Solutions for Large Molecule Applications
Since 2001, Freeslate has delivered high throughput research systems to over 30 pharmaceutical companies worldwide enabling them to overcome the issues of the traditional drug development process. Freeslate’s Biologics Formulation and Purification Systems were developed in collaboration with Johnson & Johnson, Novo Nordisk, and Amgen, and are designed to accelerate the development of biotherapeutics. Both systems are end-to-end solutions designed to enable biotherapeutic development scientists to get more information from less material and reagents. An entire experimental process is supported from intuitive experimental design, to full automation of the experiments, to the integration of analytical tools and data for faster, better development decisions. By enabling scientists to run more experiments in parallel, a much larger experimental space can be explored leading to shortened experiment cycles and improved development outcomes.
With the increasing number of biologics in the discovery/development pipeline, there is a need for a high throughput solution to assess the biophysical characteristics of biotherapeutics and their formulations. Freeslate’s Biologics Formulation System completely automates profiling biologics for their developability, preformulation screens, performing formulation robustness studies, and optimizing formulations against degradation, aggregation, and particulation. By taking an array-based approach, hundreds of experiments can be performed simultaneously with less material, enabling the efficient exploration of a larger formulation design space and reducing the risk of late stage failure.
Up to 75% of the manufacturing cost of a biotherapeutic can be attributed to downstream processing. Since purification is a significant contributor to the entire downstream process expenditure, identifying an optimal process is paramount to achieving overall success in process development. Miniaturization, parallelization, and automation of bioseparation experiments is at the heart of accelerating the development and characterization of downstream processes. Freeslate’s Biologics Purification System was designed to support the entire protein purification development cycle. For early development, the Biologics Purification System is capable of preparing and screening mobile phase conditions using plates pre-filled with process chromatography media, gradient experiments using small columns, and gross process optimization. For late development, the system is capable of performing process optimization and process characterization screens (e.g., response surface design or experiments, define critical process parameters, and define critical quality attributes). To enable full automation, buffer pH and conductivity are measured on-line and after purification, the Biologics Purification System prepares samples for on-line ELISA and UV-Vis analyses and off-line cSDS and cIEF analyses.
Click here to learn more about our solutions for Large Molecule Drug Development and how they can help you deliver dramatic gains in your R&D.