{"product_id":"chitosanbased-systems-for-biopharmaceuticals-9780470978320","title":"ChitosanBased Systems for Biopharmaceuticals","description":"\u003cb\u003eBook Synopsis\u003c\/b\u003e\u003cbr\u003eChitosan is a linear polysaccharide commercially produced by the deacetylation of chitin. It is non-toxic, biodegradable, biocompatible, and acts as a bioadhesive with otherwise unstable biomolecules - making it a valuable component in the formulation of biopharmaceutical drugs.  \u003cp\u003e\u003ci\u003eChitosan-Based Systems for Biopharmaceuticals\u003c\/i\u003e provides an extensive overview of the application of chitosan and its derivatives in the development and optimisation of biopharmaceuticals. The book is divided in four different parts. Part I discusses general aspects of chitosan and its derivatives, with particular emphasis on issues related to the development of biopharmaceutical chitosan-based systems. Part II deals with the use of chitosan and derivatives in the formulation and delivery of biopharmaceuticals, and focuses on the synergistic effects between chitosan and this particular subset of pharmaceuticals. Part III discusses specific applications of chitosan and its derivatives for biopharmaceuti\u003cbr\u003e\u003cbr\u003e\u003cb\u003eTable of Contents\u003c\/b\u003e\u003cbr\u003eList of Contributors xvii  \u003c\/p\u003e\u003cp\u003eForeword xxiii\u003cbr\u003e \u003ci\u003eMarıa Jose Alonso\u003c\/i\u003e\u003c\/p\u003e \u003cp\u003ePreface xxv\u003c\/p\u003e \u003cp\u003eAcknowledgments xxvii\u003c\/p\u003e \u003cp\u003e\u003cb\u003ePart One General Aspects of Chitosan 1\u003c\/b\u003e\u003c\/p\u003e \u003cp\u003e\u003cb\u003e1 Chemical and Technological Advances in Chitins and Chitosans Useful for the Formulation of Biopharmaceuticals 3\u003c\/b\u003e\u003cbr\u003e \u003ci\u003eRiccardo A. A. Muzzarelli\u003c\/i\u003e\u003c\/p\u003e \u003cp\u003e1.1 Introduction 3\u003c\/p\u003e \u003cp\u003e1.2 Safety of Chitins and Chitosans 4\u003c\/p\u003e \u003cp\u003e1.3 Ionic Liquids: New Solvents and Reaction Media 5\u003c\/p\u003e \u003cp\u003e1.4 Chitin and Chitosan Nanofibrils 8\u003c\/p\u003e \u003cp\u003e1.5 Electrospun Nanofibers 10\u003c\/p\u003e \u003cp\u003e1.6 Polyelectrolyte Complexes and Mucoadhesion 12\u003c\/p\u003e \u003cp\u003e1.7 Conclusions and Future Perspectives 16\u003c\/p\u003e \u003cp\u003e\u003cb\u003e2 Physical Properties of Chitosan and Derivatives in Sol and Gel States 23\u003c\/b\u003e\u003cbr\u003e \u003ci\u003eMarguerite Rinaudo\u003c\/i\u003e\u003c\/p\u003e \u003cp\u003e2.1 Introduction 23\u003c\/p\u003e \u003cp\u003e2.2 Chitin 24\u003c\/p\u003e \u003cp\u003e2.3 Chitosan 28\u003c\/p\u003e \u003cp\u003e2.4 Conclusions and Future Perspectives 36\u003c\/p\u003e \u003cp\u003e\u003cb\u003e3 Absorption Promotion Properties of Chitosan and Derivatives 45\u003c\/b\u003e\u003cbr\u003e \u003ci\u003eAkira Yamamoto\u003c\/i\u003e\u003c\/p\u003e \u003cp\u003e3.1 Introduction 45\u003c\/p\u003e \u003cp\u003e3.2 Effect of Chitosan on the Intestinal Absorption of Poorly Absorbable Drugs 47\u003c\/p\u003e \u003cp\u003e3.3 Effect of Chitosan Derivatives on the Intestinal Absorption of Poorly Absorbable Drugs 47\u003c\/p\u003e \u003cp\u003e3.4 Effect of Chitosan Oligomers on the Intestinal Absorption of Poorly Absorbable Drugs 48\u003c\/p\u003e \u003cp\u003e3.5 Colon-Specific Delivery of Insulin Using Chitosan Capsules 51\u003c\/p\u003e \u003cp\u003e3.6 Conclusions and Future Perspectives 54\u003c\/p\u003e \u003cp\u003e\u003cb\u003e4 Biocompatibility and Biodegradation of Chitosan and Derivatives 57\u003c\/b\u003e\u003cbr\u003e \u003ci\u003eAhmad Sukari Halim, Lim Chin Keong, Ismail Zainol, and Ahmad Hazri Abdul Rashid\u003c\/i\u003e\u003c\/p\u003e \u003cp\u003e4.1 Introduction 57\u003c\/p\u003e \u003cp\u003e4.2 Biocompatibility Evaluation of Chitosan and Derivatives 58\u003c\/p\u003e \u003cp\u003e4.3 Biodegradation of Chitosan and Derivatives 65\u003c\/p\u003e \u003cp\u003e4.4 Conclusions and Future Perspectives 69\u003c\/p\u003e \u003cp\u003e\u003cb\u003e5 Biological and Pharmacological Activity of Chitosan and Derivatives 75\u003c\/b\u003e\u003cbr\u003e \u003ci\u003eTeresa Cunha, Branca Teixeira, Barbara Santos, Marlene Almeida, Gustavo Dias, and Jose das Neves\u003c\/i\u003e\u003c\/p\u003e \u003cp\u003e5.1 Introduction 75\u003c\/p\u003e \u003cp\u003e5.2 Biological Activity 76\u003c\/p\u003e \u003cp\u003e5.3 Chitosan's Usefulness in Therapy and Alternative Medicine 82\u003c\/p\u003e \u003cp\u003e5.4 Conclusions and Future Perspectives 84\u003c\/p\u003e \u003cp\u003e\u003cb\u003e6 Biological, Chemical, and Physical Compatibility of Chitosan and Biopharmaceuticals 93\u003c\/b\u003e\u003cbr\u003e \u003ci\u003eMasayuki Ishihara, Masanori Fujita, Satoko Kishimoto, Hidemi Hattori, and Yasuhiro Kanatani\u003c\/i\u003e\u003c\/p\u003e \u003cp\u003e6.1 Introduction 93\u003c\/p\u003e \u003cp\u003e6.2 Structural Features of Chitosan and Its Derivatives 94\u003c\/p\u003e \u003cp\u003e6.3 Biocompatibility for Chitosan and Its Derivatives 95\u003c\/p\u003e \u003cp\u003e6.4 Biocompatibility of Photo-Cross-Linkable Chitosan Hydrogel 98\u003c\/p\u003e \u003cp\u003e6.5 Physical and Chemical Compatibility of Chitosan and Its Derivatives 100\u003c\/p\u003e \u003cp\u003e6.6 Conclusions and Future Perspectives 102\u003c\/p\u003e \u003cp\u003e\u003cb\u003e7 Approaches for Functional Modification or Cross-Linking of Chitosan 107\u003c\/b\u003e\u003cbr\u003e \u003ci\u003eA. Anitha, N. Sanoj Rejinold, Joel D. Bumgardner, Shanti V. Nair, and Rangasamy Jayakumar\u003c\/i\u003e\u003c\/p\u003e \u003cp\u003e7.1 Introduction 107\u003c\/p\u003e \u003cp\u003e7.2 General Awareness of Chitosan Cross-Linking Methods 108\u003c\/p\u003e \u003cp\u003e7.3 Modified Chitosan: Synthesis and Characterization 112\u003c\/p\u003e \u003cp\u003e7.4 Applications of Modified Chitosan and Its Derivatives in Drug Delivery 118\u003c\/p\u003e \u003cp\u003e7.5 Conclusions and Future Perspectives 118\u003c\/p\u003e \u003cp\u003e\u003cb\u003ePart Two Biopharmaceuticals Formulation and Delivery Aspects Using Chitosan and Derivatives 125\u003c\/b\u003e\u003c\/p\u003e \u003cp\u003e\u003cb\u003e8 Use of Chitosan and Derivatives in Conventional Biopharmaceutical Dosage Forms Formulation 127\u003c\/b\u003e\u003cbr\u003e \u003ci\u003eTeofilo Vasconcelos, Pedro Barrocas, and Rui Cerdeira\u003c\/i\u003e\u003c\/p\u003e \u003cp\u003e8.1 Introduction 127\u003c\/p\u003e \u003cp\u003e8.2 Advantageous Properties of Chitosan and Its Derivatives 128\u003c\/p\u003e \u003cp\u003e8.3 Oral Administration 129\u003c\/p\u003e \u003cp\u003e8.4 Buccal Administration 131\u003c\/p\u003e \u003cp\u003e8.5 Nasal Administration 132\u003c\/p\u003e \u003cp\u003e8.6 Pulmonary Administration 132\u003c\/p\u003e \u003cp\u003e8.7 Transdermal Administration 133\u003c\/p\u003e \u003cp\u003e8.8 Conclusions and Future Perspectives 133\u003c\/p\u003e \u003cp\u003e\u003cb\u003e9 Manufacture Techniques of Chitosan-Based Microparticles and Nanoparticles for Biopharmaceuticals 137\u003c\/b\u003e\u003cbr\u003e \u003ci\u003eFranca Ferrari, M. Cristina Bonferoni, Silvia Rossi, Giuseppina Sandri, and Carla M. Caramella\u003c\/i\u003e\u003c\/p\u003e \u003cp\u003e9.1 Introduction 137\u003c\/p\u003e \u003cp\u003e9.2 Water-in-Oil Emulsion and Chemical Cross-linking 138\u003c\/p\u003e \u003cp\u003e9.3 Drying Techniques 141\u003c\/p\u003e \u003cp\u003e9.4 Ionic Cross-linking Methods 144\u003c\/p\u003e \u003cp\u003e9.5 Coacervation and Precipitation Method 151\u003c\/p\u003e \u003cp\u003e9.6 Direct Interaction between Chitosan and Biopharmaceuticals 152\u003c\/p\u003e \u003cp\u003e9.7 Conclusions and Future Perspectives 153\u003c\/p\u003e \u003cp\u003e\u003cb\u003e10 Chitosan and Derivatives for Biopharmaceutical Use: Mucoadhesive Properties 159\u003c\/b\u003e\u003cbr\u003e \u003ci\u003eKatharina Leithner and Andreas Bernkop-Schnurch\u003c\/i\u003e\u003c\/p\u003e \u003cp\u003e10.1 Introduction 159\u003c\/p\u003e \u003cp\u003e10.2 Mucoadhesion 160\u003c\/p\u003e \u003cp\u003e10.3 Chitosan and Its Derivatives 161\u003c\/p\u003e \u003cp\u003e10.4 Biopharmaceutical Use of Chitosan and Its Derivatives 171\u003c\/p\u003e \u003cp\u003e10.5 Conclusions and Future Perspectives 175\u003c\/p\u003e \u003cp\u003e\u003cb\u003e11 Chitosan-Based Systems for Mucosal Delivery of Biopharmaceuticals 181\u003c\/b\u003e\u003cbr\u003e \u003ci\u003eSonia Al-Qadi, Ana Grenha, and Carmen Remunan-Lopez\u003c\/i\u003e\u003c\/p\u003e \u003cp\u003e11.1 Introduction 181\u003c\/p\u003e \u003cp\u003e11.2 Important Challenges for the Delivery of Biopharmaceuticals by Mucosal Routes 182\u003c\/p\u003e \u003cp\u003e11.3 Interest in Chitosan for Mucosal Delivery of Biopharmaceuticals 184\u003c\/p\u003e \u003cp\u003e11.4 Chitosan-Based Delivery Nanosystems for Mucosal Delivery of Biopharmaceuticals 188\u003c\/p\u003e \u003cp\u003e11.5 Conclusions and Future Perspectives 200\u003c\/p\u003e \u003cp\u003e\u003cb\u003e12 Chitosan-Based Delivery Systems for Mucosal Vaccination 211\u003c\/b\u003e\u003cbr\u003e \u003ci\u003eGerrit Borchard, Farnaz Esmaeili, and Simon Heuking\u003c\/i\u003e\u003c\/p\u003e \u003cp\u003e12.1 Introduction 211\u003c\/p\u003e \u003cp\u003e12.2 Adjuvant Properties of Chitosan 212\u003c\/p\u003e \u003cp\u003e12.3 Chitosan in the Delivery of Protein and Subunit Vaccines 213\u003c\/p\u003e \u003cp\u003e12.4 Chitosan-Based Formulations of DNAVaccines 215\u003c\/p\u003e \u003cp\u003e12.5 Vaccine Formulations Using Chitosan in Combination with Other Polymers 216\u003c\/p\u003e \u003cp\u003e12.6 Chitosan Derivatives in Vaccine Carrier Design 217\u003c\/p\u003e \u003cp\u003e12.7 Conclusions and Future Perspectives 220\u003c\/p\u003e \u003cp\u003e\u003cb\u003e13 Chitosan-Based Nanoparticulates for Oral Delivery of Biopharmaceuticals 225\u003c\/b\u003e\u003cbr\u003e \u003ci\u003eFilipa Antunes, Fernanda Andrade, and Bruno Sarmento\u003c\/i\u003e\u003c\/p\u003e \u003cp\u003e13.1 Introduction 225\u003c\/p\u003e \u003cp\u003e13.2 Challenges on the Oral Delivery of Therapeutic Proteins 226\u003c\/p\u003e \u003cp\u003e13.3 Challenges on the Oral Delivery of Genetic Material 227\u003c\/p\u003e \u003cp\u003e13.4 Role of Chitosan in the Protection of Biopharmaceuticals in the Gastrointestinal Tract 229\u003c\/p\u003e \u003cp\u003e13.5 Chitosan-Based Nanoparticles for Oral Delivery of Therapeutic Proteins 232\u003c\/p\u003e \u003cp\u003e13.6 Chitosan-Based Nanoparticles for Oral Delivery of Genetic Material 234\u003c\/p\u003e \u003cp\u003e13.7 Conclusions and Future Perspectives 236\u003c\/p\u003e \u003cp\u003e\u003cb\u003e14 Chitosan-Based Systems for Ocular Delivery of Biopharmaceuticals 243\u003c\/b\u003e\u003cbr\u003e \u003ci\u003eSuresh P. Vyas, Rishi Paliwal, and Shivani Rai Paliwal\u003c\/i\u003e\u003c\/p\u003e \u003cp\u003e14.1 Introduction 243\u003c\/p\u003e \u003cp\u003e14.2 Ocular Delivery of Biopharmaceuticals 244\u003c\/p\u003e \u003cp\u003e14.3 Chitosan: A Suitable Biomaterial for Ocular Therapeutics 244\u003c\/p\u003e \u003cp\u003e14.4 Chitosan-Based Systems for Ocular Delivery of Biomacromolecules 245\u003c\/p\u003e \u003cp\u003e14.5 Toxicological and Compatibility Aspects of Chitosan-Based Ocular Systems 249\u003c\/p\u003e \u003cp\u003e14.6 Conclusions and Future Perspectives 250\u003c\/p\u003e \u003cp\u003e\u003cb\u003e15 Chemical Modification of Chitosan for Delivery of DNA and siRNA 255\u003c\/b\u003e\u003cbr\u003e \u003ci\u003eYou-Kyoung Kim, Hu-Lin Jiang, Ding-Ding Guo, Yun-Jaie Choi, Myung-Haing Cho, Toshihiro Akaike, and Chong-Su Cho\u003c\/i\u003e\u003c\/p\u003e \u003cp\u003e15.1 Introduction 255\u003c\/p\u003e \u003cp\u003e15.2 Hydrophilic Modification 256\u003c\/p\u003e \u003cp\u003e15.3 Hydrophobic Modification 257\u003c\/p\u003e \u003cp\u003e15.4 Specific Ligand Modification 259\u003c\/p\u003e \u003cp\u003e15.5 pH-Sensitive Modification 264\u003c\/p\u003e \u003cp\u003e15.6 Conclusions and Future Perspectives 269\u003c\/p\u003e \u003cp\u003e\u003cb\u003ePart Three Advanced Application of Chitosan and Derivatives for Biopharmaceuticals 275\u003c\/b\u003e\u003c\/p\u003e \u003cp\u003e\u003cb\u003e16 Target-Specific Chitosan-Based Nanoparticle Systems for Nucleic Acid Delivery 277\u003c\/b\u003e\u003cbr\u003e \u003ci\u003eShardool Jain and Mansoor Amiji\u003c\/i\u003e\u003c\/p\u003e \u003cp\u003e16.1 Introduction 277\u003c\/p\u003e \u003cp\u003e16.2 Chitosan-Based Nanoparticle Delivery Systems 283\u003c\/p\u003e \u003cp\u003e16.3 Illustrative Examples of DNAVaccine Delivery 286\u003c\/p\u003e \u003cp\u003e16.4 Illustrative Examples of Nucleic Acid Delivery Systems for Cancer Therapy 288\u003c\/p\u003e \u003cp\u003e16.5 Illustrative Examples of Nucleic Acid Delivery Systems for Anti-Inflammatory Therapy 291\u003c\/p\u003e \u003cp\u003e16.6 Conclusions and Future Perspectives 294\u003c\/p\u003e \u003cp\u003e\u003cb\u003e17 Functional PEGylated Chitosan Systems for Biopharmaceuticals 301\u003c\/b\u003e\u003cbr\u003e \u003ci\u003eHee-Jeong Cho, Goen Kim, Hyeok-Seung Kwon, and Yu-Kyoung Oh\u003c\/i\u003e\u003c\/p\u003e \u003cp\u003e17.1 Introduction 301\u003c\/p\u003e \u003cp\u003e17.2 PEGylated Chitosan for the Delivery of Proteins and Peptides 304\u003c\/p\u003e \u003cp\u003e17.3 PEGylated Chitosan for Delivery of Nucleic Acids 308\u003c\/p\u003e \u003cp\u003e17.4 PEGylated Chitosan for Delivery of Other Macromolecular Biopharmaceuticals 311\u003c\/p\u003e \u003cp\u003e17.5 PEGylated Chitosan Used for Cellular Scaffolds 313\u003c\/p\u003e \u003cp\u003e17.6 Conclusions and Future Perspectives 313\u003c\/p\u003e \u003cp\u003e\u003cb\u003e18 Stimuli-Sensitive Chitosan-Based Systems for Biopharmaceuticals 319\u003c\/b\u003e\u003cbr\u003e \u003ci\u003eCuiping Zhai, Jinfang Yuan, and Qingyu Gao\u003c\/i\u003e\u003c\/p\u003e \u003cp\u003e18.1 Introduction 319\u003c\/p\u003e \u003cp\u003e18.2 pH-Sensitive Chitosan-Based Systems 319\u003c\/p\u003e \u003cp\u003e18.3 Thermosensitive Chitosan-Based Systems 321\u003c\/p\u003e \u003cp\u003e18.4 pH-Sensitive and Thermosensitive Chitosan-Based Systems 323\u003c\/p\u003e \u003cp\u003e18.5 pH- and Ionic-Sensitive Chitosan-Based Systems 325\u003c\/p\u003e \u003cp\u003e18.6 Photo-Sensitive Chitosan-Based Systems 325\u003c\/p\u003e \u003cp\u003e18.7 Electrical-Sensitive Chitosan-Based Systems 326\u003c\/p\u003e \u003cp\u003e18.8 Magnetic-Sensitive Chitosan-Based Systems 326\u003c\/p\u003e \u003cp\u003e18.9 Chemical Substance-Sensitive Chitosan-Based Systems 327\u003c\/p\u003e \u003cp\u003e18.10 Conclusions and Future Perspectives 327\u003c\/p\u003e \u003cp\u003e\u003cb\u003e19 Chitosan Copolymers for Biopharmaceuticals 333\u003c\/b\u003e\u003cbr\u003e \u003ci\u003eRamon Novoa-Carballal, Ricardo Riguera, and Eduardo Fernandez-Megia\u003c\/i\u003e\u003c\/p\u003e \u003cp\u003e19.1 Introduction 333\u003c\/p\u003e \u003cp\u003e19.2 Chitosan-g-Poly(Ethylene Glycol) 337\u003c\/p\u003e \u003cp\u003e19.3 Chitosan-g-Polyethylenimine 347\u003c\/p\u003e \u003cp\u003e19.4 Other Copolymers of Chitosan 357\u003c\/p\u003e \u003cp\u003e19.5 Copolymers of Chitosan with Promising Applications 363\u003c\/p\u003e \u003cp\u003e19.6 Conclusions and Future Perspectives 368\u003cbr\u003e \u003c\/p\u003e \u003cp\u003e\u003cb\u003e20 Application of Chitosan for Anticancer Biopharmaceutical Delivery 381\u003c\/b\u003e\u003cbr\u003e \u003ci\u003eClaudia Philippi, Brigitta Loretz, Ulrich F. Schaefer, and Claus-Michael Lehr\u003c\/i\u003e\u003c\/p\u003e \u003cp\u003e20.1 Introduction 381\u003c\/p\u003e \u003cp\u003e20.2 Chitosan and Cancer: Intrinsic Antitumor Activity of the Polymer Itself 382\u003c\/p\u003e \u003cp\u003e20.3 Chitosan Formulations Developed for Classic Anticancer Drugs 383\u003c\/p\u003e \u003cp\u003e20.4 Biopharmaceuticals Delivered by Chitosan Preparations 384\u003c\/p\u003e \u003cp\u003e20.5 Active Targeting Strategies and Multifunctional Chitosan Formulations 388\u003c\/p\u003e \u003cp\u003e20.6 Conclusions and Future Perspectives 389\u003c\/p\u003e \u003cp\u003e\u003cb\u003e21 Chitosan-Based Biopharmaceutical Scaffolds in Tissue Engineering and Regenerative Medicine 393\u003c\/b\u003e\u003cbr\u003e \u003ci\u003eTao Jiang, Meng Deng, Wafa I. Abdel- Fattah, and Cato T. Laurencin\u003c\/i\u003e\u003c\/p\u003e \u003cp\u003e21.1 Introduction 393\u003c\/p\u003e \u003cp\u003e21.2 Fabrication of Chitosan-Based Biopharmaceuticals Scaffolds 395\u003c\/p\u003e \u003cp\u003e21.3 Applications of Chitosan-Based Biopharmaceutical Scaffolds in Tissue Engineering and Regenerative Medicine 403\u003c\/p\u003e \u003cp\u003e21.4 Future Trends: Regenerative Engineering 416\u003c\/p\u003e \u003cp\u003e21.5 Conclusions and Future Perspectives 417\u003c\/p\u003e \u003cp\u003e\u003cb\u003e22 Wound-Healing Properties of Chitosan and Its Use in Wound Dressing Biopharmaceuticals 429\u003c\/b\u003e\u003cbr\u003e \u003ci\u003eTyler G. St. Denis, Tianhong Dai, Ying-Ying Huang, and Michael R. Hamblin\u003c\/i\u003e\u003c\/p\u003e \u003cp\u003e22.1 Introduction 429\u003c\/p\u003e \u003cp\u003e22.2 Brief Review of Wound Repair 430\u003c\/p\u003e \u003cp\u003e22.3 Wound-Healing Effects of Chitosan 433\u003c\/p\u003e \u003cp\u003e22.4 Chitosan for Wound Therapeutics Delivery 440\u003c\/p\u003e \u003cp\u003e22.5 Conclusions and Future Perspectives 444\u003c\/p\u003e \u003cp\u003e\u003cb\u003ePart Four Regulatory Status, Toxicological Issues, and Clinical Perspectives 451\u003c\/b\u003e\u003c\/p\u003e \u003cp\u003e\u003cb\u003e23 Toxicological Properties of Chitosan and Derivatives for Biopharmaceutical Applications 453\u003c\/b\u003e\u003cbr\u003e \u003ci\u003eThomas J. Kean and Maya Thanou\u003c\/i\u003e\u003c\/p\u003e \u003cp\u003e23.1 Introduction 453\u003c\/p\u003e \u003cp\u003e23.2 In Vitro Toxicity of Chitosan and Derivatives 454\u003c\/p\u003e \u003cp\u003e23.3 In Vivo Toxicity of Chitosan and Derivatives 457\u003c\/p\u003e \u003cp\u003e23.4 Conclusions and Future Perspectives 459\u003cbr\u003e \u003c\/p\u003e \u003cp\u003e\u003cb\u003e24 Regulatory Status of Chitosan and Derivatives 463\u003c\/b\u003e\u003cbr\u003e \u003ci\u003eMichael Dornish, David S. Kaplan, and Sambasiva R. Arepalli\u003c\/i\u003e\u003c\/p\u003e \u003cp\u003e24.1 Introduction 463\u003c\/p\u003e \u003cp\u003e24.2 Source 464\u003c\/p\u003e \u003cp\u003e24.3 Characterization 464\u003c\/p\u003e \u003cp\u003e24.4 Purity 465\u003c\/p\u003e \u003cp\u003e24.5 Applications of Advanced Uses of Chitosan 466\u003c\/p\u003e \u003cp\u003e24.6 Regulatory Considerations for Chitosan and Chitosan Derivatives in the European Union, and Medical Devices or Combination Products with Medical Device (CDRH) Lead 468\u003c\/p\u003e \u003cp\u003e24.7 Regulatory Pathways 469\u003c\/p\u003e \u003cp\u003e24.8 Chitosan Medical Products: US Regulatory Review Processes for Medical Devices or Combination Products with CDRH Lead 469\u003c\/p\u003e \u003cp\u003e24.9 Chitosan Wound Dressings 470\u003c\/p\u003e \u003cp\u003e24.10 The European Regulatory System: The European Medicines Agency (EMA) and European Directorate for the Quality of Medicines (EDQM) 474\u003c\/p\u003e \u003cp\u003e24.11 Further Regulatory Considerations 475\u003c\/p\u003e \u003cp\u003e24.12 Conclusions and Future Perspectives 477\u003c\/p\u003e \u003cp\u003e24.13 Disclaimer 478\u003c\/p\u003e \u003cp\u003e\u003cb\u003e25 Patentability and Intellectual Property Issues Related to Chitosan-Based Biopharmaceutical Products 483\u003c\/b\u003e\u003cbr\u003e \u003ci\u003eMafalda Videira and Rogerio Gaspar\u003c\/i\u003e\u003c\/p\u003e \u003cp\u003e25.1 Introduction 483\u003c\/p\u003e \u003cp\u003e25.2 Setting the Scene: The Role of Chitosan as a Pharmaceutical Excipient 484\u003c\/p\u003e \u003cp\u003e25.3 Addressing the Drivers for Scientific Progress on Chitosan: Innovation and Inventability 495\u003c\/p\u003e \u003cp\u003e25.4 Conclusions and Future Perspectives 496\u003c\/p\u003e \u003cp\u003e\u003cb\u003e26 Quality Control and Good Manufacturing Practice (GMP) for Chitosan-Based Biopharmaceutical Products 503\u003c\/b\u003e\u003cbr\u003e \u003ci\u003eTorsten Richter, Maika Gulich, and Katja Richter\u003c\/i\u003e\u003c\/p\u003e \u003cp\u003e26.1 Introduction 504\u003c\/p\u003e \u003cp\u003e26.2 Regulatory Requirements for Production 505\u003c\/p\u003e \u003cp\u003e26.3 Manufacturing GMP: Fundamental Considerations 508\u003c\/p\u003e \u003cp\u003e26.4 Requirements for Rooms, Personnel, and Equipment 511\u003c\/p\u003e \u003cp\u003e26.5 Qualification and Validation 511\u003c\/p\u003e \u003cp\u003e26.6 Quality Control 513\u003c\/p\u003e \u003cp\u003e26.7 Monitoring and Maintenance of a GMP System 519\u003c\/p\u003e \u003cp\u003e26.8 Conclusions and Future Perspectives 522\u003c\/p\u003e \u003cp\u003e\u003cb\u003e27 Preclinical and Clinical Use of Chitosan and Derivatives for Biopharmaceuticals: From Preclinical Research to the Bedside 525\u003c\/b\u003e\u003cbr\u003e \u003ci\u003eDavid A. Zaharoff, Michael Heffernan, Jonathan Fallon, and John W. Greiner\u003c\/i\u003e\u003c\/p\u003e \u003cp\u003e27.1 Introduction 525\u003c\/p\u003e \u003cp\u003e27.2 Chitosan as a Parenteral (Subcutaneous) Vaccine Platform 526\u003c\/p\u003e \u003cp\u003e27.3 Chitosan as an Immunotherapeutic Platform 530\u003c\/p\u003e \u003cp\u003e27.4 Conclusions and Future Perspectives 537\u003c\/p\u003e \u003cp\u003eReferences 539\u003c\/p\u003e \u003cp\u003eIndex 543\u003c\/p\u003e","brand":"John Wiley \u0026 Sons Inc","offers":[{"title":"Default Title","offer_id":49525399159127,"sku":"9780470978320","price":146.25,"currency_code":"GBP","in_stock":true}],"thumbnail_url":"\/\/cdn.shopify.com\/s\/files\/1\/0817\/1739\/5799\/files\/9780470978320.jpg?v=1731860363","url":"https:\/\/bookcurl.com\/products\/chitosanbased-systems-for-biopharmaceuticals-9780470978320","provider":"Book Curl","version":"1.0","type":"link"}