Biosimilars and interchangeable biologics. Tactical elements / (2016)

• Record Type: Book
• Other Titles: Tactical elements
• Further Information: Note: Sarfaraz K. Niazi.
• Authors: Niazi, Sarfaraz, 1949-
• Contents: Structural and Functional Elements; Basics; Multidimensional View; Primary Structure; Secondary Structure; Tertiary Structure; Quaternary Structure; Posttranslational Modification (PTM); Protein Folding; Protein Structural Variability; Recombinant DNA; Bibliography; Immunogenicity Considerations; Introduction; Immune System; Antigens; Antibody; Protein Immunogenicity; Biosimilar Product Immunogenicity; Immunogenicity Testing; Conclusion; Bibliography; Product Development Strategies; Background; Selection of Product; Manufacturing System Selection; Cell Line Choice; Reference Product; Test Method Development; Specifications; Reverse Engineering; Analytical and Functional Similarity; Nonclinical Studies; Clinical Pharmacology Studies; Interchangeability Protocols; Regulatory Uncertainty; Legal Teams in Place; Commercialization Challenges; Bibliography; Stability and Formulation Considerations; Introduction; Formulation of Biosimilar Products; Common Formulation Elements; High Concentration Formulations; Stability Testing Guidance; Bibliography Biosimilarity Tetrahedron; Tetrahedron Concept; Similarity Concept; Comparability versus Similarity; Analytical and Functional Similarity; Analytical Instrumentation; Identity; Purity; Potency; Safety; Clinical Data; Risk-Based Critical Quality Attributes; Nonclinical Data; Stages of Analytical Similarity; Level of Similarity; Statistical Modeling of Similarity Data; Interchangeability; Conclusion; Bibliography; Recombinant Expression Systems; Background; Expression System Development; Manipulations to Improve Yield; Mammalian Cells Expression Systems; Mammalian Cell Expression Improvements; Yeast Expression Systems; Insect Cells; Transgenic Animals; Cell Banks; Bibliography; Upstream Systems Optimization ; Background; Bacterial Manufacturing Systems; Mammalian Manufacturing Systems; Yeast Cell Manufacturing Systems; Transgenic Animal Systems; Cell Lines and Characterization; Future Prospects; Bibliography; Downstream Systems Optimization; Introduction; Bacterial Downstream Processing; Mammalian Downstream; Yeast Downstream Processing; Insect Cell Processing; Transgenic Animals Processing; Bibliography; Single-Use Manufacturing Systems (SUMS); Background; Safety of Single-Use Systems; Polymers and Additives; Regulatory Requirements; Risk Assessment; Single-Use Containers; Summary; Single-Use Mixing Systems; Connectors and Transfers; Filtration; Controls; Filling and Finishing Systems; Environmental Concerns; Bibliography; Commercial Manufacturing Overview; Introduction; Media; Culture Growth; Process Overview; Process Maturity; Validation; Scale-Up; Specific Scale-Up Issues; Specific Economy Issues; Process Materials; Environment Control; Biosafety Levels; Good Manufacturing Controls of Active Pharmaceutical Ingredients; Cleaning Procedures; Processing and Filling; Laboratory Testing; Laboratory Controls; Documentation; Bibliography; Outsourcing Considerations; Background; Value of Outsourcing; Factors to Consider in Outsourcing; Key Requirements; What to Outsource?; Cell Line Suppliers; CMOs; Biopharmaceutical Support Services; Analytical Support Providers; Contract Research Organizations; Product Development Services; Fill and Finish Providers; Legal Matters; Managing Outsourcing; Outlook;
• Edition: 1st
• Publisher Details: Boca Raton : CRC Press
• Publication Date: 2016
• Extent: 1 online resource, illustrations (black and white, and colour)
• Subjects: 615.1; Pharmaceutical biotechnology; Pharmaceutical biotechnology industry; Recombinant proteins
• Languages: English
• ISBNs: 9781498743501
• Related ISBNs: 9781498743495
• Notes: Note: Includes bibliographical references and index.; Note: Description based on CIP data; item not viewed.
• Access Rights: Legal Deposit; Only available on premises controlled by the deposit library and to one user at any one time; The Legal Deposit Libraries (Non-Print Works) Regulations (UK).
• Access Usage: Restricted: Printing from this resource is governed by The Legal Deposit Libraries (Non-Print Works) Regulations (UK) and UK copyright law currently in force.