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001 ocn908145774
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005 20190328114811.0
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007 cr cnu|||unuuu
008 150429t20152015ne a ob 001 0 eng d
040 _aN$T
_beng
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019 _a908513516
_a1066445011
020 _a9780081002971
_q(electronic bk.)
020 _a0081002971
_q(electronic bk.)
020 _z9780081002964
020 _z0081002963
035 _a(OCoLC)908145774
_z(OCoLC)908513516
_z(OCoLC)1066445011
050 4 _aQR186.85
060 0 0 _a2015 F-751
060 1 0 _aQW 575.5.A6
072 7 _aHEA
_x039000
_2bisacsh
072 7 _aMED
_x014000
_2bisacsh
072 7 _aMED
_x022000
_2bisacsh
072 7 _aMED
_x112000
_2bisacsh
072 7 _aMED
_x045000
_2bisacsh
082 0 4 _a616.07/98
100 1 _aShire, Steven J.,
_eauthor.
245 1 0 _aMonoclonal antibodies : meeting the challenges in manufacturing, formulation, delivery and stability of final drug product /
_h[electronic resource]
_cSteven J. Shire.
264 1 _aAmsterdam :
_bWoodhead Publishing is an imprint of Elsevier,
_c2015
264 4 _c�2015
300 _a1 online resource :
_billustrations (some color).
336 _atext
_btxt
_2rdacontent
337 _acomputer
_bc
_2rdamedia
338 _aonline resource
_bcr
_2rdacarrier
490 1 _aWoodhead publishing series in biomedicine ;
_vno. 77
504 _aIncludes bibliographical references and index.
588 0 _aOnline resource; title from PDF title page (EBSCO, viewed May 4, 2015).
505 0 _aFront Cover; Related titles; Monoclonal Antibodies; Copyright; Contents; List of figures; List of tables; About the author; Preface; 1 -- Introduction; Pharmaceutical development; Development of the API; mAbs as protein therapeutics; Brief review of mAb structure; References; 2 -- Analytical tools used in the formulation and assessment of stability of monoclonal antibodies (mAbs); Analytical methods for evaluation of monoclonal antibody stability; References; 3 -- Stability of monoclonal antibodies (mAbs); Degradation routes in monoclonal antibodies; Chemical degradation; Mechanisms of oxidation.
505 8 _aNonenzymatic peptide fragmentationNonreducible cross-linking in mAbs; Physical degradation; Exposure to air/water interfaces due to agitation; Use of large-scale pumps in DP unit operations; Filtration; Filling; Adsorption to surfaces; References; 4 -- Formulation of proteins and monoclonal antibodies (mAbs); Formulation of monoclonal antibodies; Buffers for pH control; Ionic strength and tonicity modifiers; Surfactants and surface-active agents; Antioxidants; Protein Stabilizers; References; 5 -- Challenges in the intravenous (IV) administration of monoclonal antibodies (mAbs).
505 8 _aExtractables and leachables from IV bags and impact on protein/mAb stabilityReferences; 6 -- Challenges in the subcutaneous (SC) administration of monoclonal antibodies (mAbs); The challenge of formulating at high concentration; Impact on delivery due to high viscosity at high mAb concentrations; Impact on manufacturing of high-concentration SC formulations due to high viscosity; Bioavailability of a high-concentration mAb formulation for SC delivery; Development of analytical tools for high-concentration formulation development; References.
505 8 _a7 -- Strategies to deal with challenges of developing high-concentration subcutaneous (SC) formulations for monoclonal antibodies (mAbs)Using existing manufacturing technologies through redesign of equipment or modification of process variables to produce high-con ... ; Development of alternative processes/formulations for manufacturing of high-concentration dosage forms; Using formulation excipients to reduce viscosity; References; 8 -- Development of delivery device technology to deal with the challenges of highly viscous mAb formulations at high concentration.
505 8 _aUsing delivery devices to deliver large volume mAb formulations by the subcutaneous routeDelivery of viscous solutions using a prefilled syringe; The technical challenges for device and formulation development; Primary container/closure systems for devices to be used with mAbs; Silicone oil interactions with proteins and mAbs in prefilled syringes; Impact of leachables from prefilled syringe components; Potential interactions with stainless steel needles; Potential problems with tungsten in prefilled syringes; Filling of highly concentrated mAbs into prefilled syringes; References.
505 8 _a9 -- The molecular basis of high viscosity of monoclonal antibodies (mAbs) at high concentration.
520 _aMonoclonal antibodies (MAbs) are currently the major class of protein bio therapeutic being developed by biotechnology and pharmaceutical companies. Monoclonal Antibodies discusses the challenges and issues revolving around development of a monoclonal antibody produced by recombinant DNA technology into a therapeutic agent. This book covers downstream processing which includes design of processes to manufacture the formulation, formulation design, fill and finish into closure systems and routes of administration. The characterization of the final drug product is covered where the use of biophy.
650 0 _aMonoclonal antibodies.
650 7 _aHEALTH & FITNESS
_xDiseases
_xGeneral.
_2bisacsh
650 7 _aMEDICAL
_xClinical Medicine.
_2bisacsh
650 7 _aMEDICAL
_xDiseases.
_2bisacsh
650 7 _aMEDICAL
_xEvidence-Based Medicine.
_2bisacsh
650 7 _aMEDICAL
_xInternal Medicine.
_2bisacsh
650 7 _aMonoclonal antibodies.
_2fast
_0(OCoLC)fst01025547
650 1 2 _aAntibodies, Monoclonal
_xtherapeutic use.
_0(DNLM)D000911Q000627
650 2 2 _aTechnology, Pharmaceutical.
_0(DNLM)D013678
655 4 _aElectronic books.
655 0 _aElectronic book.
776 0 8 _iPrint version:
_aShire, Steven.
_tMonoclonal Antibodies : Meeting the Challenges in Manufacturing, Formulation, Delivery and Stability of Final Drug Product.
_dBurlington : Elsevier Science, �2015
_z9780081002964
830 0 _aWoodhead Publishing series in biomedicine ;
_vno. 77.
856 4 0 _3ScienceDirect
_uhttp://www.sciencedirect.com/science/book/9780081002964
999 _c247079
_d247079