Grace Launches ProVance Disposable Protein A Chromatography Columns to Help Reduce Costs and Time to Market for Biologics

6 Apr 2014
Kerry Parker
CEO

Product news

W. R. Grace & Co. announced the launch of ProVance™ pre-packed Protein A columns at Bioprocessing Development Week in San Diego, CA USA and the Bioprocess International Conference in Prague, Czech Republic. ProVance™ columns are a high-performance disposable chromatography solution to help meet the growing demand for downstream purification. Increasingly, major biopharmaceutical companies such as Pfizer, Boehringer Ingleheim, and Shire among others are shifting to single-use manufacturing for greater portability, scalability, and “rapid deployment” of biologics. Single-use technology offers unparalleled flexibility while reducing risk of contamination at multi-product facilities typical of contract manufacturing organizations.

Until now, there has not been a cost-effective Protein A chromatography option for single-use manufacturing facilities. ProVance™ columns combine Grace proprietary incompressible silica with cost-effective Protein A and disposable column hardware. The high capacity columns can reduce operating costs by 40-60 percent and are ideally suited for single-batch or single-campaign use eliminating the need for significant cleaning validations and long-term storage.

ProVance™ columns are available in a range of sizes for early screening and up to full-scale GMP manufacturing. Columns for use in GMP manufacturing come complete with documentation for regulatory support, shipping studies, and leachables, and extractables. More information is available at: www.grace.com/provance.

ProVance™ Prepacked Protein A Columns

W.R. Grace

ProVance™ columns are a high-performance disposable chromatography solution to help meet the growing demand for downstream purification. Until now, there has not been a cost-effective Protein A chromatography option for single-use manufacturing facilities. ProVance™ columns combine Grace proprietary incompressible silica with cost-effective Protein A and disposable column hardware.Grace is the world's largest supplier of specialty silica gel and has been manufacturing chromatography resins for the pharmaceutical industry for over 30 years. By combining Grace's large scale silica manufacturing and established quality systems with Repligen's industry leading recombinant Protein A and OPUS® column hardware, ProVance™ columns are uniquely positioned to transform your purification processes.

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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. 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.ChromatographyChromatography is a powerful technique used to separate and analyze components of mixtures based on their chemical properties. It is widely used in fields like biochemistry, pharmaceuticals, and environmental analysis. By exploiting differences in the interaction of substances with a stationary phase and a mobile phase, chromatography enables precise purification and quantification of compounds. Whether you're working with complex biological samples or industrial chemicals, chromatography is essential for obtaining high-quality results. Browse our peer-reviewed product directory to find the best chromatography systems, compare products, read customer reviews, and get pricing directly from manufacturers.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.
Grace Launches ProVance Disposable Protein A Chromatography Columns to Help Reduce Costs and Time to Market for Biologics