Monoclonal Antibodies: Addressing Challenges in Product Development

Monoclonal Antibodies (MAbs) are currently the primary class of protein biotherapeutics being developed by biotechnology and pharmaceutical companies. In the book "Monoclonal Antibodies," the challenges and issues surrounding the development of MAbs produced through recombinant DNA technology into therapeutic agents are discussed. The book covers downstream processing, which includes designing processes for manufacturing formulations, formulation design, filling, finishing, closure systems, and routes of administration.

Characterizing the final drug product is essential, using biophysical methods combined with genetic engineering to understand the solution properties of the formulation. This is particularly crucial for indications such as arthritis and asthma that require formulations for subcutaneous delivery (SC). Developing formulations for intravenous (IV) delivery also presents its own set of challenges, which are addressed in the book.

The book covers the challenges and strategies to overcome limitations, starting with an introduction to these issues and followed by detailed strategies in subsequent chapters. Further chapters explore the processing and storage of MAbs, the development of delivery device technologies, and conclude with a chapter on the future of MAbs in therapeutic remedies.

The book also discusses the challenges in developing MAbs for IV and SC delivery, presents strategies to tackle the challenges in the development of MAbs for both administration routes, and explores the use of biophysical analytical tools combined with MAb engineering to understand the properties of MAbs at high concentrations.

Overall, "Monoclonal Antibodies" provides a comprehensive overview of the development, processing, and future prospects of MAbs in therapeutic applications. It is a valuable resource for researchers, scientists, and professionals in the biotechnology and pharmaceutical industries.

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