Development of biopharmaceutical drug-device products. (2020)

• Record Type: Book
• Further Information: Note: Feroz Jameel, John W. Skoug, Robert R. Nesbitt, editors.
• Other Names: Jameel, Feroz; Skoug, John W; Nesbitt, Robert R
• Contents: Foreword -- Preface -- Introduction -- Section I Background of Structure and Function of Engineered Antibiodies -- Monoclonal Antibodies -- Antibody Drug Conjugates (ADCs), DVDs, BiTES (Bispecfic T Cell Engagers) -- Section II Early Stage Analytical, Molecular Assessment and Formulation. -- Leveraging the Multi-Attribute Method (MAM) to Improve Biotherapeutic Characterization -- Addressing Product Heterogenetity in ADC Biotherapeutics: Case Studies -- Cutting-Edge Analytical and Structural Methods for Characterization of ADCs.Cutting edge LC and CE-MS Methods for mABs, ACDs, and Bispecfic Antibodies -- Incorporation of Developability, Manufacturability in Therapeutic Antibody Discovery -- Analytical Characterization of Biologics for Candidate Selection and Optimization: Strategies and Case Studies -- Developability Assessment of Bispecific Antibodies: Analytical Platform and Stability Studies -- Method Development and Qualification and Molecular Assessment -- Screening for Drug-like properties of DVDs/ADCs -- Solubility and Early Assessment of Stability for Protein Therapeutics (In general and with specific case studies with modalities Duobody) -- Screening Antibody Candidates (mAbs) for Manufacturability, Stability, and Deliverability -- Practical Considerations in Screening Excipients for Protein Drugs -- Highly-Automated Procedures for the Assessment of Protein Formulations -- Formulation Design for Biologics in the Age of Lab Automation and Biological Performance Screening -- Pushing Formulation Development into Discovery through Antibody Design and High-Throughput Screening -- An Empirical Phase Diagram/ High Throughput Screening Approach to the Characterization and Formulation of Biopharmaceuticals -- Development of a combination drug product for high protein concentration mAbs: Preformulation, formulation and device -- A case study with delivery system -- Formulation and Process development of ADC Drug Products -A Case Study -- Formulation and Device Development Strategies for Fusion Protein, A case study -- Development of a combination drug product for BITEs: Pre-formulation, Analytics, formulation and device -- A case study -- Challenges in the Development of Pre-filled Syringes with Device for Biologics from a Formulation and device Points of View -- Section III Process Development -- Scale Down Models for Robust Biologics Drug Product Development -- Engineered antibodies -Understanding Intricacies of Formulation and Freeze Thaw Process -- Development and Scale-up of a Commercial Filtration Process -- Filling of High-Concentration Monoclonal Antibody Formulations: Investigating Underlying Mechanisms Impacting Precision of Low Volume Fill by Peristaltic Pump -- Development and Optimization of Freeze drying Process for Engineered antibodies -- Case studies -- Section IV Drug Delivery and Device Development -- Considerations for developing a Biologic in a PFS -- Early Device and Container Closure System Evaluation -- A case study for Cartridge -- Prefilled Syringe Technologies for Improving Drug Stability and Reliable Plunger Performance for Auto-Injectors Applications -- Global Market Trends for Advanced Combination Products -How Innovations can Contribute to Better Patient Outcomes -- Patient Centricity and System Integration as New Drivers of Biologic Drug Product Design Strategy -- Drug Delivery and Device Development, . A case study -- Development of a Combination Product : A Case Study -- Development Activities Associated with a One-Way Label Reference for a Device for Clinical Use -- Infusion set compatibility and drug delivery challenges of high potency ADCs -- Glossary -- Index. .
• Publisher Details: Cham : Springer
• Publication Date: 2020
• Extent: 1 online resource (888 pages)
• Subjects: 615/.6; Drug delivery systems; Drug development; Drug delivery systems; Drug development; Electronic books
• Languages: English
• ISBNs: 9783030314156; 3030314154; 9783030314163; 3030314162; 9783030314170; 3030314170
• Related ISBNs: 9783030314149; 3030314146
• Notes: Note: Print version record.
• 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.