Monoclonal Antibodies - From Concept to Approval

At the end of this course, participants will have a comprehensive understanding of monoclonal antibodies (mAbs). From the early development process, through upstream and downstream manufacturing, to different analytical approaches, clinical trials and stability studies. The course is designed to ensure that participants not only understand the theoretical underpinnings of mAb development, but also the practical and regulatory challenges that must be overcome to bring a therapeutic antibody from the laboratory to the clinic and ultimately to the market.

Background

Monoclonal antibodies (mAbs) are increasingly becoming a cornerstone of therapeutic strategies in a wide range of diseases, including oncology, rheumatology and infectious diseases. Their ability to target specific antigens with high precision makes them critical tools in the fight against complex diseases. The global market for monoclonal antibodies is expanding not only because of their efficacy but also because of technological advances in genetic engineering and bioprocessing.

The development of monoclonal antibodies involves a sophisticated and multidisciplinary approach that integrates the fields of molecular biology, genetic engineering, immunology and pharmacology. The complexity of the development process is compounded by the stringent requirements imposed by regulatory authorities to ensure the safety, efficacy and quality of these biopharmaceuticals before they reach the market.

Guidelines from regulatory agencies such as the US Food and Drug Administration (FDA), the European Medicines Agency (EMA) and the International Council for Harmonization of Technical Requirements for Pharmaceuticals for Human Use (ICH) provide structured pathways and requirements for the development and approval of monoclonal antibodies. These guidelines include detailed criteria for the manufacturing process, preclinical and clinical testing and submission of regulatory dossiers.

Given the rigorous and detailed nature of these guidelines, professionals involved in mAb development must have a deep understanding of both the scientific and regulatory landscape. It is essential that these professionals are familiar with critical guidelines such as ICH Q6B, which details test procedures and acceptance criteria for biotechnology and biological products, or ICH Q8(R2), which provides guidance on pharmaceutical development.