Jenny Gattari , business development lead at Pfizer CentreOne , explores the advancements and challenges in monoclonal antibody production
Balancing therapeutic promise with manufacturing complexity in mAb production
Jenny Gattari , business development lead at Pfizer CentreOne , explores the advancements and challenges in monoclonal antibody production
Since the approval of the first monoclonal antibody ( mAb ) therapeutic in 1986 , mAbs have continued to revolutionise the biopharmaceutical industry and improve the lives of patients around the world . 1 These therapeutics have transformed the treatment landscape for a wide range of diseases , including cancers , haematological disorders , immune-related conditions and infectious diseases . 2 The global mAb market reflects the significant impact and potential of these therapies , being valued at $ 201.6 billion in 2022 and projected to reach $ 234.64 billion by 2032.3
The growing demand for mAbs is fuelled by their remarkable therapeutic potential , stemming from their high specificity and adaptability for various purposes . While early mAbs faced limitations due to their mouse origins , developers have made significant advances in antibody engineering , creating chimeric , humanised and fully human antibodies . 4 These advances have expanded therapeutic applications , improved treatment outcomes and minimised the risk of immune reactions .
To meet increasing global need , manufacturers have needed to focus not only on advancing antibody engineering but also enhancing the efficiency and scalability of their production . They will also need to align with increasingly stringent regulatory requirements and adapt to meet the needs of complex antibody therapies entering the market , such as bispecific antibodies ( BsAbs ) and antibody-drug conjugates ( ADCs ).
Revolutions in mAb production
Developers and manufacturers are increasingly adopting innovative approaches focusing on enhancing efficiency , reducing costs and accelerating timelines to meet the rising global demand for mAbs . These trending advances encompass a range of strategies , including implementing novel technologies , transitioning to continuous processing and integrating single-use systems .
Several key technologies have been central in enabling antibody therapeutic developers and manufacturers to meet growing demand . One is the evolution of chromatography resins for downstream processing . Protein A chromatography , a widely used method for mAb purification , has seen annual productivity and capacity increases of 4.3 % and 5.5 %, respectively , since 1978.5
Microfiltration systems are commonly employed in cell harvesting
16 SPECIALITY CHEMICALS MAGAZINE ESTABLISHED 1981