The complexity and diversity of antibody-based therapies have been increasing with the growing understanding of the intricate mechanisms involved in immune responses, the discovery of novel therapy targets and the development of new technologies for antibody production. As a result, the biopharmaceutical industry has placed greater significance on advancements in manufacturing and collaborations within the supply chain. However, introducing new products or materials into a pre-existing process can be time-consuming and costly, as regulatory agencies must be notified and the entire manufacturing process reapproved.
Better access to innovative purification materials is crucial for delivering new antibody therapeutics to market, and the patients who need them. To overcome regulatory hurdles and adopt new materials into current processes with greater efficiency, the biopharmaceutical industry is exploring various strategies.
In this article, Aaron Moulin, Field Application Specialist at Purolite, discusses the need to establish robust supplier networks that will support streamlining biologics development and manufacturing processes. He also explores some of the emerging purification challenges associated with developing novel antibodies, emphasizing the importance of implementing a quality-by-design (QbD) approach when adopting new resin technologies.
Finding Support Within a Robust Supplier Partnership
The ongoing challenges caused by the COVID-19 pandemic, such as labour shortages, supply chain disruptions, and increased competition have contributed to the need for manufacturers to innovate and optimise their manufacturing techniques and business practices.
A key focus for manufacturers should be ensuring supply chain resilience for bioprocess resins by sourcing multiple suppliers of key raw materials, securing domestic manufacturing capabilities, and manufacturing on multiple continents if necessary.
Downstream processing (DSP) techniques such as chromatography are used in monoclonal antibody (mAb) production to remove unwanted contaminants and to obtain a highly purified end product during purification. Manufacturers should aim to intensify their purification process by adopting processing methods that achieve sufficient speed, high throughput, and efficient use of facility space. As DSP plays a critical role in maintaining product safety, future-proofing is essential; this relies on robust supply chain networks.
It is crucial to choose products and suppliers with a proven track record in innovation to meet the ongoing demand for chromatography resins with high binding capacities and mitigate manufacturing bottlenecks in downstream purification. This way, manufacturers can ensure a bright future for mAb bioprocessing in the face of ongoing global uncertainty.
The Emergence of Novel Purification Methods
Novel antibody-based therapies are increasing in prevalence, reflected in the bispecific antibody market for cancer therapies, which is predicted to grow by over $400 million by 2027.1 With the complexity of antibody-based therapies steadily increasing, classic purification methods may no longer be viable.
Chromatography resins made of cross-linked agarose, glass, or polymer beads bound to a Protein A ligand via a linker are commonly used in mAb purification. Protein A exhibits a strong affinity for antibody-based materials and can form a complex at pH levels ranging from 5 to 8, with the bound antibody being eluted when the pH is lowered to acidic conditions. This method is generally employed in the initial stages of development and maintained throughout commercial production.