Article

Lyophilization: Protecting and preserving biologics

Lyophilization, also known as freeze-drying, is often a crucial step in the manufacturing process of biologics drug products. Biologics are large, complex molecules used to treat various diseases, including cancer, autoimmune disorders, and rare genetic disorders. These molecules can be challenging to chemically and physically stabilize, hence, alternative drug product manufacturing processes must be carefully evaluated and performed to maintain potency and efficacy. Lyophilization is one commonly used technique to stabilize biologics drug products and increase their shelf-life.

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Rapid discovery and characterization of monoclonal antibodies against the SARS-CoV-2 Delta spike protein

In the fall of 2021, the Delta variant of SARS-CoV-2 was the dominant strain in the US, being both more contagious than previous variants and more likely to lead to “long COVID” than subsequent Omicron variants. Here we describe the discovery and characterization of a large number of Delta spike-binding monoclonal antibodies (mAbs). By combining detailed DNA sequence analysis and binding assays, we identified 96 candidates for further analysis and development. Many of these hits exhibited neutralizing activity and also cross-reacted with one or more of the wild-type virus, Omicron 1.1.529, BA.2 and BA.5 variants.