This presentation details insights shared by Ross Walton, a senior application scientist for biologics at Unchained Labs. Walton began by introducing himself and his company, which specialises in products for biologics and gene therapy research. Fast-tracking formulation screens of biologics is particularly important in development, said Walton, drawing an analogy to track cycling, where careful planning is followed by rapid execution.
Walton discussed four key products from Unchained Labs that form the Biologics Formulations Dream Team: Stunner, Unagi, Uncle, and Honeybun. Stunner is used for protein quantification and size analysis, Unagi for buffer exchange, Uncle for thermal stability testing, and Honeybun for viscosity measurements. Walton explained how each product contributed to the formulation screening process, highlighting their unique features and capabilities.
In a case study, Walton described the formulation screening of four monoclonal antibodies, including adalimumab and trastuzumab. These antibodies were buffer exchanged into a common formulation with different excipients such as sodium chloride, sucrose, and arginine. Walton detailed the buffer exchange process using Unagi, which involved positive pressure ultra-filtration and diafiltration. He noted that Unagi's orbital mixing prevented membrane fouling, ensuring faster and more homogeneous buffer exchange.
Walton then discussed the quantification and analysis of the antibodies using Stunner, which provided insights into protein size, polydispersity, and aggregation propensity. He highlighted that adalimumab did not perform well in sucrose, showing significant aggregation. Uncle can also analyse the stability of the antibodies using fluorescence, static light scattering, and dynamic light scattering to assess protein unfolding and aggregation.
The presentation concluded with Walton summarising the optimal excipients for each antibody at different concentrations. He noted that sucrose was generally preferred, but the combination of sucrose and arginine also showed promise for some antibodies. Walton stressed the need for balancing aggregation propensity and viscosity in formulation screening, and he encouraged leveraging the right tools for efficient and effective formulation development.
