Delivery Technologies for Biopharmaceuticals
Peptides, Proteins, Nucleic Acids and Vaccines
Herausgeber: Jorgensen, Lene; Nielson, Hanne Morck
Delivery Technologies for Biopharmaceuticals
Peptides, Proteins, Nucleic Acids and Vaccines
Herausgeber: Jorgensen, Lene; Nielson, Hanne Morck
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Advances in biotechnology have provided scientists with an increasing number of biopharmaceuticals such as novel peptide and protein drugs as well as nucleic acid based drugs for gene therapy. However, successful delivery of these biopharmaceuticals is a major challenge because their molecular properties lead to poor physical and chemical stability in the body and limited membrane permeability. Therefore researchers are developing a range of new delivery technologies and materials to enable these new drugs to be delivered intact to their target sites. Delivery Technologies for…mehr
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- Produktdetails
- Verlag: John Wiley & Sons / Wiley
- Seitenzahl: 442
- Erscheinungstermin: 26. Januar 2010
- Englisch
- Abmessung: 249mm x 173mm x 28mm
- Gewicht: 885g
- ISBN-13: 9780470723388
- ISBN-10: 0470723386
- Artikelnr.: 28162503
- Verlag: John Wiley & Sons / Wiley
- Seitenzahl: 442
- Erscheinungstermin: 26. Januar 2010
- Englisch
- Abmessung: 249mm x 173mm x 28mm
- Gewicht: 885g
- ISBN-13: 9780470723388
- ISBN-10: 0470723386
- Artikelnr.: 28162503
Biopharmaceuticals; the Need for Advanced Delivery Systems (Hanne Mørck
Nielsen and Lene Jorgensen). 1.1 Introduction. 1.2 Overcoming Delivery
Barriers. 1.3 Drug Delivery Technologies and Excipients. 1.4 Risks. 1.5
Conclusion. References. DELIVERY OF BIOPHARMACEUTICALS. 2. Novel
Formulation Approaches for Peptide and Protein Injectables (Mingshi Yang
and Sven Frokjaer). 2.1 Introduction. 2.2 Formulation Challenges. 2.3
Chemical Modification of Proteins and Peptides. 2.4 Depot Delivery Systems.
2.5 Other Delivery Systems. 2.6 Conclusions. References. 3. Novel
Non-Injectable Formulation Approaches of Peptides and Proteins (Shirui Mao,
Dongmei Cun and Yoshiaki Kawashima). 3.1 Introduction. 3.2 Intranasal
Delivery of Peptide/Protein Drugs. 3.3 Pulmonary Delivery of
Peptide/Protein Drugs. 3.4 Buccal Administration of Peptide/Protein Drugs.
3.5 Oral Delivery of Peptide/Protein Drugs. 3.6 Transdermal Delivery of
Peptide/Protein Drugs. 3.7 Conclusions. References. 4. Chemical Vectors for
Delivery of Nucleic Acid-Based Drugs (Elizabeth A. Vasievich and Leaf
Huang). 4.1 Introduction. 4.2 Barriers to Delivery of Nucleic Acids. 4.3
Major Classes of Delivery Vectors. 4.4 Targeted Delivery. 4.5 Triggered
Release. 4.6 Recent Clinical Trials Using Naked and Chemically Complexed
Nucleic Acids. 4.7 Conclusion. References. 5. Viral Technology for Delivery
of Nucleic Acids (Shervin Bahrami and Finn Skou Pedersen). 5.1
Introduction. 5.2 Barriers and Topological Requirements to Cellular Entry.
5.3 Routes of Administration. 5.4 Delivery Vector Requirements. 5.5
Examples of Viral Delivery Technology. 5.6 Conclusion. References. 6. The
Innate Immune Responses, Adjuvants and Delivery Systems (S. Moein Moghimi).
6.1 Introduction. 6.2 Dendritic Cell Immunobiology. 6.3 Antigen Capture.
6.4 Particulate Antigen Delivery Systems. 6.5 Signalling Receptors and the
Role of Adjuvants. 6.6 Conclusions. References. DELIVERY TECHNOLOGIES FOR
BIOPHARMACEUTICALS. 7. Lipid Nanoparticle-Based Systems for Delivery of
Biomacromolecule Therapeutics (Susana Martins, Domingos C. Ferreira and
Eliana B. Souto). 7.1 Introduction. 7.2 Definitions and Properties of Solid
Lipid Nanoparticles (SLNs). 7.3 Definitions and Properties of Lipid-Drug
Conjugates (LDCs). 7.4 Administration, Delivery and Targeting. 7.5 Toxicity
and Safety. 7.6 Applications for Biopharmaceuticals. 7.7 Conclusions.
References. 8. Dendrimers in Delivery of Biopharmaceuticals (Chandan Thomas
and Fakhrul Ahsan). 8.1 Introduction. 8.2 Case I -- Application of
Dendrimers in Delivery of Large Molecular Weight Drugs. 8.3 Case II --
Application of Dendrimers in Gene Delivery. 8.4 Case III -- Application of
Dendrimers in Vaccine Delivery. 8.5 Concluding Remarks. References.
PEPTIDES AND PROTEINS. 9. Modifi cation of Peptides and Proteins (Susanne
Hostrup, Kasper Huus and Henrik Parshad). 9.1 Introduction. 9.2 PEGylated
Peptides and Proteins. 9.3 Lipidization of Peptides and Proteins. 9.4
Modification of the Primary Structure of Peptides and Proteins. 9.5 General
Considerations on Processing and Characterization. 9.6 Conclusions.
References. 10. Nanocarriers for the Delivery of Peptides and Proteins
(Kenneth Lundstrom). 10.1 Introduction. 10.2 Polymeric Nanoparticles. 10.3
In Situ Depot Forming Systems. 10.4 Conclusions. References. 11.
Polymer-Based Delivery Systems for Oral Delivery of Peptides and Proteins
(Bruno Sarmento, Domingos Ferreira and Teófi lo Vasconcelos). 11.1
Introduction. 11.2 Advances in Oral Protein Delivery. 11.3 Intestinal
Considerations for Protein Absorption. 11.4 Polymer-Based Delivery Systems
for Oral Delivery of Proteins. 11.5 Conclusions. References. 12. Advanced
Pulmonary Delivery of Peptides or Proteins Using Polymeric Particles (Yu
Seok Youn, Kang Choon Lee, You Han Bae, Kun Na and Eun Seong Lee). 12.1
Introduction. 12.2 Practical Issues in the Pulmonary Delivery of Peptides
and Proteins. 12.3 Polymeric Microparticles for Delivering Peptides and
Proteins. 12.4 Porous Microparticles. 12.5 Polymeric Nanoparticles. 12.6
Sustained or Controlled Release Issues in Polymeric Particle Formulations.
12.7 Stability Issues of Peptides and Proteins in Particles. 12.8 Toxicity
Issues of Inhaled Particles. 12.9 Conclusions. References. NUCLEIC ACIDS.
13. Polymer Microparticles for Nucleic Acid Delivery (Tim Pearce, Jared
Hierman and Chun Wang). 13.1 Introduction. 13.2 Microparticles Based on
Poly(Lactic-co-Glycolic Acids) (PLGA). 13.3 Other Types of Polymer
Microparticles. 13.4 Conclusions. References. 14. Pulmonary Delivery of
Small Interfering RNA for Novel Therapeutics (Qing Ge, David Evans, John J.
Xu, Harry H. Yang and Patrick Y. Lu). 14.1 Introduction. 14.2 RNA
Interference: Mechanism of Action. 14.3 Lung Physiology. 14.4 Animal
Models. 14.5 siRNA Delivery to Treat Pulmonary Diseases. 14.6 siRNA-Induced
Infl ammatory Response. 14.7 Case Studies. 14.8 Faster Drug for Unknown
Bugs. 14.9 Conclusions. References. 15. Lipid-Based Formulations for siRNA
Delivery (Camilla Foged, Pieter Vader and Raymond M. Schiffelers). 15.1
Introduction. 15.2 Cationic Lipid-Based Delivery Systems for Nucleic
Acid-Based Drugs. 15.3 Neutral and Anionic Lipid-Based Drug Delivery
Systems. 15.4 Mechanisms of Internalization. 15.5 Immune Activation. 15.6
Conclusions. References. 16. Cellular Bioavailability of Peptide Nucleic
Acids (PNAs) Conjugated to Cell Penetrating Peptides (Takehiko Shiraishi
and Peter E. Nielsen). 16.1 Introduction. 16.2 Peptide Nucleic Acids
(PNAs). 16.3 Cell Penetrating Peptides (CPPs). 16.4 Cellular Uptake Versus
Bioavailability. 16.5 PNA Conjugates. 16.6 Efficacy Versus Effi ciency.
16.7 Auxiliary Agents. 16.8 In Vivo Activity of PNA Conjugates. 16.9
Conclusions. References. 17. DEAE-dextran-MMA Graft Copolymer for Non-Viral
Delivery of DNA (Yasuhiko Onishi, Yuki Eshita and Masaaki Mizuno). 17.1
Introduction. 17.2 Theoretical. 17.3 Materials and Methods. 17.4
Conclusions. References. VACCINES. 18. Liposomes in Adjuvant Systems for
Parenteral Delivery of Vaccines (Dennis Christensen, Karen Korsholm, Grith
Krøyer Wood, Afzal Mohammed, Vincent Bramwell, Peter Andersen, Else Marie
Agger and Yvonne Perrie). 18.1 The Structural Basis of Liposomes. 18.2 Key
Characteristics Which Make Liposomes Advantagous as Vaccine Delivery
Systems. 18.3 Formulation Approaches to Improve Adjuvanticity and Enhance
Immunological Targeting. 18.4 Instability Considerations of Liposomes. 18.5
Techniques to Formulate Long-Term Stable Liposome Formulations. 18.6
Conclusion. References. 19. Influenza Virosomes as Delivery Systems for
Antigens (Mario Amacker, Stefan Moese, Andreas R. Kammer, Ari Helenius and
Rinaldo Zurbriggen). 19.1 Introduction. 19.2 A Case Study --
Antigen-Virosome Drug Delivery System. 19.3 Methods. References. 20.
GRAZAX: An Oromucosal Vaccine for Treating Grass Pollen Allergy with
Immunotherapy (Annette Römmelmayer Lundegaard, Lise Lund and Jørgen
Nedergaard Larsen). 20.1 Introduction. 20.2 Specific Immunotherapy. 20.3
Description of Grass Pollen Extract. 20.4 Technologies of Fast Dissolving
Tablets. 20.5 Formulation of GRAZAX. 20.6 Production of GRAZAX. 20.7
Specifications and Analytical Procedures. 20.8 Feasibility Study:
Additional Analyses. 20.9 Conclusions. References. FINAL COMMENTS. 21.
Delivery Technologies for Biopharmaceuticals: A Critical Assessment (Marco
van de Weert). 21.1 Introduction. 21.2 Large Scale Production and
Reproducibility. 21.3 Safety Concerns. 21.4 Cost-Benefit Ratio. 21.5
Conclusion. References. Index.
Biopharmaceuticals; the Need for Advanced Delivery Systems (Hanne Mørck
Nielsen and Lene Jorgensen). 1.1 Introduction. 1.2 Overcoming Delivery
Barriers. 1.3 Drug Delivery Technologies and Excipients. 1.4 Risks. 1.5
Conclusion. References. DELIVERY OF BIOPHARMACEUTICALS. 2. Novel
Formulation Approaches for Peptide and Protein Injectables (Mingshi Yang
and Sven Frokjaer). 2.1 Introduction. 2.2 Formulation Challenges. 2.3
Chemical Modification of Proteins and Peptides. 2.4 Depot Delivery Systems.
2.5 Other Delivery Systems. 2.6 Conclusions. References. 3. Novel
Non-Injectable Formulation Approaches of Peptides and Proteins (Shirui Mao,
Dongmei Cun and Yoshiaki Kawashima). 3.1 Introduction. 3.2 Intranasal
Delivery of Peptide/Protein Drugs. 3.3 Pulmonary Delivery of
Peptide/Protein Drugs. 3.4 Buccal Administration of Peptide/Protein Drugs.
3.5 Oral Delivery of Peptide/Protein Drugs. 3.6 Transdermal Delivery of
Peptide/Protein Drugs. 3.7 Conclusions. References. 4. Chemical Vectors for
Delivery of Nucleic Acid-Based Drugs (Elizabeth A. Vasievich and Leaf
Huang). 4.1 Introduction. 4.2 Barriers to Delivery of Nucleic Acids. 4.3
Major Classes of Delivery Vectors. 4.4 Targeted Delivery. 4.5 Triggered
Release. 4.6 Recent Clinical Trials Using Naked and Chemically Complexed
Nucleic Acids. 4.7 Conclusion. References. 5. Viral Technology for Delivery
of Nucleic Acids (Shervin Bahrami and Finn Skou Pedersen). 5.1
Introduction. 5.2 Barriers and Topological Requirements to Cellular Entry.
5.3 Routes of Administration. 5.4 Delivery Vector Requirements. 5.5
Examples of Viral Delivery Technology. 5.6 Conclusion. References. 6. The
Innate Immune Responses, Adjuvants and Delivery Systems (S. Moein Moghimi).
6.1 Introduction. 6.2 Dendritic Cell Immunobiology. 6.3 Antigen Capture.
6.4 Particulate Antigen Delivery Systems. 6.5 Signalling Receptors and the
Role of Adjuvants. 6.6 Conclusions. References. DELIVERY TECHNOLOGIES FOR
BIOPHARMACEUTICALS. 7. Lipid Nanoparticle-Based Systems for Delivery of
Biomacromolecule Therapeutics (Susana Martins, Domingos C. Ferreira and
Eliana B. Souto). 7.1 Introduction. 7.2 Definitions and Properties of Solid
Lipid Nanoparticles (SLNs). 7.3 Definitions and Properties of Lipid-Drug
Conjugates (LDCs). 7.4 Administration, Delivery and Targeting. 7.5 Toxicity
and Safety. 7.6 Applications for Biopharmaceuticals. 7.7 Conclusions.
References. 8. Dendrimers in Delivery of Biopharmaceuticals (Chandan Thomas
and Fakhrul Ahsan). 8.1 Introduction. 8.2 Case I -- Application of
Dendrimers in Delivery of Large Molecular Weight Drugs. 8.3 Case II --
Application of Dendrimers in Gene Delivery. 8.4 Case III -- Application of
Dendrimers in Vaccine Delivery. 8.5 Concluding Remarks. References.
PEPTIDES AND PROTEINS. 9. Modifi cation of Peptides and Proteins (Susanne
Hostrup, Kasper Huus and Henrik Parshad). 9.1 Introduction. 9.2 PEGylated
Peptides and Proteins. 9.3 Lipidization of Peptides and Proteins. 9.4
Modification of the Primary Structure of Peptides and Proteins. 9.5 General
Considerations on Processing and Characterization. 9.6 Conclusions.
References. 10. Nanocarriers for the Delivery of Peptides and Proteins
(Kenneth Lundstrom). 10.1 Introduction. 10.2 Polymeric Nanoparticles. 10.3
In Situ Depot Forming Systems. 10.4 Conclusions. References. 11.
Polymer-Based Delivery Systems for Oral Delivery of Peptides and Proteins
(Bruno Sarmento, Domingos Ferreira and Teófi lo Vasconcelos). 11.1
Introduction. 11.2 Advances in Oral Protein Delivery. 11.3 Intestinal
Considerations for Protein Absorption. 11.4 Polymer-Based Delivery Systems
for Oral Delivery of Proteins. 11.5 Conclusions. References. 12. Advanced
Pulmonary Delivery of Peptides or Proteins Using Polymeric Particles (Yu
Seok Youn, Kang Choon Lee, You Han Bae, Kun Na and Eun Seong Lee). 12.1
Introduction. 12.2 Practical Issues in the Pulmonary Delivery of Peptides
and Proteins. 12.3 Polymeric Microparticles for Delivering Peptides and
Proteins. 12.4 Porous Microparticles. 12.5 Polymeric Nanoparticles. 12.6
Sustained or Controlled Release Issues in Polymeric Particle Formulations.
12.7 Stability Issues of Peptides and Proteins in Particles. 12.8 Toxicity
Issues of Inhaled Particles. 12.9 Conclusions. References. NUCLEIC ACIDS.
13. Polymer Microparticles for Nucleic Acid Delivery (Tim Pearce, Jared
Hierman and Chun Wang). 13.1 Introduction. 13.2 Microparticles Based on
Poly(Lactic-co-Glycolic Acids) (PLGA). 13.3 Other Types of Polymer
Microparticles. 13.4 Conclusions. References. 14. Pulmonary Delivery of
Small Interfering RNA for Novel Therapeutics (Qing Ge, David Evans, John J.
Xu, Harry H. Yang and Patrick Y. Lu). 14.1 Introduction. 14.2 RNA
Interference: Mechanism of Action. 14.3 Lung Physiology. 14.4 Animal
Models. 14.5 siRNA Delivery to Treat Pulmonary Diseases. 14.6 siRNA-Induced
Infl ammatory Response. 14.7 Case Studies. 14.8 Faster Drug for Unknown
Bugs. 14.9 Conclusions. References. 15. Lipid-Based Formulations for siRNA
Delivery (Camilla Foged, Pieter Vader and Raymond M. Schiffelers). 15.1
Introduction. 15.2 Cationic Lipid-Based Delivery Systems for Nucleic
Acid-Based Drugs. 15.3 Neutral and Anionic Lipid-Based Drug Delivery
Systems. 15.4 Mechanisms of Internalization. 15.5 Immune Activation. 15.6
Conclusions. References. 16. Cellular Bioavailability of Peptide Nucleic
Acids (PNAs) Conjugated to Cell Penetrating Peptides (Takehiko Shiraishi
and Peter E. Nielsen). 16.1 Introduction. 16.2 Peptide Nucleic Acids
(PNAs). 16.3 Cell Penetrating Peptides (CPPs). 16.4 Cellular Uptake Versus
Bioavailability. 16.5 PNA Conjugates. 16.6 Efficacy Versus Effi ciency.
16.7 Auxiliary Agents. 16.8 In Vivo Activity of PNA Conjugates. 16.9
Conclusions. References. 17. DEAE-dextran-MMA Graft Copolymer for Non-Viral
Delivery of DNA (Yasuhiko Onishi, Yuki Eshita and Masaaki Mizuno). 17.1
Introduction. 17.2 Theoretical. 17.3 Materials and Methods. 17.4
Conclusions. References. VACCINES. 18. Liposomes in Adjuvant Systems for
Parenteral Delivery of Vaccines (Dennis Christensen, Karen Korsholm, Grith
Krøyer Wood, Afzal Mohammed, Vincent Bramwell, Peter Andersen, Else Marie
Agger and Yvonne Perrie). 18.1 The Structural Basis of Liposomes. 18.2 Key
Characteristics Which Make Liposomes Advantagous as Vaccine Delivery
Systems. 18.3 Formulation Approaches to Improve Adjuvanticity and Enhance
Immunological Targeting. 18.4 Instability Considerations of Liposomes. 18.5
Techniques to Formulate Long-Term Stable Liposome Formulations. 18.6
Conclusion. References. 19. Influenza Virosomes as Delivery Systems for
Antigens (Mario Amacker, Stefan Moese, Andreas R. Kammer, Ari Helenius and
Rinaldo Zurbriggen). 19.1 Introduction. 19.2 A Case Study --
Antigen-Virosome Drug Delivery System. 19.3 Methods. References. 20.
GRAZAX: An Oromucosal Vaccine for Treating Grass Pollen Allergy with
Immunotherapy (Annette Römmelmayer Lundegaard, Lise Lund and Jørgen
Nedergaard Larsen). 20.1 Introduction. 20.2 Specific Immunotherapy. 20.3
Description of Grass Pollen Extract. 20.4 Technologies of Fast Dissolving
Tablets. 20.5 Formulation of GRAZAX. 20.6 Production of GRAZAX. 20.7
Specifications and Analytical Procedures. 20.8 Feasibility Study:
Additional Analyses. 20.9 Conclusions. References. FINAL COMMENTS. 21.
Delivery Technologies for Biopharmaceuticals: A Critical Assessment (Marco
van de Weert). 21.1 Introduction. 21.2 Large Scale Production and
Reproducibility. 21.3 Safety Concerns. 21.4 Cost-Benefit Ratio. 21.5
Conclusion. References. Index.