Author Archives: BPI Contributor

2D DIGE Western Blot for HCP Detection and Coverage Determination: Advantages of Fluorescence over Colorimetric Detection

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This webcast features: Jamina Fiedler, Head of 2D Analytics at BioGenes GmbH. Biopharmaceutical products need to be free of contaminating host cell proteins (HCPs) prior to approval and regulatory bodies ask for a clear and manifest proof that HCP assays are fit for purpose. The colorimetric 2D Western Blot method, although widely used for HCP detection and coverage determination, has several limitations. Using examples, webinar participants will learn how the use of fluorescent dyes can help overcome these limitations to…

January 29, 2015

Selexis Generated Research Cell Banks Now Fully Sequenced Using Next-Generation Sequencing

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Selexis SA, a serial innovation company with proven technologies for characterized mammalian Research Cell Banks (RCBs) used for drug discovery to commercial manufacturing, announced today all Selexis generated Research Cell Banks will include Next-Generation Sequencing (NGS) data packages. The NGS analysis of the cell’s genetic architecture de-risks biologic manufacturing by ensuring the integrity of the gene, validation of the left and right integration sites and providing a comprehensive genetic baseline that allows for a novel way to code and trace…

January 22, 2015

GEA Niro Soavi’s PandaPLUS 2000: Table Top Laboratory Homogenizer

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GEA Niro Soavi the leader in high pressure homogenization, offers a table top laboratory homogenizer, the PandaPLUS 2000, which is ideal for the treatment of nanoparticles, nanodispersions, nanoemulsions, and cell disruption. This compact laboratory homogenizer is the perfect solution for the micronization of liquid pharmaceuticals, cosmetics and chemical products. Laboratory scale and pilot scale can models can operate from 0 to 2000 bar, even with limited sample volumes, and achieves the same results as larger models. This is how the…

January 21, 2015

New Separator Lines for Processing Algae: algaeprime and algaepro

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GEA Westfalia Separator has successfully launched a new separator generation for the concentration of algae: algaeprime and algaepro. The prime series with its capacity range from 100 to 23,000 L/h is ideal for research and development, but also for start-up companies. It offers high flexibility for processing all kinds of algae with all possible recipes, features easy and simple operation, high capacities and separation efficiency along with maximum scale-up safety. The algaepro series on the other hand is the best…

January 20, 2015

NeoStem Receives Drug Manufacture License for Irvine Facility

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NeoStem, Inc. (NASDAQ:NBS) a leader in the development and manufacturing of cell therapy products and regenerative medicine, announced today that the State of California’s Department of Public Health, Food and Drug Branch has completed its review of NeoStem’s manufacturing and control processes at its Irvine, California cGMP facility for the production of eltrapuldencel-T (also known as NBS20) and has issued NeoStem a manufacturing license permitting NeoStem to manufacture drugs from this facility, including the manufacture of eltrapuldencel-T for clinical trial…

January 20, 2015

FUJIFILM Completes Acquisition of Kalon Biotherapeutics

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Acquisition Enhances Texas’ Growing Reputation as a Global Biotechnology Leader FUJIFILM Diosynth Biotechnologies U.S.A. Inc. (FDBU), a FUJIFILM Corporation subsidiary, today announced the completion of its acquisition of Kalon Biotherapeutics LLC, marking an important new chapter in the emergence of the Texas biosciences industry as a center for world-class development and manufacturing of life-saving biopharmaceuticals and biotechnology while providing FUJIFILM Diosynth Biotechnologies with expanded capacity for its growing vaccine capabilities.  The completion of the previously announced Purchase Interest Agreement of…

December 20, 2014

Flow Electroporation Capabilities and Case Studies: Rapid GPCR Screening and Functional Ion Channel Assays

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MaxCyte’s proprietary flow electroporation technology has been successfully applied in ex vivo cell therapy (1) and drug discovery pipelines where reproducibility, efficiency and the need for increased cell numbers are critical. This technical paper discusses the merits of transient transfection using flow electroporation versus other recombinant expression approaches and its application in hit identification and lead optimization programs. Data are presented demonstrating the key features of the MaxCyte® STXâ„¢ Scalable Transfection System, including broad applicability, scalability, and the production of…

December 15, 2014

Delivering Fit-for-Purpose Biomanufacturing CHO Cell Lines

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A prerequisite for the successful manufacture of a biopharmaceutical in mammalian cells is a cell line development strategy that selects a cell line with the most desirable properties from a heterogeneous transfectant population. Desirable attributes include the stable, high expression of product with the appropriate critical product quality attributes rapidly, reproducibly and with relative ease. Obtaining a host cell line that inherently exhibits such desirable biomanufacturing attributes can therefore have a significantly positive effect on the identification of recombinant cell…

December 15, 2014

Symphogen A/S Licenses the Selexis SUREtechnology Expression Platform and Cell Line

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Selexis SA, a serial innovation company with proven technologies for biologic drug discovery and mammalian cell line development announced today that Selexis and Symphogen A/S have entered into a commercial license agreement and signed the continuation of their R&D license agreement. Symphogen has licensed the rights to the Selexis SUREtechnology Platformâ„¢ and SURE CHO-M Cell Lineâ„¢ for the development of recombinant monoclonal antibody (MAb) mixtures for the treatment of various cancers and infectious diseases. Symphogen has developed unique technologies for…

December 9, 2014

Assessing Immunogenicity Using Ex Vivo T cell Assays

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This article discusses Antitope’s developed highly sensitive ex vivo T cell assay technology that can detect T cell responses against T cell epitopes in therapeutic proteins. These assays can be used to select non-immunogenic lead proteins as well as support the optimisation of leads by engineering out T cell epitopes

December 5, 2014