180. https://doi.org/10.1016/0142-9612(90)90151-F
Metzner HJ, Weimer T, Kronthaler U, Lang W, Schulte S (2009) Genetic fusion to albumin improves the pharmacokinetic properties of factor IX. Thromb Haemost 102(4):634–644. https://doi.org/10.1160/TH09-04-0255
Miele E, Spinelli GP, Miele E, Tomao F, Tomao S (2009) Albumin-bound formulation of paclitaxel (Abraxane® ABI-007) in the treatment of breast cancer. Int J Nanomedicine 4(1):99. https://doi.org/10.2147/IJN.S3061
Mikhail A (2012) Profile of Peginesatide and its potential for the treatment of anemia in adults with chronic kidney disease who are on dialysis. J Blood Med 3(May):25–31. https://doi.org/10.2147/jbm.s23270
Miller BS, Velazquez E, Yuen KCJ (2020) Long-acting growth hormone preparations – current status and future considerations. J Clin Endocrinol Metab 105(6):e2121. https://doi.org/10.1210/CLINEM/DGZ149
Mima Y, Hashimoto Y, Shimizu T, Kiwada H, Ishida T (2015) Anti-PEG IgM is a major contributor to the accelerated blood clearance of polyethylene glycol-conjugated protein. Mol Pharm 12(7):2429–2435. https://doi.org/10.1021/acs.molpharmaceut.5b00144
Morfini M (2016) Pharmacokinetic drug evaluation of Albutrepenonacog Alfa (CSL654) for the treatment of hemophilia. 12(11):1359–1365. https://doi.org/10.1080/17425255.2016.1240168
Morice MC, Serruys PW, Barragan P, Bode C, Van Es GA, Stoll HP, Snead D, Mauri L, Cutlip DE, Sousa E (2007) Long-term clinical outcomes with Sirolimus-eluting coronary stents: five-year results of the RAVEL trial. J Am Coll Cardiol 50(14):1299–1304. https://doi.org/10.1016/J.JACC.2007.06.029
Morrow JF, Cohen SN, Chang ACY, Boyer HW, Goodman HM, Helling RB (1974) Replication and transcription of eukaryotic DNA in Escherichia Coli. Proc Natl Acad Sci U S A 71(5):1743–1747. https://doi.org/10.1073/PNAS.71.5.1743
Murguia-Favela L, Min W, Loves R, Leon-Ponte M, Grunebaum E (2020) Comparison of Elapegademase and Pegademase in ADA-deficient patients and mice. Clin Exp Immunol 200(2):176–184. https://doi.org/10.1111/cei.13420
Navarese EP et al (2013) Safety and efficacy outcomes of first and second generation durable polymer drug eluting stents and biodegradable polymer biolimus eluting stents in clinical practice: Comprehensive network meta-analysis. BMJ 347
Nyborg AC, Ward C, Zacco A, Chacko B, Grinberg L, Geoghegan JC, Bean R et al (2016) A therapeutic uricase with reduced immunogenicity risk and improved development properties. PLoS One 11(12):e0167935. https://doi.org/10.1371/journal.pone.0167935
Okada H (1997) One- and three-month release injectable microspheres of the LH-RH superagonist leuprorelin acetate. Adv Drug Deliv Rev. https://doi.org/10.1016/S0169-409X(97)00050-1
Overbay DK, Manley HJ (2002) Darbepoetin-alpha: a review of the literature. Pharmacotherapy 22(7):889–897. https://doi.org/10.1592/PHCO.22.11.889.33633
Paik J, Deeks ED (2019) Damoctocog alfa Pegol: a review in Haemophilia A. Drugs 79(10):1147–1156. https://doi.org/10.1007/s40265-019-01152-7
Pardi N, Hogan MJ, Porter FW, Weissman D (2018) MRNA vaccines – a new era in vaccinology. Nat Rev Drug Discov 17(4):261. https://doi.org/10.1038/NRD.2017.243
Patel JN, Walko CM (2012) Sylatron: Une Formulation Pégylée d’interféron Pour Le Traitement Du Mélanome. Ann Pharmacother 46(6):830–838. https://doi.org/10.1345/aph.1Q791
Pettitt DJ, Ospina P, Howard C, Zisser H, Jovanovic L (2007) Efficacy, safety and lack of immunogenicity of insulin aspart compared with regular human insulin for women with gestational diabetes mellitus. Diabet Med 24(10):1129. https://doi.org/10.1111/J.1464-5491.2007.02247.X
Philips JC, Scheen A (2006) Insulin Detemir in the treatment of type 1 and type 2 diabetes. Vasc Health Risk Manag 2(3):277–283. https://doi.org/10.2147/vhrm.2006.2.3.277
Pons-Faudoa FP, Ballerini A, Sakamoto J, Grattoni A (2019) Advanced implantable drug delivery technologies: transforming the clinical landscape of therapeutics for chronic diseases. Biomed Microdevices 21(2):47. https://doi.org/10.1007/s10544-019-0389-6
Pradhananga S, Wilkinson I, Ross RJM (2002) Pegvisomant: structure and function. J Mol Endocrinol 29(1):11–14. https://doi.org/10.1677/jme.0.0290011
Recordati Rare Diseases Inc., Lebanon, NJ 08833 U.S.A. (2012) SIGNIFOR® LAR (Pasireotide) for injectable suspension, for intramuscular use. U.S. Food and Drug Administration. www.fda.gov/medwatch
Rendell M (2014) Technosphere inhaled insulin (Afrezza). Drugs Today (Barc) 50(12):813–827. https://doi.org/10.1358/DOT.2014.50.12.2233894
Rizas KD, Mehilli J (2016) Stent polymers: do they make a difference? Circ Cardiovasc Interv 9(6). https://doi.org/10.1161/CIRCINTERVENTIONS.115.002943
Ruffell D (2021) The future in an RNA molecule: from MRNA vaccines to therapeutics – an interview with Drew Weissman. FEBS Lett 595(18):2305. https://doi.org/10.1002/1873-3468.14190
Rynd F (1845) Neuralgia – introduction of fluid to the nerve. Dublin Med Press 13:167–168
Sánchez-Trasviña C, Flores-Gatica M, Enriquez-Ochoa D, Rito-Palomares M, Mayolo-Deloisa K (2021) Purification of modified therapeutic proteins available on the market: an analysis of chromatography-based strategies. Front Bioeng Biotechnol 9. https://doi.org/10.3389/fbioe.2021.717326
Sarala N, Bengalorkar G, Bhuvana K (2012) Technosphere insulin: a new inhaled insulin. Practical Diabetes 29(1):23–25. https://doi.org/10.1002/PDI.1651
Scarpignato C, Pelosini I (2001) Somatostatin analogs for cancer treatment and diagnosis: an overview. Chemotherapy. https://doi.org/10.1159/000049157
Schmidt PJ, Leacock AG (2002) Forgotten transfusion history: John Leacock of Barbados. Br Med J 325(7378):1485–1487. https://doi.org/10.1136/bmj.325.7378.1485
Schoenmaker L, Witzigmann D, Kulkarni JA, Verbeke R, Kersten G, Jiskoot W, Crommelin DJA (2021) MRNA-lipid nanoparticle COVID-19 vaccines: structure and stability. Int J Pharm 601(May):120586. https://doi.org/10.1016/j.ijpharm.2021.120586
Schorr MR (1966) Needles. Some points to think about. Anesth Analg 45(4):509–513. https://pubmed.ncbi.nlm.nih.gov/5330041/
Schreiber I, Buchfelder M, Droste M, Forssmann K, Mann K, Saller B, Strasburger CJ (2007) Treatment of acromegaly with the GH receptor antagonist pegvisomant in clinical practice: safety and efficacy evaluation from the German Pegvisomant Observational Study. Eur J Endocrinol 156(1):75–82. https://doi.org/10.1530/eje.1.02312
Selby C, Peyton-Thomas B, Eslami P (2021) Pegfilgrastim biosimilars: where are we now? J Adv Pract Oncol 12(5):541. https://doi.org/10.6004/jadpro.2021.12.5.9
Setji TL, Hong BD, Feinglos MN (2016) Technosphere insulin: inhaled prandial insulin. Expert Opin Biol Ther 16(1):111–117. https://doi.org/10.1517/14712598.2016.1121230
Shore N, Cookson MS, Gittelman MC (2012) Long-term efficacy and tolerability of once-yearly Histrelin acetate subcutaneous implant in patients with advanced prostate cancer. BJU Int 109(2):226–232. https://doi.org/10.1111/J.1464-410X.2011.10370.X
Siegel JD, Rhinehart E, Jackson M, Chiarello L (2009) Guideline for isolation precautions: preventing transmission of infectious agents in healthcare settings 2007. Hospital-Acquired Infect 1–232. http://www.cdc.gov/ncidod/dhqp/pdf/isolation2007.pdf
Sigwart U, Puel J, Mirkovitch V, Joffre F, Kappenberger L (1987) Intravascular stents to prevent occlusion and re-stenosis after transluminal angioplasty. N Engl J Med 316(12):701–706. https://doi.org/10.1056/nejm198703193161201
Strohl WR (2015) Fusion proteins for half-life extension of biologics as a strategy to make biobetters. BioDrugs 29(4):215–239. https://doi.org/10.1007/s40259-015-0133-6
Svitkin YV, Cheng YM, Chakraborty T, Presnyak V, John M, Sonenberg N (2017) N1-methyl-pseudouridine in MRNA enhances translation through EIF2α-dependent and independent mechanisms by increasing ribosome density. Nucleic Acids Res 45(10):6023. https://doi.org/10.1093/NAR/GKX135
Tanni KA, Truong CB, Almahasis S, Qian J (2021) Safety of marketed cancer supportive care biosimilars in the US: A disproportionality analysis using the Food and Drug Administration Adverse Event Reporting System (FAERS) database. BioDrugs 35(2):239–254. https://doi.org/10.1007/s40259-020-00466-3
Thi TTH, Suys EJA, Lee JS, Nguyen DH, Park KD, Truong NP (2021) Lipid-based nanoparticles in the clinic and clinical trials: from cancer nanomedicine to COVID-19 vaccines. Vaccines 9(4). https://doi.org/10.3390/VACCINES9040359
Thornton PS, Maniatis AK, Aghajanova E, Chertok E, Vlachopapadopoulou E, Lin Z, Song W et al (2021) Weekly Lonapegsomatropin in treatment-naïve children with growth hormone deficiency: the phase 3 HeiGHt trial. J Clin Endocrinol Metab 106(11):3184–3195. https://doi.org/10.1210/clinem/dgab529
Turecek PL, Bossard MJ, Schoetens F, Ivens IA (2016) PEGylation of biopharmaceuticals: a review of chemistry and nonclinical safety information of approved drugs. J Pharm Sci 105(2):460–475. https://doi.org/10.1016/j.xphs.2015.11.015
U.S. Food and Drug Administration (2021) FDA approves first interchangeable biosimilar insulin product for treatment of diabetes. FDA News Release 2021. https://www.fda.gov/news-events/press-announcements/fda-approves-first-interchangeable-biosimilar-insulin-product-treatment-diabetes
U.S. Food and Drug Administration (FDA) (2017) Classification of Products as Drugs and Devices & Additional Product Classification Issues: Final Guidance for Industry and FDA Staff. http://www.fda.gov/CombinationProducts/default.htm
UnitedHealthcare (2021) Self-Administered Drug(s) (SAD) UnitedHealthcare ® Medicare Advantage Policy Guideline Self-Administered Drug(s) (SAD)
Veronese FM (2001) Peptide and protein PEGylation: a review of problems and solutions. Biomaterials 22(5):405–417. https://doi.org/10.1016/S0142-9612(00)00193-9
Vinik AI, Wolin EM, Liyanage N, Gomez-Panzani E, Fisher GA (2016) Evaluation of Lanreotide depot/autogel efficacy and safety as A carcinoid syndrome treatment (elect): a randomized, double-blind, placebo-controlled trial. Endocr Pract 22(9):1068–1080. https://doi.org/10.4158/EP151172.OR
Wagner AJ, Ravi V, Riedel RF, Ganjoo K, Van Tine BA, Chugh R, Cranmer L et al (2021) Nab -Sirolimus for patients with malignant perivascular epithelioid cell tumors. J Clin Oncol 39(33):3660–3670. https://doi.org/10.1200/jco.21.01728
Waller CF, Ranganna GM, Pennella EJ, Blakeley C, Bronchud MH, Mattano LA, Berzoy O et al (2019) Randomized phase 3 efficacy and safety trial of proposed Pegfilgrastim biosimilar MYL-1401H in the prophylactic treatment of chemotherapy-induced neutropenia. Ann Hematol 98(5):1217–1224. https://doi.org/10.1007/s00277-019-03639-5
Warner B, Worgul TJ, Drago J, Demers L, Dufau M, Max D, Santen RJ (1983) Effect of very high dose D-Leucine6-gonadotropin-releasing hormone proethylamide on the hypothalamic-pituitary testicular Axis in patients with prostatic cancer. J Clin Investig 71(6):1842–1853. https://doi.org/10.1172/JCI110940
Watson E, Jonker DM, Jacobsen LV, Ingwersen SH (2010) Population pharmacokinetics of Liraglutide, a once-daily human glucagon-like peptide-1 analog, in healthy volunteers and subjects with type 2 diabetes, and comparison to twice-daily exenatide. J Clin Pharmacol 50(8):886–894. https://doi.org/10.1177/0091270009354996
Weinreich T, Leistikow F, Hartmann HG, Vollgraf G, Dellanna F, Kunowski G, Hoffmann HD et al (2012) Monthly continuous erythropoietin receptor activator treatment maintains stable hemoglobin levels in routine clinical management of hemodialysis patients. Hemodial Int 16(1):11–19. https://doi.org/10.1111/J.1542-4758.2011.00608.X
Welt FGP, Rogers C (2002) Inflammation and restenosis in the stent era. Arterioscler Thromb Vasc Biol 22(11):1769–1776. https://doi.org/10.1161/01.ATV.0000037100.44766.5B
Wong EY, Kroon L (2021) Ultra-rapid-acting insulins: how fast is really needed? Clin Diabetes 39(4):415–423. https://doi.org/10.2337/CD20-0119
Wood A (1984) New method of treating neuralgia by the direct application of opiates to the painful points. Surv Anesthesiol 28(4):350. https://doi.org/10.1097/00132586-198408000-00081
Yew NS, Scheule RK (2005) Toxicity of cationic lipid-DNA complexes. Adv Genet 53:189–214. https://doi.org/10.1016/S0065-2660(05)53007-4
Zabner J, Fasbender AJ, Moninger T, Poellinger KA, Welsh MJ (1995) Cellular and molecular barriers to gene transfer by a cationic lipid. J Biol Chem 270(32):18997–18997. https://doi.org/10.1074/jbc.270.32.18997
Zhang S (2003) Fabrication of novel biomaterials through molecular self-assembly. Nat Biotechnol 21(10):1171–1178. https://doi.org/10.1038/nbt874
Zorzi A, Linciano S, Angelini A (2019) Non-covalent albumin-binding ligands for extending the circulating half-life of small biotherapeutics. MedChemComm 10(7):1068. https://doi.org/10.1039/C9MD00018F
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Brown, L.R. (2022). Biomaterials in Their Role in Creating New Approaches for the Delivery of Drugs, Proteins, Nucleic Acids, and Mammalian Cells in Safety Pharmacology. In: Hock, F.J., Gralinski, M.R., Pugsley, M.K. (eds) Drug Discovery and Evaluation: Safety and Pharmacokinetic Assays. Springer, Cham. https://doi.org/10.1007/978-3-030-73317-9_25-1
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