The Resource Challenges in Protein Product Development, edited by Nicholas W. Warne, Hanns-Christian Mahler, (electronic resource)

Challenges in Protein Product Development, edited by Nicholas W. Warne, Hanns-Christian Mahler, (electronic resource)

Label
Challenges in Protein Product Development
Title
Challenges in Protein Product Development
Statement of responsibility
edited by Nicholas W. Warne, Hanns-Christian Mahler
Contributor
Editor
Provider
Subject
Language
eng
Summary
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
Member of
Image bit depth
0
LC call number
  • RS380
  • RS190-210
Literary form
non fiction
http://library.link/vocab/relatedWorkOrContributorName
  • Warne, Nicholas W.
  • Mahler, Hanns-Christian.
  • SpringerLink
Series statement
AAPS Advances in the Pharmaceutical Sciences Series,
Series volume
38
http://library.link/vocab/subjectName
  • Medicine
  • Pharmaceutical technology
  • Biomedicine
  • Pharmaceutical Sciences/Technology
Label
Challenges in Protein Product Development, edited by Nicholas W. Warne, Hanns-Christian Mahler, (electronic resource)
Instantiates
Publication
Antecedent source
mixed
Carrier category
online resource
Carrier category code
cr
Carrier MARC source
rdacarrier
Color
not applicable
Content category
text
Content type code
txt
Content type MARC source
rdacontent
Contents
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
Dimensions
unknown
Extent
XVI, 599 p. 130 illus., 75 illus. in color.
File format
multiple file formats
Form of item
electronic
Isbn
9783319906034
Level of compression
uncompressed
Media category
computer
Media MARC source
rdamedia
Media type code
c
Other control number
10.1007/978-3-319-90603-4
Other physical details
online resource.
Quality assurance targets
absent
Reformatting quality
access
Specific material designation
remote
System control number
(DE-He213)978-3-319-90603-4
Label
Challenges in Protein Product Development, edited by Nicholas W. Warne, Hanns-Christian Mahler, (electronic resource)
Publication
Antecedent source
mixed
Carrier category
online resource
Carrier category code
cr
Carrier MARC source
rdacarrier
Color
not applicable
Content category
text
Content type code
txt
Content type MARC source
rdacontent
Contents
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
Dimensions
unknown
Extent
XVI, 599 p. 130 illus., 75 illus. in color.
File format
multiple file formats
Form of item
electronic
Isbn
9783319906034
Level of compression
uncompressed
Media category
computer
Media MARC source
rdamedia
Media type code
c
Other control number
10.1007/978-3-319-90603-4
Other physical details
online resource.
Quality assurance targets
absent
Reformatting quality
access
Specific material designation
remote
System control number
(DE-He213)978-3-319-90603-4

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