Optimizing Drug Delivery for Biotherapeutics: A Comprehensive Guide

As the pressure on healthcare costs and resources continues to mount, the importance of efficient medical management cannot be overstated. Biopharmaceuticals that require parenteral administration are particularly under scrutiny, given the complex and invasive nature of the dosing procedure. The COVID-19 pandemic has further underscored the value of drug delivery technologies in enabling flexible care settings, allowing patients and their caregivers to choose the place of drug administration based on individual preferences and capabilities.

Formulation and Device Lifecycle Management of Biotherapeutics is a seminal work that addresses the various aspects of improving drug delivery of biological medicines. The primary goal is to reduce dosing complexity associated with parenteral administration, thereby enhancing patient experience and drug administration-related healthcare capacity. This comprehensive guide is aimed at multidisciplinary researchers and drug developers in the pharmaceutical industry, biotech companies, and academia involved in formulation and device development.

The book covers a wide range of topics, including:

• Pharmacology and Medical Expertise: The generation of nonclinical and clinical data to support approval of novel dosing regimens.
• Drug Delivery Science and Engineering: Technical particulars of product optimizations aimed at improving drug delivery.
• Market Access and Commercial Functions: The impact of patient and healthcare provider needs and country-specific reimbursement models on realizing a truly convenient and cost and resource efficient drug delivery solution.

Formulation and Device Lifecycle Management of Biotherapeutics provides a detailed roadmap for the development of customer-centric and sustainable drug delivery solutions for biotherapeutics. It describes the pharmacokinetic-based clinical development pathway for subcutaneous dosing alternatives to established intravenous formulations for monoclonal antibodies, and details established clinical development pathways supporting the approval of automated subcutaneous injection devices. Moreover, it proposes novel concepts for realizing home- and self-administration of biotherapeutics in cancer care, and highlights aspects of multidisciplinary formulation and device lifecycle management that can be leveraged across different disease areas.

This book is an indispensable resource for professionals in the pharmaceutical industry, biotech companies, and academia seeking to improve drug delivery for biotherapeutics. It offers a comprehensive understanding of the complex interplay between formulation, device development, and clinical outcomes, and provides actionable insights for researchers and drug developers working to create more efficient and patient-friendly drug delivery solutions.