Wednesday, April 26, 2017 Daily Archives

MilliporeSigma Releases Poloxamer 188 EMPROVE® EXPERT Polymer for Cell Culture Media

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The Poloxamer 188 EMPROVE® EXPERT polymer is a surface-active nonionic polymer used in cell culture media as a shear protectant and has become a standard component to cell culture media for production processes. The new polymer increases robustness of mammalian cells to shear from sparging, resulting in increased viability of cells in the bioreactor. For biopharmaceutical manufacturers, MilliporeSigma’s Poloxamer 188 EMPROVE® EXPERT polymer helps to ensure lot-to-lot consistency and reliable performance. The product has been cell culture tested, optimized and…

April 26, 2017

Accelerating Biosimilar Development Programs using Contract Testing and Manufacturing Organizations

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A rapid increase in the number of companies working on the development and registration of biosimilars and the need to get these products to market with speed has lead biosimilar developers to turn to contract research organizations (CROs) when they lack either the internal capability or capacity for conducting certain work. Throughout the biosimilar development pathway, a product sponsor can choose to conduct the work itself or use service contractors. Contractors can be niche providers of a single aspect of…

April 26, 2017

Contract Test Services from Associates of Cape Cod, Inc.: Specializing in Testing for Endotoxin and Glucan Contamination

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Associates of Cape Cod,® Inc. Contract Test Service (CTS) laboratory specializes in testing for endotoxin and glucan contamination and has notable experience in endotoxin testing. CTS performs all methods of the BET assay: gel-clot, chromogenic, and turbidimetric. CTS is GMP compliant and ISO registered. We’re licensed by the DEA as a laboratory capable of handling all controlled drug substances except those included in Schedule I. Endotoxin testing can be performed in accordance with FDA, USP, EP and/or JP, depending on…

April 26, 2017

Platform Purification of Six Biosimilar Molecules Using Amsphere A3 – Protein A Resin

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Currently more than 70 biosimilar mAbs (monoclonal antibodies) are under development and multiple originator mAbs are going off-patent in the next 3-4 years. Protein A resin remains the most important workhorse for the purification of monoclonal antibodies. Protein A resin has a high impact on both development and manufacturing cost, in particular during early stage clinical phases. This application note summarizes the key performance parameters for our high capacity protein A resin, Amsphere A3, for 6 biosimilar molecules of which…

April 26, 2017

Special Report: Effect of Insulin on Cell Growth and Virus Production

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Recombinant insulin is a key component in serum-free growth media for mammalian cells. It is used for the manufacturing of monoclonal antibodies, virus vaccines, gene therapy products and many other biological drug products approved by regulatory bodies worldwide, including FDA and EMA. Canada’s National Research Council (NRC) helps companies develop and commercialize new health technologies. Recently it partnered with Novo Nordisk Pharmatech to determine the effect of Insulin on cell growth and virus production. The results are detailed in this…

April 26, 2017