Skip to main content
SpringerLink
Log in

Biomaterials in Their Role in Creating New Approaches for the Delivery of Drugs, Proteins, Nucleic Acids, and Mammalian Cells

  • Reference work entry
Book cover Drug Discovery and Evaluation: Safety and Pharmacokinetic Assays

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 will examine 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, and cells for human use. Each biomaterial-based drug delivery system is unique to the drug, peptide, or protein employed in the system. Therefore, this chapter will focus on the safety considerations along with the therapeutic efficacy offered by this evolving developing area of therapeutics.

This is a preview of subscription content, log in via an institution to check access.

Access this chapter

Log in via an institution
Chapter
USD 29.95
Price excludes VAT (USA)
  • Available as PDF
  • Read on any device
  • Instant download
  • Own it forever
eBook
USD 799.99
Price excludes VAT (USA)
  • Available as EPUB and PDF
  • Read on any device
  • Instant download
  • Own it forever
Hardcover Book
USD 949.99
Price excludes VAT (USA)
  • Durable hardcover edition
  • Dispatched in 3 to 5 business days
  • Free shipping worldwide - see info

Tax calculation will be finalised at checkout

Purchases are for personal use only

Institutional subscriptions

References and Further Reading

  • Adagen® Package Insert, Enzon Pharmaceuticals (2008)

    Google Scholar 

  • Alconcel SN, Baas AS, Maynard HD (2011) FDA-approved poly(ethylene glycol)-protein conjugate drugs. Poly Chem 2:1442–1448

    Article  CAS  Google Scholar 

  • Anthony L, Freda PU (2009) From somatostatin to octreotide LAR: evolution of a somatostatin analogue. Curr Med Res Opin 25(12):2989–2999

    Article  PubMed  CAS  Google Scholar 

  • Atala A, Bauer SB, Soker S, Yoo JJ, Retik AB (2006) Tissue-engineered autologous bladders for patients needing cystoplasty. Lancet 367(9518):1241–1246

    Article  PubMed  Google Scholar 

  • 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

    Article  PubMed  CAS  Google Scholar 

  • Banting FG, Best CH (1922) The internal secretion of the pancreas. J Lab Clin Med 8(5):1–16

    Google Scholar 

  • Berg P, Baltimore D, Bowyer HW, Cohen SN, Hogness DS, Nathans D et al (1974) Potential biohazards of recombinant DNA molecules. Proc Natl Acad Sci USA 71(7):2593–2594

    Article  CAS  Google Scholar 

  • Biological Evaluation of Medical Devices (2007) Retrieved from International Organization of Standardization. http://www.iso.org/iso/home.htm

  • Blundell J (1829) Successful case of transfusion. Lancet 1:431–432

    Google Scholar 

  • Bourges JL, Bloquel C, Thomas A, Froussart F, Bochot A, Azan F et al (2006) Intraocular implants for extended drug delivery: therapeutic applications. Adv Drug Deliv Rev 58:1182–1202

    Article  PubMed  CAS  Google Scholar 

  • Brown LR (2005) Commercial challenges of protein drug delivery. Expert Opin Drug Deliv 2(1):29–42

    Article  PubMed  Google Scholar 

  • Brown L, Munoz C, Siemer L, Edelman E, Langer R (1986) Controlled release of insulin from polymer matrices: control of diabetes in rats. Diabetes 35(6):692–696

    Article  PubMed  CAS  Google Scholar 

  • Bunck MC, Diamant M, Cornér A, Eliasson B, Malloy JL, Shaginian RM et al (2009) One-year treatment with exenatide improves β-cell function, compared with insulin glargine, in metformin-treated type 2 diabetic patients. Diabetes Care 32(5):762–768

    Article  PubMed  CAS  Google Scholar 

  • Burger C, Kabir K, Rangger C, Mueller M, Minor T, Tolba RH (2006) Polylactide (LTS) causes less infammation response than polydioxanone (PDS): a meniscus repair model in sheep. Arch Orthop Trauma Surg 126(10):695–705

    Article  PubMed  Google Scholar 

  • Casadevall N, Nataf J, Viron B, Kolta A, Kiladjian JJ, Martin-Duport P et al (2002) Pure red cell aplasia and antierythropoietin antibodies in patients treated with recombinant erythropoietin. N Eng J Med 346(7):469–475

    Article  CAS  Google Scholar 

  • Center for Devices and Radiological Health (2010) U.S. Food and Drug Administration. Retrieved August 31, 2011, from guidance for industry and FDA staff—non-clinical engineering tests and recommended labeling for intravascular stents and associated delivery systems. http://www.fda.gov/MedicalDevices/DeviceRegulationandGuidance/GuidanceDocuments/ucm071863.htm

  • 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

    Article  PubMed  CAS  Google Scholar 

  • Code of Federal Regulations, Title 21 (2005) Product Jurisdication. Retrieved July 25, 2011, from electronic code of federal regulations. http://ecfr.gpoaccess.gov/cgi/t/text/text-idx?c=ecfr&sid=72ed5148597167f34fa56953ede7b0cf&rgn=div8&view=text&node=21:1.0.1.1.3.1.31.2&idno=21

  • Dailey G, Rosenstock J, Moses RG, Ways K (2004) Insulin Glulisine provides improved glycemic control in patients with type 2 diabetes. Diabetes Care 27:2363–2368

    Article  PubMed  CAS  Google Scholar 

  • DeFelippis MR, Bakaysa DL, Bell MA, Heady MA, Li S, Pye S et al (1988) Preparation and characterization of a cocrystalline suspension of [LysB28, ProB29]-human insulin analogue. J Pharm Sci 87(2):170–176

    Article  Google Scholar 

  • Dippenaar JM (2007) Local anaesthetic toxicity. South Afr J Anesth Analg 13(3):23–28

    Google Scholar 

  • Duckworth WC, Bennett RG, Hamel FG (1998) Insulin degradation: progress and potential. Endocr Rev 19(5):608–624

    Article  PubMed  CAS  Google Scholar 

  • Ellis-Behnke RG, Liang YX, You SW, Tay DK, Zhang S, So KF et al (2006) Nano neuro knitting: peptide nanofiber scaffold for brain repair and axon regeneration with functional return of vision. Proc Natl Acad Sci USA 103(13):2006

    Article  Google Scholar 

  • Erichen JE (1874) Hospitalism and the causes of death after operations. Br. Med J. 1:65–67

    Article  Google Scholar 

  • European Medicines Agency (2006) Concept paper on guideline on immunogenicity of therapeutic proteins. European Medicines Agency, London, Doc. Ref. EMEA/CHMP/BMWP/246511/2005

    Google Scholar 

  • 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 391:806–811

    Article  PubMed  CAS  Google Scholar 

  • Fischer J, Edelman S, Schwartz S (2008) United States patient preference and usability for new disposable insulin device Solostar® versus other disposible pens. J Diabetes Sci Technol 2(6):1157–1160

    PubMed  Google Scholar 

  • Fry DW, Richardson KE (1979) Isolation and characterization of glycolic acid dehydrogenase from human liver. Biochim Biophys Acta (BBA) Enzymol 567(2):482–491

    Article  CAS  Google Scholar 

  • Fung AE, Lalwani GA, Rosenfeld PJ, Dobovy SR, Michels S, Feuer WJ et al (2007) An optical coherence tomography-guided, variable dosing regimen with intravitreal ranibizumab (Lucentis) for neovascular Age-related macular degeneration. Am J Ophthalmol 143(2):566–583

    Article  PubMed  CAS  Google Scholar 

  • Gillies PS, Figgitt DP, Lamb HM (2000) Insulin gIargine. Drugs 59:199–260

    Google Scholar 

  • Hagedorn HC, Jensen BN, Wodstrup K, Karup NB (1936) Protamine insulinate. J Am Med Assoc 106(3):177–180

    Article  CAS  Google Scholar 

  • Hallas-Moller K, Jersild M, Peterson K, Schlichtkrull J (1952) Insulin preparations for single daily injection, clinical studies of new preparations with prolonged action. J Am Med Assoc 150(17):1667–1671

    Article  Google Scholar 

  • Heathcote EJ, Shiffman ML, Cooksley WG, Dusheiko GM, Lee SS, Balart L et al (2000) Peginterferon alfa-2a in patients with chronic hepatitis C and cirrhosis. N Engl J Med 343(23):1673–1680

    Article  PubMed  CAS  Google Scholar 

  • 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 55:199–203

    Article  PubMed  CAS  Google Scholar 

  • Hwang CW, Wu D, Edelman ER (2001) Physiological transport forces govern drug distribution for stent-based delivery. Circulation 104:600–605

    Article  PubMed  CAS  Google Scholar 

  • Indepdence Blue Cross (2010) Self-injectable drug list. Retrieved August 31, 2011, from Indepdence Blue Cross. http://www.ibx.com/pdfs/providers/communications/update/supplementary/self_injectable_druglist_ibc.pdf

  • International Organization for Standardization (2010) Biological evaluation of medical devices, parts 1–20. International Organization for Standardization, Geneva

    Google Scholar 

  • Kessler M, Goldsmith D, Schellekens H (2006) Immunogenicity of biopharmaceuticals. Nephrol Dial Transplant 21(Suppl 5):v9–v12

    Article  PubMed  CAS  Google Scholar 

  • Knobil E (1990) The GnRH pulse generator. Am J Obstet Gynecol 163:1721–1727

    PubMed  CAS  Google Scholar 

  • Kozlowski A, Harris JM (2001) Improvements in protein PEGylation: pegylated interferons for treatment of hepatitis C. J Control Release 72:217–224

    Article  PubMed  CAS  Google Scholar 

  • Lancranjan I, Bruns C, Grass P, Jaquet P, Jervell J, Kendall-Taylor P et al (1996) Sandostatin LAR®: pharmacokinetics, pharmacodynamics, efficacy, and tolerability in acromegalic patients. Metabolism 44(S1):18–26

    Google Scholar 

  • Landsteiner K (1900) Zur kenntnis der antifermentativen, lytischen und agglutinierenden wirkungen des blutserums und der lymphe. Centralbl Bakteriol 27:357–362

    Google Scholar 

  • Leacock JH (1817) On transfusion of blood in extreme cases of haemorrhage. Med Chir J Rev 3:276–284

    Google Scholar 

  • Learoyd P (2006) A short history of blood transfusion. Scientific and Technical Training, STT-042

    Google Scholar 

  • Levemir® Insulin Detemir (rDNA) Injection, Package Insert Novo Nordisk

    Google Scholar 

  • Lister J (1867) On the antiseptic principle in the practise of surgery. Br Med J 2(351):246–248

    Article  PubMed  CAS  Google Scholar 

  • Lower R (1932). Tractatus de corde item de motu et colore sanguinis et chyli in cum transitu (1669). In: Gunther RT (ed) Early science in Oxford: biological sciences and biological collections, Facsimile edn. Dawsons Pall Mall, London, p 9

    Google Scholar 

  • 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. Diabetes Care 35(7):434–438

    CAS  Google Scholar 

  • 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

    Article  PubMed  CAS  Google Scholar 

  • Macdougall IC, Padhi D, Jang G (2007) Pharmacology of darbepoetin alfa. Nephrol Dial Transplant 22(4):iv2–iv9

    Article  PubMed  Google Scholar 

  • Meade KR, Silver FH (1990) Immunogenicity of collagenous implants. Biomaterials 11(3):176–180

    Article  PubMed  CAS  Google Scholar 

  • Mehvar R (2000) Modulation of the pharmacokinetics and pharmacodynamics of proteins by polyethylene glycol conjugation. J Pharm Sci 3(1):125–136

    CAS  Google Scholar 

  • Morice M-C, Serruys PW, Barragan P, Bode C, Van Es G-A, Stoll HP et al (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

    Article  PubMed  CAS  Google Scholar 

  • Morrow JF, Cohen SN, Chang AC, Boyer HW, Goodman HM, Helling RB (1974) Replication and transcription of eukaryotic DNA in Escherichia coli. Proc Natl Acad Sci USA 71(5):1743–1747

    Article  PubMed  CAS  Google Scholar 

  • Naik G (2011) Lab-made trachea saves man. The Wall Street Journal, July 8

    Google Scholar 

  • Neulasta® Package Insert, Amgen, Inc. (2002)

    Google Scholar 

  • Nutropin Depot Package Insert (1999)

    Google Scholar 

  • Nutropin Depot®, Genentech, Inc. (2002)

    Google Scholar 

  • Office of combination products Food and Drug Administration (2011) Classification of products as drugs and devices & additional product classification issues. Retrieved from FDA. http://www.fda.gov/downloads/RegulatoryInformation/Guidances/UCM258957.pdf

  • Okada H (1997) One- and three-month release injectable microspheres of the LH-RH superagonist leuprorelin acetate. Adv Drug Deliv Rev 28(1):43–70

    Article  PubMed  CAS  Google Scholar 

  • Overbay DK, Manley HJ (2002) Darbepoetin-alpha: a review of the literature. Pharmacotherapy 22(7):889–897

    Article  PubMed  CAS  Google Scholar 

  • R&D Directorate Report No. 54 (1996) Coserelin or other gonadotrophin releasing hormone (GnRH) analogues in the treatment of advanced prostate cancer. NHS executive south and west, report to the development and evaluation committee

    Google Scholar 

  • Retisert Package Insert, Bausch & Lomb (2009)

    Google Scholar 

  • Russel-Jones D (2009) Molecular, pharmacological and clinical aspects of liraglutide, a once-daily human GLP-1 analogue. Mol Cell Endocrinol 297:137–140

    Article  Google Scholar 

  • Rynd F (1845) Neuralgia - introduction of fluid to the nerve. Dublin Medical Press 13:167–168.

    Google Scholar 

  • Scarpignato C, Pelonsini IS (2001) Somatostatin analogs for cancer treatment and diagnosis: an overview. Chemotherapy 47(2):1–29

    Article  PubMed  CAS  Google Scholar 

  • Schmidt PJ, Leacock AG (2002) Forgotten transfusion history: John Leacock of Barbados. Br Med J 325:1485–1487

    Article  CAS  Google Scholar 

  • Schorr MR (1966) Needles, some points to think about. Curr Res Anesth Analg 45(4):509–513

    CAS  Google Scholar 

  • Schreiber I, Buchfelder M, Droste M, Forssmann K, Mann K, Saller B et al (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 156:75–82

    Article  PubMed  CAS  Google Scholar 

  • Siegel JD, Rhinehart E, Jackson M, Chiarello L (2007) 2007 Guidelines for isolation precaustions: preventing transmission of Infectious agents in healthcare settings. Retrieved from Center for Disease Control. http://www.cdc.gov/hicpac/pdf/isolation/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 316:701–706

    Article  PubMed  CAS  Google Scholar 

  • Tsuji T, Tamai H, Igaki K, Kyo E, Kosuga K, Hata T et al (2003) Biodegradable stents as a platform to drug loading. Int J Cardiovasc Intervent 5(1):13–16

    PubMed  Google Scholar 

  • Veronese FM (2001) Peptide and protein PEGylation: a review of problems and solutions. Biomaterials 22(5):405–417

    Article  PubMed  CAS  Google Scholar 

  • Vitrasert Package Insert, Bausch & Lomb (2003)

    Google Scholar 

  • Warner B, Worgul TJ, Drago J, Demers L, Dafau M, Max D et al (1983) Effect of very high dose d-leucine6-gonadotropin-releasing hormone proethylamide on the hypothalmic-pituitary testicular axis in patients with prostatic cancer. J Clin Invest 71(6):1842–1853

    Article  PubMed  CAS  Google Scholar 

  • Watson E, Jonker DM, Jaconsen LV, Ingwersen SH (2010) Opulation 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

    Article  PubMed  CAS  Google Scholar 

  • Wood A (1855) New methods of treating neuralgia by the direct of opiates to the painful points. Edinburgh Med Surg J 16:265–281

    Google Scholar 

  • Yew NS, Scheule RK (2005) Toxicity of cationic lipid-DNA complexes. Adv Genet 53:189–214

    Article  PubMed  CAS  Google Scholar 

  • Yilin C, Vacanti JP, Paige KT, 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

    Article  Google Scholar 

  • 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 270:18997–19007

    Article  PubMed  CAS  Google Scholar 

  • Zhang S (2003) Fabrication of novel biomaterials through molecular self-assembly. Nat Biotechnol 21(10):1171–1178

    Article  PubMed  CAS  Google Scholar 

Download references

Author information

Authors and Affiliations

  1. MIT, Cambridge, MA, 02139, USA

    Dr. Larry R. Brown

Authors
  1. Dr. Larry R. Brown
    View author publications

    You can also search for this author in PubMed Google Scholar

Corresponding author

Correspondence to Larry R. Brown .

Editor information

Editors and Affiliations

  1. Sanofi Pharma Deutschland GmbH, A company of the Sanofi-Aventis Group Industriepark Hoechst, Frankfurt am Main, Germany

    Jochen Maas

  2. Dieburg, Germany

    Franz J. Hock

  3. Idstein, Germany

    Dieter Mayer

Rights and permissions

Reprints and permissions

Copyright information

© 2013 Springer-Verlag Berlin Heidelberg

About this entry

Cite this entry

Brown, L.R. (2013). Biomaterials in Their Role in Creating New Approaches for the Delivery of Drugs, Proteins, Nucleic Acids, and Mammalian Cells. In: Vogel, H.G., Maas, J., Hock, F.J., Mayer, D. (eds) Drug Discovery and Evaluation: Safety and Pharmacokinetic Assays. Springer, Berlin, Heidelberg. https://doi.org/10.1007/978-3-642-25240-2_25

Download citation

Publish with us

Policies and ethics

Search

Navigation