Presented by Ross Walton, Senior Application Scientist for Analytics at Unchained Labs

As subcutaneous delivery of high-concentration biologics becomes more popular, optimizing their formulations becomes more complicated. Some excipients play better with one antibody, not another, or only help under specific conditions. Testing formulations at high protein concentration makes lower sample consumption and efficient assays a must-have. High-throughput, low volume solutions, designed for biologics, will speed up those formulation studies. Here, we present a case study on how to prepare monoclonal antibodies at high and low concentrations with some common excipients and screen for effects on quality, stability, and viscosity. 

The case study will illustrate how to produce all this data seamlessly, allowing the researcher to rate and rank formulations for their influence on the analyte and to quickly narrow down the optimal excipients.

Key Topics:

• Explore solutions for low volume, multi-parameter biologics formulation screening
• Learn how high-throughput buffer exchange and concentration can speed up antibody research
• Identify excipients to optimize monoclonal antibody stability and viscosity
• Determine the impact of increased protein concentration on formulations

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• Analytical method development 

• MS-based characterisation for biologics 

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• Serum vs. Serum-Free Media
• Cell Culture Conditions & Parameters
• Quality vs. Quantity
• Single-Use vs. Reusable Systems

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• Scalability & Manufacturing Complexity
• Supply Chain Management & Logistics
• Regulatory Compliance & Quality Assurance

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• Various vaccine approaches including peptides, proteins & mRNA

• Immunotherapies & anti-cancer therapies

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