Development of Biopharmaceutical Drug-Device Products
The biotechnology/biopharmaceutical sector has tremendously grown which led to the invention of engineered antibodies such as Antibody Drug Conjugates (ADCs), Bispecific T-cell engager (BITES), Dual Variable Domain (DVD) antibodies, and fusion proteins that are currently being used as therapeutic ag...
| Other Authors: | , , |
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| Format: | eBook |
| Language: | English |
| Published: |
Cham
Springer International Publishing
2020, 2020
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| Edition: | 1st ed. 2020 |
| Series: | AAPS Advances in the Pharmaceutical Sciences Series
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| Subjects: | |
| Online Access: | |
| Collection: | Springer eBooks 2005- - Collection details see MPG.ReNa |
Table of 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
- 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.
- 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