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

Avacta Analytical
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.

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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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ADME-ToxicologyADME-toxicology (ADME-Tox) studies are used in pharmacology and pharmacokinetics to assess the activity/toxicity of drugs <i>in vivo</i> or <i>in vitro</i>. Find bioassays for absorption, distribution, metabolism, and excretion of drug molecules including cytotoxicity, transporter/permeability, metabolism and activity assays as well as hepatocytes and cell lines for ADME. Find the best ADME-toxicology products in our peer-reviewed product directory: compare products, check customer reviews and receive pricing direct from manufacturers.Process ChemistryProcess chemistry is an important stage of drug development for scaling-up drug production or chemical synthesis reactions. It is useful for optimizing economical and efficient drug production. Process chemistry uses reactors and pump systems as well as reagents, standards and buffers.Drug DeliveryDrug Delivery refers to dosage form, route of administration, formulations, technologies, and systems for transporting a pharmaceutical compound in the body as needed to safely achieve its desired therapeutic effect. Drug delivery is often approached via the biopharmaceutical or small molecule drug's formulation, but it may also involve medical devices or drug-device combination products. Considerations include instrumentation, software and services. Scale-upScale-Up is generally defined as the process of transferring the results of the discovery phases of the drug discovery process, obtained on a laboratory scale, to the pilot plant and finally to production scale. Scale-Up uses reactors and pump systems as well as reagents, standards and buffers. Often Scale-Up is provided as a service by Contract Manufacturing Organizations (CMOs). Bioprocessing / FermentationBioprocessing is the use of biological materials to perform commercial, scientific or medical research processes. Biological materials used include cells, enzymes and organisms. Usually bioprocessing requires a batch or continuous bioreactor such as a fermentor or cell culture system. The advantages of using a reactor include high productivity, easy configuration, adjustable values and automation.Monoclonal AntibodiesMonoclonal antibodies (mAbs) are lab-made molecules that can bind to specific antigens on cells, making them highly effective in treating cancers, autoimmune diseases, and infections. These targeted therapies are transforming the treatment landscape for many conditions. Browse our peer-reviewed product directory to find monoclonal antibodies for research and clinical applications; compare products, check reviews, and get pricing directly from manufacturers.Protein BiologyThe analysis of protein expression, identity and function is vital for many areas of life science research and drug discovery. Some of the most commonly used techniques in protein analysis include Western blotting, electrophoresis and mass spectrometry.BiopharmaceuticalsBiopharmaceuticals are proteins and other compounds (such as nucleic acids) produced by living organisms that have uses as therapeutics or for in vivo diagnostics. The most well known example of a biopharmaceutical product, and the first to be approved for therapeutic use, was recombinant human insulin.

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