Speciality Chemicals Magazine MAY / JUN 2024 | Page 32

Tom Wilson , VP of contract manufacturing at Pfizer CentreOne , explores the role of CDMOs in complex biologics

Enhancing complex biologic production

Tom Wilson , VP of contract manufacturing at Pfizer CentreOne , explores the role of CDMOs in complex biologics

The pharmaceutical industry is witnessing a transformative era where chemistry and biologics are converging to drive innovation . The intersection of these two disciplines represents a dynamic and rapidly evolving field that holds immense potential for revolutionising drug development to help change patients ’ lives .

We are now seeing increasing numbers of complex biologics enter the development pipeline , including antibody-drug conjugates ( ADCs ), innovative vaccines , and cell and gene therapies ( CGTs ). Supporting the production of these nextgeneration medicines demands a comprehensive understanding across various scientific disciplines .
As we look to the future , harnessing the power of these and other revolutionary products will require an increasingly in-depth understanding of the interplay between biology and chemistry to further advancements in drug design , development and manufacturing .
Novel biologic modalities
Since the first monoclonal antibody ( mAb ) therapy was approved in 1986 , the biologics market has rapidly expanded . 1 In fact , the biologics market has more than doubled in value in the last ten years , growing from $ 194.4 billion in 2014 to $ 402.1 billion in 2023.2 A key driving force behind this rapid growth is the introduction of biologic modalities , such as innovative vaccines , ADCs and CGTs , into the development pipeline .
Moving beyond traditional mAb therapies and small molecule drugs , these new modalities are offering the potential for enhanced specificity , reduced off-target interactions and longer-lasting therapeutic effects in complex diseases like cancer , autoimmune disorders and genetic disorders . They are in high demand . The global CGT market alone is projected to grow from $ 15.46 billion in 2022 to reach $ 82.24 billion by 2032.3
Despite their immense potential , these products are inherently complex . Their development and manufacturing rely on experts in organic , medicinal and analytical chemistry as well as molecular and cellular biology , pharmacology and immunology , working closely together to navigate the challenges of working with relatively new therapeutic compounds .
32 SPECIALITY CHEMICALS MAGAZINE ESTABLISHED 1981