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New Webinar Announcement - Biosimilar Characterization: Leveraging Protein Analytical Technology Within GMP Guidelines to Design a Pathway to a Successful Product

SelectScience
2 Oct 2013
Laura Burnett
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The SelectScience Editors are pleased to announce a complimentary, live educational webinar entitled “Biosimilar Characterization: Leveraging Protein Analytical Technology Within GMP Guidelines to Design a Pathway to a Successful Product” featuring guest speakers Dr. Sian Estdale, Manager of Protein Chemistry Services, Covance and Dr. Scott Berger, Snr. Marketing Manager, Biopharmaceutical Solutions, Waters Corporation.

Learn about the advantages of using QTof MS data for the characterization of a biosimilar candidate, to meet the standards of regulatory bodies such as the U.S.FDA and EMA, through case study examples.

Biopharmaceutical characterization requires: Confirming primary sequence through to identifying post-translational modifications (PTMs) in glycosylation, establishing biophysical and functional comparability for the innovator and candidate biosimilar, and performing studies that establish expected variation within an innovator biotherapeutic.

Time-of-flight mass spectrometry (Tof MS, or QTof MS) analysis of biosimilars offers:
• Biophysical and functional comparability and variability knowledge.
• Early knowledge of the target drug, to support late phase studies.
• Streamlined workflows, making rich characterization assays routine.
• Reduced analytical burden when manufacturing safe and effective products.

Dr. Michelle Maxwell, Drug Discovery & Development Editor at SelectScience, will be hosting the webinar which will be followed by a live Q&A session. A certificate of attendance can be provided upon request.

Webinar Information:

Date: Thursday 17th September 2013

Time: 5:00pm CEST / 4:00pm BST / 11:00am EDT / 8:00am PDT

Click here to check the time of the webinar in your country

Duration: 45 minute discussion, followed by a 15 minute live Q&A

Click here to learn more and/or register for this educational webinar

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Mass SpectrometryMass spectrometry (MS) is a powerful analytical technique used to identify and quantify molecules based on the mass-to-charge ratio of gas-phase ions. It provides detailed information about the structure, composition, and properties of compounds and is widely used across fields such as environmental monitoring, materials science, drug discovery and development, food and beverage testing, and wider chemical research. Key MS techniques include tandem mass spectrometry (MS/MS), liquid chromatography–mass spectrometry (LS-MS) and inductively coupled plasma (ICP-MS). Choosing from these wide range of techniques and technologies can be a daunting task, so keep up to date with scientific applications, performance expectations, and customer reviews here all in one place. Visit our product directory to receive quotes direct from the manufacturer. ProteomicsProteomics is the systemic bioinformatics study of proteins and amino acids, including their structure, size, function and identification. Tools used in proteomics include chromatography, blotting and gels, protein arrays, mass spectrometry and ELISA and associated analysis software. Analyzers and proteomic systems should be sensitive, high resolution, fast and may be automated for high-throughput.Medicinal ChemistryMedicinal chemistry is a broad discipline encompassing the design, identification, synthesis and development of chemicals in drug discovery. It includes a number of techniques covering structural biology, synthetic chemistry and molecular biology. Technologies used in medicinal chemistry include ADME, lab-on-a-chip, high content screening and assay assembly.MALDI-TOF MSMALDI-TOF mass spectrometers (matrix-assisted laser desorption/ionization time-of-flight) are used for the mass analysis of large molecules, including proteins, DNA, polymers and other macromolecules due to its relatively soft ionization, reducing fragmentation whilst allowing fast data acquisition. Tandem mass analyzers such as TOF/TOF systems can be used to increase resolution and sensitivity of your analysis. Find the best MALDI-TOF products in our peer-reviewed product directory: compare products, check customer reviews and receive pricing direct from manufacturers.Protein PurificationProtein purification is a vital step in drug discovery, therapeutics, biotech and life science research. The purification process typically involves subcellular or membrane protein extraction with cell lysis kits, separation of proteins from cell debris by filtration or spin columns, and the isolation of proteins of interest from other proteins and impurities with affinity purification (including fusion protein tags and antibody binding proteins A, G and L), immunoprecipitation or chromatographic methods, such as ion exchange, size exclusion and immobilized metal affinity chromatography. All purification methods come in multiple formats for your laboratory needs, including agarose or magnetic beads, resins, columns and filter plates. Find the best protein purification equipment in our peer-reviewed product directory: compare products, check customer reviews and receive pricing direct from manufacturers.Protein CrystallographyProtein crystallization is the process of crystallizing purified proteins for 3D structure analysis by x-ray crystallography. The main methods of protein crystallization include sitting drop, hanging drop and microbatch. It is important to control parameters such as pH, temperature and concentration. Following crystallization, detectors and software are used for data collection and analysis.Biopharmaceutical AdvancesBiopharmaceutical advances follow the development of pharmaceuticals derived from biotechnology, also known as biotechnology medicines. Biopharmaceuticals may be produced from cell lines, plants, or microbial cells. Important considerations of biopharmaceutical use include application, cost, production process and purification.BiosimilarsBiosimilars are very similar versions of approved and authorized medicines. Clinically inactive components will have minor differences, but there are no significant differences between the biosimilar and the original product in terms of potency, purity and safety.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.FDAThe Food and Drug Association (FDA) is an agency within the U.S. Department of Health and Human Services. Among other things, it is responsible for ensuring the safety, effectiveness and quality of drugs, vaccines and other biological products, and medical devices. 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.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.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.Drug DevelopmentDrug development refers to the process of bringing a new drug to market.

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New Webinar Announcement - Biosimilar Characterization: Leveraging Protein Analytical Technology Within GMP Guidelines to Design a Pathway to a Successful Product