Pharmaceutical Technology - November 2018

Pharmaceutical Technology - eBook

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Pharmaceutical Technology LABORATORY BEST PRACTICES 2018 41 cluding near-infrared and Fourier-transform in- frared spectroscopy are commonly used to assure the identity and quality of raw materials. These techniques allow a high volume of samples to be tested in an economical and reliable way. Bulpin (MilliporeSigma): Advancements and cost ef- ficiencies in employing analytical methods/tech- nologies now permit the use of orthogonal meth- ods to assess factors that can be quantified and compared during the testing of raw materials. In addition, evolution of methods that allow for high- throughput assessment and automation of many tasks allow for raw material testing to be scalable at production levels. Foehr (Pacific BioLabs): Many raw materials used in manufacturing may be analyzed using routine methods and commonly available instrumenta- tion. However, in this age of personalized medi- cine, stem-cell therapeutics, and immune-oncol- ogy drugs, the manufacturing of raw materials may include growth factors or cytokines. These raw materials require more advanced analysis and instrumentation to ensure proper safety and qual- ity. Manufactures may also use advanced instru- mentation to track cell growth and the status of growth conditions using multiplexed analysis of dozens or hundreds of markers. New gene therapy technologies may require so- phisticated molecular biology techniques to char- acterize the product and raw materials. Nucleic acid-based therapeutics such as oligonucleotides, RNAi, and CRISPR-based therapies are advanc- ing through the approval process and required biomanufacturing support. Techniques to study viral vectors, such as adeno-associated virus, and the raw materials used in their production are becoming more important as new-gene therapy drugs enter the market and are highly scrutinized by regulators. PT "Testing raw materials is a routine requirement; therefore, fingerprint technology including near- infrared and Fourier-transform infrared spectroscopy are commonly used." —Browne, Almac Sciences MORE ARTICLES For more about raw materials, read the following articles at • Ensuring the Biological Integrity of Raw Materials integrity-raw-materials-1 • Collaborating for Efficiency and Safety in Raw Material Inspection and-safety-raw-material-inspection • Analysis of Raw Materials • Ensuring Quality in Pharmaceutical Raw Materials pharmaceutical-raw-materials • Managing Risk in Raw Material Sourcing • Streamlining Raw Materials Testing • Risk Reduction Top Driver for Biopharmaceutical Raw Material Development biopharmaceutical-raw-material-development • Supply Chain Security Tops Concerns for Biopharma Raw Materials tops-concerns-biopharma-raw-materials

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