The Use of Temperature Dependent Intrinsic Fluorescence for the Analysis of the In-Process Stability of a Protein

13 Mar 2014

This poster presents a study using in-process samples of a Monoclonal Antibody from a conventional purification development. Each stage of the process is assessed using a DOE approach to map the design space and find the optimal processing conditions. In parallel, a stability assessment of the antibody at each stage is carried out using the Optim® 1000 to determine the overall manufacturability of the product.

Optim 2: High Throughput Protein Stability Instrument

Avacta Analytical

Optim is an innovative analytical instrument designed to probe multiple protein stability-indicating parameters at high speed using ultra-low sample volumes of proteins and other molecules. Compact and robust, using a light scattering and fluorescence technology in a configuration never seen before and controlled by an all-new easy-to-use intuitive software package, the Optim 2 has been designed to reduce the time and cost of therapeutic protein preformulation studies, protein stability testing and formulation development.Optim 2 will simultaneously measure a range of protein stability indicating parameters including unfolding transition temperature (Tm), aggregation onset temperature (Tagg) and rates of aggregation, giving you greater insight into identifying the candidate molecules or formulations with the most favourable properties much earlier in the development process. Earlier analysis eliminates the cost associated with the unnecessary development of candidates or formulations that do not have the potential to proceed and dramatically reduces the chance of late-stage failure.Optim 2 Features: Speed of analysis - Capability to analyse up to 48 temperature controlled samples simultaneously. 144 samples measured in a high resolution thermal ramp per day Low sample availiability - Best in class sample volumes, only 9 microlitres per sample Orthogonal stability indicating measurements - Simultaneous fluorescence and light scattering analysis for label free probing of both protein unfolding and aggregation. Analysis of the effects of temperature, time and chemical environment on your biomolecule Applications: Lead candidate selection and optimisation Preformulation studies Candidate formulation Stability studies

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The Use of Temperature Dependent Intrinsic Fluorescence for the Analysis of the In-Process Stability of a Protein