000843677 000__ 06565cam\a2200541Ii\4500
000843677 001__ 843677
000843677 005__ 20230306144905.0
000843677 006__ m\\\\\o\\d\\\\\\\\
000843677 007__ cr\cn\nnnunnun
000843677 008__ 180622s2018\\\\sz\\\\\\ob\\\\001\0\eng\d
000843677 019__ $$a1042077697$$a1042353714
000843677 020__ $$a9783319906034$$q(electronic book)
000843677 020__ $$a3319906038$$q(electronic book)
000843677 020__ $$z9783319906010
000843677 020__ $$z3319906011
000843677 035__ $$aSP(OCoLC)on1041706759
000843677 035__ $$aSP(OCoLC)1041706759$$z(OCoLC)1042077697$$z(OCoLC)1042353714
000843677 040__ $$aN$T$$beng$$erda$$epn$$cN$T$$dN$T$$dGW5XE$$dYDX$$dEBLCP$$dOCLCF$$dUAB
000843677 049__ $$aISEA
000843677 050_4 $$aRS380
000843677 08204 $$a615.19$$223
000843677 24500 $$aChallenges in protein product development /$$cNicholas W. Warne, Hanns-Christian Mahler, editors.
000843677 264_1 $$aCham, Switzerland :$$bSpringer ;$$aArlington, Va. :$$bAmerican Association of Pharmaceutical Scientists,$$c[2018]
000843677 300__ $$a1 online resource.
000843677 336__ $$atext$$btxt$$2rdacontent
000843677 337__ $$acomputer$$bc$$2rdamedia
000843677 338__ $$aonline resource$$bcr$$2rdacarrier
000843677 4901_ $$aAAPS advances in the pharmaceutical sciences series ;$$vvolume 38
000843677 504__ $$aIncludes bibliographical references and index.
000843677 5050_ $$aIntro; Preface; Contents; Contributors; Abbreviations; Formulation Development of Biologics; 1 Introduction into Formulation Development of Biologics; Abstract; 1.1 Introduction; 1.2 Formulation Development Strategies and Approaches; 1.2.1 Protein Formulation: Beyond Stabilization; 1.2.2 Components of a Protein Formulation; 1.2.2.1 Active Pharmaceutical Ingredient and Drug Substance; 1.2.2.2 Excipients; 1.2.2.3 Primary Packaging Material; 1.2.3 Preformulation; 1.2.4 Formulation Development; 1.2.4.1 Formulation Development Strategies; 1.2.4.2 Early Stage Formulation Development
000843677 5058_ $$a1.2.4.3 Late-Stage Formulation Development1.2.4.4 Formulation Development After Commercialization; 1.3 Challenges During Formulation Development; 1.3.1 Amount and Quality of DS; 1.3.2 Selection of Analytical Methods and Stress Conditions; 1.3.2.1 Analytical Methods; 1.3.2.2 Stability Testing and Forced-Degradation Studies; 1.3.3 Manufacturability and Formulability; 1.3.4 Data Handling and Analysis; 1.4 Conclusions; References; Further Reading; Challenges with Excipients; 2 Polysorbate Degradation and Quality; Abstract; 2.1 Introduction; 2.2 Chemical Structure, Synthesis and Composition
000843677 5058_ $$a2.2.1 Structure Heterogeneity in PS20 and PS802.3 Use in Biotherapeutics; 2.4 Interaction of Nonionic Surfactants with Proteins; 2.5 Interactions of Protein-Surfactant Mixtures at Interfaces; 2.6 Pharmacopoeia Requirements and Commercially Available Grades of Polysorbate; 2.7 Stability and Degradation in Formulations; 2.8 Mechanistic Pathways of Polysorbate Degradation; 2.9 Hydrolysis; References; 3 Sucrose and Trehalose in Therapeutic Protein Formulations; Abstract; 3.1 Introduction; 3.2 Physical Properties; 3.2.1 Introduction; 3.2.2 Solution-State Properties; 3.2.3 Solid-State Properties
000843677 5058_ $$a3.2.4 Chemical Properties3.3 Use in Formulations and Stabilization Mechanisms; 3.3.1 Liquid State; 3.3.2 Frozen State; 3.3.3 Lyophilized State; 3.4 Regulatory and Safety Aspects; 3.4.1 Regulatory Aspects; 3.4.2 Safety Aspects; 3.5 Summary and Recommendations; References; High Concentration Proteins; 4 Introduction to High-Concentration Proteins; Abstract; 4.1 Overview of Recombinant Therapeutic Proteins; 4.1.1 Antibody Therapeutics; 4.1.2 Concentration Ranges of Marketed Biotherapeutics; 4.2 Need for High-Concentration Protein Products; 4.2.1 Routes of Administration
000843677 5058_ $$a4.2.2 High Dose Requirement4.2.3 Long-Term Drug Administration; 4.2.4 Manufacturing Cost; 4.3 Overall Challenges in Developing High-Concentration Products; 4.3.1 Theoretical Considerations; 4.3.2 Physical Properties and Influencing Factors of High-Concentration Proteins; 4.3.2.1 Solution Viscosity; 4.3.2.2 Protein Conformation; 4.3.2.3 Aggregation Tendency; 4.3.2.4 Factors Influencing Protein-Protein Interactions; 4.3.3 Major Challenges; 4.3.3.1 Formulation Development; 4.3.3.2 Process Development; 4.3.3.3 Drug Administration; 4.4 Future Directions
000843677 506__ $$aAccess limited to authorized users.
000843677 520__ $$aIn this volume, the authors discuss the many significant challenges currently faced in biotechnology dosage form development, providing guidance, shared experience and thoughtful reflection on how best to address these potential concerns. As the field of therapeutic recombinant therapeutic proteins enters its fourth decade and the market for biopharmaceuticals becomes increasingly competitive, companies are increasingly dedicating resources to develop innovative biopharmaceuticals to address unmet medical needs. Often, the pharmaceutical development scientist is encountering challenging pharmaceutical properties of a given protein or by the demands placed on the product by stability, manufacturing and preclinical or clinical expectations, as well as the evolving regulatory expectations and landscape. Further, there have been new findings that require close assessment, as for example those related to excipient quality, processing, viscosity and device compatibility and administration, solubility and opalescence and container-closure selection. The literature varies widely in its discussion of these critical elements and consensus does not exist. This topic is receiving a great deal of attention within the biotechnology industry as well as with academic researchers and regulatory agencies globally. Therefore, this book is of interest for business leaders, researchers, formulation and process development scientists, analytical scientists, QA and QC officers, regulatory staff, manufacturing leaders and regulators active in the pharmaceutical and biotech industry, and expert reviewers in regulatory agencies.
000843677 588__ $$aOnline resource; title from PDF title page (viewed June 25, 2018).
000843677 650_0 $$aPharmaceutical biotechnology.
000843677 650_0 $$aProteins$$xBiotechnology.
000843677 7001_ $$aWarne, Nicholas W.,$$eeditor.
000843677 7001_ $$aMahler, Hanns-Christian,$$eeditor.
000843677 77608 $$iPrint version: $$z3319906011$$z9783319906010$$w(OCoLC)1029891710
000843677 830_0 $$aAAPS advances in the pharmaceutical sciences series ;$$vv. 38.
000843677 852__ $$bebk
000843677 85640 $$3SpringerLink$$uhttps://univsouthin.idm.oclc.org/login?url=http://link.springer.com/10.1007/978-3-319-90603-4$$zOnline Access$$91397441.1
000843677 909CO $$ooai:library.usi.edu:843677$$pGLOBAL_SET
000843677 980__ $$aEBOOK
000843677 980__ $$aBIB
000843677 982__ $$aEbook
000843677 983__ $$aOnline
000843677 994__ $$a92$$bISE