Targeted Modalities: Trends, Challenges, And CDMO Considerations In A Precision-Driven Era

Targeted drug modalities, such as antibody-drug conjugates (ADCs) and targeted protein degraders (TPDs), are changing how complex diseases are treated as the pharmaceutical industry moves towards precision therapies. 

Targeted therapies are designed to bind directly to a specific receptor in the body, typically an oncology target, but can also be used for other diseases with an antigen target. Unlike non-targeted modalities that are distributed systemically, targeted therapies go directly to their intended sites of action. A greater understanding of human genetics and advances in drug discovery have made it possible to develop therapies that deliver an active compound directly to the affected tissue or cell.

Developing these therapies comes with unique challenges in formulation, manufacturing, and regulatory pathways. Targeted therapies are often highly potent and sensitive to environmental conditions, requiring strict containment and careful handling. Since batch sizes can be small, equipment for small-scale manufacturing is required, which can lead to high costs per dose and difficulty in sourcing raw materials. Targeted therapies are often granted "breakthrough therapy" designations by regulatory bodies, which can speed up approval timelines but also puts pressure on companies to conduct robust studies quickly.

CDMOs often have the specialized infrastructure, flexibility, and expertise needed to support the development and manufacturing of targeted modalities. The field of targeted therapies is expanding beyond oncology into areas like neurology and autoimmune disorders , and the use of digital technologies like AI is accelerating their development.