Challenges in Protein Product Development (Registro nro. 242992)

MARC details
000 -LIDER
fixed length control field 05700nam a22005415i 4500
001 - CONTROL NUMBER
control field 978-3-319-90603-4
003 - CONTROL NUMBER IDENTIFIER
control field DE-He213
005 - DATE AND TIME OF LATEST TRANSACTION
control field 20210201191408.0
007 - PHYSICAL DESCRIPTION FIXED FIELD--GENERAL INFORMATION
fixed length control field cr nn 008mamaa
008 - FIXED-LENGTH DATA ELEMENTS--GENERAL INFORMATION
fixed length control field 180620s2018 gw | s |||| 0|eng d
020 ## - INTERNATIONAL STANDARD BOOK NUMBER
International Standard Book Number 9783319906034
-- 978-3-319-90603-4
050 #4 - LIBRARY OF CONGRESS CALL NUMBER
Classification number RS380
050 #4 - LIBRARY OF CONGRESS CALL NUMBER
Classification number RS190-210
072 #7 - SUBJECT CATEGORY CODE
Subject category code TDCW
Source bicssc
072 #7 - SUBJECT CATEGORY CODE
Subject category code MED072000
Source bisacsh
072 #7 - SUBJECT CATEGORY CODE
Subject category code TDC
Source thema
082 04 - DEWEY DECIMAL CLASSIFICATION NUMBER
Classification number 615.19
Edition number 23
245 10 - TITLE STATEMENT
Title Challenges in Protein Product Development
Medium [electronic resource] /
Statement of responsibility, etc. edited by Nicholas W. Warne, Hanns-Christian Mahler.
250 ## - EDITION STATEMENT
Edition statement 1st ed. 2018.
264 #1 -
-- Cham :
-- Springer International Publishing :
-- Imprint: Springer,
-- 2018.
300 ## - PHYSICAL DESCRIPTION
Extent XVI, 599 p. 130 illus., 75 illus. in color.
Other physical details online resource.
336 ## -
-- text
-- txt
-- rdacontent
337 ## -
-- computer
-- c
-- rdamedia
338 ## -
-- online resource
-- cr
-- rdacarrier
347 ## -
-- text file
-- PDF
-- rda
490 1# - SERIES STATEMENT
Series statement AAPS Advances in the Pharmaceutical Sciences Series,
International Standard Serial Number 2210-7371 ;
Volume/sequential designation 38
500 ## - GENERAL NOTE
General note Acceso multiusuario
505 0# - FORMATTED CONTENTS NOTE
Formatted contents note Part 1. Formulation Development of Biologics -- Introduction into Formulation Development of Biologics -- Part 2. Challenges with Excipients -- Polysorbate Degradation and Quality -- Sucrose and Trehalose in Therapeutic Protein Formulations -- Part 3. High Concentration Proteins -- Introduction to High-Concentration Proteins -- Solubility, Opalescence & Particulate Matter -- Analytical Characterization and Predictive Tools for Highly Concentrated Protein Formulations -- Practical Considerations for High Concentration Protein Formulations -- Part 4. Container-Closure Systems -- Parenteral Container Closure Systems -- Development of Prefilled Syringe Combination Products for Biologics -- Special Topics in Analytics of Pre-filled Syringes -- C Mini-Pumps -- Container Closure Integrity Testing of Primary Containers for Parenteral Products -- Chemical Durability of Glass - Delamination -- Part 5. Processing Considerations -- Bulk Protein Solution: Freeze Thaw Process, Storage and Shipping Considerations -- Leachables and Extractables: From Regulatory Expectations to Laboratory Assessment -- Biotherapeutic Drug Product Manufacturing and Process Development -- Line Sterilization Considerations and VHP -- Lyophilization: Process Design, Robustness and Risk Management -- Fogging -- Scientific Approaches for the Application of QbD Principles in Lyophilization Process Development -- Manufacturing of Highly Potent Drug Product in a Clinical Multi-Product Aseptic Facility and Transfer of Principles to Antibiotic Drug Product -- Part 6. Novel Constructs -- Introduction into Novel Constructs -- Novel Constructs - Half-Life Extensions -- Fc Fusion Proteins -- Part 7. Lifecycle Management -- Lifecycle Management of Biotherapeutic Dosage Forms -- Switching from an IV to an SC Formulation - Considerations for Formulation Development and Formulation Bridging.
520 ## - SUMMARY, ETC.
Summary, etc. In 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.
541 ## - IMMEDIATE SOURCE OF ACQUISITION NOTE
Owner UABC ;
Method of acquisition Temporal ;
Date of acquisition 01/01/2021-12/31/2023.
650 #0 - SUBJECT ADDED ENTRY--TOPICAL TERM
Término temático o nombre geográfico como elemento de entrada Pharmaceutical technology.
650 14 - SUBJECT ADDED ENTRY--TOPICAL TERM
Término temático o nombre geográfico como elemento de entrada Pharmaceutical Sciences/Technology.
-- https://scigraph.springernature.com/ontologies/product-market-codes/B21010
700 1# - ADDED ENTRY--PERSONAL NAME
Personal name Warne, Nicholas W.
Relator term editor.
Relator code edt
-- http://id.loc.gov/vocabulary/relators/edt
700 1# - ADDED ENTRY--PERSONAL NAME
Personal name Mahler, Hanns-Christian.
Relator term editor.
Relator code edt
-- http://id.loc.gov/vocabulary/relators/edt
710 2# - ADDED ENTRY--CORPORATE NAME
Corporate name or jurisdiction name as entry element SpringerLink (Online service)
773 0# - HOST ITEM ENTRY
Title Springer Nature eBook
776 08 - ADDITIONAL PHYSICAL FORM ENTRY
Relationship information Printed edition:
International Standard Book Number 9783319906010
776 08 - ADDITIONAL PHYSICAL FORM ENTRY
Relationship information Printed edition:
International Standard Book Number 9783319906027
776 08 - ADDITIONAL PHYSICAL FORM ENTRY
Relationship information Printed edition:
International Standard Book Number 9783030080525
830 #0 - SERIES ADDED ENTRY--UNIFORM TITLE
Uniform title AAPS Advances in the Pharmaceutical Sciences Series,
-- 2210-7371 ;
Volume number/sequential designation 38
856 40 - ELECTRONIC LOCATION AND ACCESS
Public note Libro electrónico
Uniform Resource Identifier http://148.231.10.114:2048/login?url=https://doi.org/10.1007/978-3-319-90603-4
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-- ZDB-2-SXB
942 ## - ADDED ENTRY ELEMENTS (KOHA)
Koha item type Libro Electrónico
Existencias
Estado de retiro Colección Ubicación permanente Ubicación actual Fecha de ingreso Total Checkouts Date last seen Número de copia Tipo de material
  Colección de Libros Electrónicos Biblioteca Electrónica Biblioteca Electrónica 01/02/2021   01/02/2021 1 Libro Electrónico

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