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Raw Material Identity Verification in Biopharmaceutical Production Using the Agilent RapID Raman System

Agilent Technologies
4 Mar 2019

Biological compounds derived from living cells offer exciting possibilities for treatment of a growing number of medical conditions. Most biologically derived proteins cannot be terminally sterilized and must be produced under aseptic conditions. This Application Note describes the use of spatially offset Raman spectroscopy (SORS) and the Agilent RapID Raman system for verifying common starting materials in biological production without compromising sterility.

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RapID - Portable Raw Material ID Verification

Agilent Technologies

The RapID Raman system is the next generation in raw material testing for pharmaceutical GMP quality control. RapID is a portable Raman spectrometer that uses Agilent’s spatially offset Raman spectroscopy (SORS) technology to extend high-throughput spectroscopic analysis through clear packaging to nontransparent and colored containers. This unique capability makes RapID ideally suited to noninvasive raw material identity verification.

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Raman SpectroscopyRaman spectroscopy is used to discern the vibrational and rotational states of molecules and hence the chemical composition of a sample by measuring the inelastic scattering of monochromatic light. Explore a range of Raman spectrometers, including handheld/portable Raman spectrometers for QC/QA labs and in situ spectrometers for processes. Conduct Raman imaging for microanalysis of mixed samples using a Raman microscope. Raman spectrographs are also available. Find the best Raman spectroscopy products in our peer-reviewed product directory: compare products, check customer reviews and receive pricing direct from manufacturers.RegulatoryPharmaceutical regulations impact on all areas of drug development, manufacture and control and supply. Services are provided from the early stages of drug development and clinical trials through to dossier submission, approval and marketing. Regulatory also includes submission of analytical studies from the pharmaceutical product and safety. 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.PharmaceuticalsPharmaceuticals are medicinal drugs used in healthcare to diagnose, prevent, cure and treat illnesses. Pharmaceuticals that are excreted after use appear in wastewater and can have detrimental effects on the environment.Raman

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Raw Material Identity Verification in Biopharmaceutical Production Using the Agilent RapID Raman System