Author Archives: BPI Contributor

LEWA Ships First Multi-Column Chromatography Unit for Use in GMP Environment

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LEWA became the first to market with a twin column low pressure chromatography system at the pilot scale designed for use in GMP environments with its recent shipment to the Fraunhofer Institute for Interfacial Engineering and Biotechnology (Stuttgart, DE). The GMP scale unit (EcoPrime® Twin LPLC) can be configured to allow drug manufacturers to use a twin column unit in multiple modes: full continuous purification, integrated (continuous) batch and batch – with built in capability to operate columns in series,…

July 6, 2016

MilliporeSigma to Develop Next-Generation Purification Processes with International Vaccine Institute

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MilliporeSigma has entered a research agreement with the International Vaccine Institute (IVI) of Seoul, South Korea to help develop more robust, scalable vaccine manufacturing processes. MilliporeSigma will provide funding and expertise in the areas of clarification and purification. The IVI is a nonprofit international organization committed to the discovery, development and delivery of safe, effective and affordable vaccines for global public health. The new collaboration between MilliporeSigma and IVI is aimed at improving the manufacturing process to deliver greater yield, allowing…

June 28, 2016

MilliporeSigma Expands Industry-Leading Emprove® Program to Include Filtration and Single-Use Products

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MilliporeSigma today has expanded its industry-leading Emprove® risk assessment program to include a selection of products for filtration and single-use processing. The program provides documentation and regulatory information on materials used in the manufacture of drug products. This information enhances transparency, facilitates manufacturers’ risk assessment workflows and supplier qualification. “As the regulatory landscape continues to evolve, rapid and easy access to risk assessment information is even more critical,” said Udit Batra, Member, Executive Board, Merck KGaA, Darmstadt, Germany and CEO, MilliporeSigma. “The…

June 28, 2016

Sartorius Acquires Cell Screening Specialist IntelliCyt

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Sartorius, a leading international pharmaceutical and laboratory equipment provider, today announced the acquisition of U.S. based IntelliCyt Corporation, an award-winning innovator and manufacturer of novel cell screening platforms used in drug discovery. Through the acquisition, Sartorius expands its current lab portfolio into bio analytics, thus substantially strengthening its offering for biopharma customers and academia. Sartorius purchased IntelliCyt for $90 million in cash, which includes approx. $5 million in future tax savings. The company focuses on pharma, biotech and academic customers,…

June 28, 2016

A comparative study of MiniTEMâ„¢ versus DLS Zetasizer Nano and NTA NanoSight NS300 performance when analyzing < 50 nm particles

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Characterization and analysis of subvisible particles of biological origin can be challenging or give insufficient information. In this study Adeno associated virus (AAV) particles contaminated by host cell proteasomes are analysed with direct versus indirect methods performed in a standard laboratory setting to reveal the difference in performance and quality of the information obtained. The focus is on the ability to detect the AAV particles of interest and distinguish them from the contaminating proteasomes. The compact, tabletop MiniTEM system enables…

June 23, 2016

Finesse and One Hill Solutions Release SmartLabâ„¢ Platform for Lab-Scale Bioprocess Optimization

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Finesse Solutions, Inc., a manufacturer of measurement and control solutions for life sciences process applications, in partnership with One Hill Solutions, an innovative software developer in Massachusetts, announced the launch of the SmartLab platform for lab-scale bioprocess optimization. SmartLab is the first end-to-end data management system to integrate leading third-party design-of-experiment (DoE) software, multivariable data analysis (MVDA), recipe management, data visualization and seamless analyzer connectivity. SmartLab is based on the RECONN software engine developed by One Hill Solutions. It also…

June 21, 2016

Modification of Glycans in Bioprocessing

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This webcast features: Ryan Boniface, R&D Scientist, Thermo Fisher Scientific Protein quality is a topic of increasing importance as quality elements can have a significant impact on clinical behavior of a molecule. This talk will explore approaches to modify glycan patterns contribute to predicting, achieving and maintaining preferred glycosylation profiles. Glycosylation is a key product quality attribute for many biotherapeutic proteins expressed in CHO cells. N-linked glycans may display macro- and micro-heterogeneity; the degree of this variation can depend on…

June 17, 2016

New Sartorius Stedim BioOutsource Microsite Goes Live

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Sartorius Stedim Biotech (SSB), a leading international supplier for the biopharmaceutical industry, announced that its subsidiary BioOutsource launched an updated website to spotlight Sartorius Stedim Cellca’s cell line and upstream process development services for the biopharmaceutical industry. The new microsite features insights into the technology and development services of Cellca most recently acquired by SSB. The availability of both subsidiaries’ unique range of integrated services will support biopharma companies to rapidly and cost-effectively develop their biologics and biosimilars. The new…

June 14, 2016

Sartorius Stedim Biotech Presents Virosart® Media

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Sartorius Stedim Biotech (SSB), a leading international supplier for the biopharmaceutical industry, has launched Virosart® Media for virus retention in cell culture media. With this new media filter, the company offers a fast and cost-effective solution for manufacturers to reduce the risk of virus contamination resulting from raw materials, such as chemically defined media, during fermentation. Virosart® Media is a single-use filter that provides the highest level of safety for customers’ upstream processes as it is qualified for > 4…

June 13, 2016