Using Recombinant Antibody Technology to increase supply chain resiliency

By Catherine Bladen, PhD, Chief Operations Officer, Absolute Antibody

Every industry has been impacted by changes in the global supply chain from the COVID-19 pandemic, including the therapeutics, diagnostics and research industries. Companies were affected by supply chain failings to varying degrees, and those with adaptable processes fared better than others. Organizations are therefore re-evaluating their operational resiliency, or their ability to quickly and flexibly adapt to external disruptions, to handle changing conditions due to future challenges.

For biotechnology and diagnostic companies, having a secure supply chain of high-quality reagents is critical for weathering unforeseen circumstances. In many cases, this means redundancy in reagent suppliers. In terms of antibodies, utilizing recombinant versions is another means to significantly mitigate risk by ensuring long-term availability and reproducibility of production.

Recombinant antibodies are manufactured using synthetic genes expressed in a defined in vitro cell line. Compared to traditional hybridoma-derived antibodies, recombinant antibodies offer a variety of benefits. Because their amino acid sequence is absolutely defined, batch-to-batch reproducibility is ensured. Recombinant antibodies may also be engineered into a variety of new formats, facilitating a wide range of experimental possibilities. Antibody engineering options include switching species, isotypes and subtypes; creating fragments and multispecifics; and developing humanized antibodies.

Sequencing enables antibodies to be manufactured recombinantly with the high batch-to-batch reproducibility. This diagram outlines Absolute Antibody’s hybridoma sequencing method.

Recombinant antibody technology has traditionally been used by therapeutic companies in their development of biologics; however, the technology at its core mitigates manufacturing risk by “digitizing” antibody assets and guaranteeing long-term reproducible production. It also increases the ability to manipulate assets for any new requirements that might arise. Implementing recombinant antibody technology therefore strengthens supply chain resiliency in three ways:

· Decreased reliance on a physical asset. As sequenced antibodies are digitized, they are no longer geographically constrained to a manufacturing facility. Should one production site shut down, manufacture can easily transition elsewhere in the world. This also holds true if the original antibody is contaminated, mutated or lost.

· Agile response by changing formats. By engineering antibodies, scientists can quickly alter formats for rapid-paced research. For example, during the COVID-19 pandemic, recombinant technology enabled rapid engineering of IgM and IgA antibodies to create highly effective and reliable diagnostic tests that could be disseminated during the pandemic response.

Article author Dr. Catherine Bladen in Absolute Antibody’s ISO-certified antibody manufacturing facility in North East England.

· Flexibility to make or buy. When the pandemic hit, laboratories needed to limit employee interaction and follow social distancing guidelines; thus, decisions about what to do in-house versus outsource had to be made. Organizations needed to prioritize their core competencies. If their antibodies are of a recombinant nature, antibody expression can easily be outsourced in a reproducible and straightforward manner.

In summary, recombinant technology can be a solution for maximizing efficiency and strengthening the antibody supply chain, the importance of which became clearer than ever during the COVID-19 pandemic. Absolute Antibody’s expertise in recombinant antibody production enabled us to respond rapidly during the pandemic, creating recombinant COVID-19 antibodies in engineered formats for clients around the world and supporting those who wanted to transfer critical antibodies to recombinant production. Learn more at absoluteantibody.com.