Enhancing Drug Delivery of 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 requiring parenteral administration are particularly under scrutiny, given the complex and invasive nature of their dosing procedures. The COVID-19 pandemic has further underscored the value of drug delivery technologies in enabling flexible care settings, allowing patients and caregivers to choose the most suitable location for drug administration based on individual needs and capabilities.

Formulation and Device Lifecycle Management of Biotherapeutics is a seminal work that delves into the various aspects of improving drug delivery for biological medicines. Its primary goal is to reduce the dosing complexity associated with parenteral administration, thereby enhancing patient experience and healthcare capacity. This book serves as a valuable resource for multidisciplinary researchers and drug developers in the pharmaceutical industry, biotech companies, and academia who are involved in formulation and device development.

The book’s target audience includes pharmacology and medical experts responsible for generating nonclinical and clinical data to support the approval of novel dosing regimens, as well as drug delivery scientists and engineers tasked with the technical particulars of product optimizations. Furthermore, professionals in market access and commercial functions will find the discussions on the impact of patient and healthcare provider needs, along with country-specific reimbursement models, to be particularly insightful in realizing a convenient, cost-effective, and resource-efficient drug delivery solution.

Formulation and Device Lifecycle Management of Biotherapeutics provides a comprehensive overview of the following key topics:

• Summarizes formulation and device lifecycle management activities that enable customer-centric and sustainable drug delivery for biotherapeutics.
• Describes the pharmacokinetic-based clinical development pathway for subcutaneous dosing alternatives to established intravenous formulations for monoclonal antibodies.
• Details established clinical development pathways supporting the approval of automated subcutaneous injection devices and proposes novel concepts.
• Discusses how to realize home- and self-administration of biotherapeutics in cancer care.
• Highlights aspects of multidisciplinary formulation and device lifecycle management that can be leveraged across different disease areas and introduces a decision architecture on when and how drug developers should embark into related development activities.

This book is an indispensable guide for anyone involved in the development and implementation of drug delivery technologies. It offers a wealth of knowledge and insights that can help improve patient outcomes, reduce healthcare costs, and enhance the overall efficiency of drug administration processes.

Formulation and Device Lifecycle Management of Biotherapeutics is now available for purchase. For more information, please visit the publisher’s website.