Author Archives: BPI Contributor

Your Reliable Contract Manufacturing Solution Partner in China

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This whitepaper focuses on Boehringer Ingelheim’s development and manufacturing facility in China. As one of the world’s leading organizations in the area of biopharmaceutical contract manufacturing, Boehringer Ingelheim is the first multi-national pharmaceutical company that brings over 30 years of experience in biopharmaceutical contract manufacturing to China, to better serve patients and the biopharmaceutical industry – both in China and in the world. As a pioneer in biopharmaceuticals with more than 35 years of experience the company has brought more…

September 30, 2015

How Molded Manifold Assemblies Prevent Leaks & Costly Consequences

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Molded tubing manifolds have roles to perform over and above being a transport vehicle for liquids. The assemblies must maintain leak-proof flow. They need to meet sterility requirements and help limit the need for cleaning and associated validations. They also must be cost effective, simple to use and efficient. When compared with hand-assembled tubing sets, the advantages of molded tubing manifold assemblies are clear. Tubing sets made from multiple components present a risk of leaks at every juncture. With barbed…

September 29, 2015

Simulation and Optimization Software for a Chromatographic Step

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This webcast features: Thomas Flouquet, Area Sales Manager/Application Specialist for low pressure chromatography BioSC® Predict is the first simulation and optimization software for the development of chromatography processes dedicated to the purification of biopharmaceuticals. Its innovation was recognized at the Achema 2015 Awards in the Pharmaceutical Engineering category. With a few clicks, the user can easily generate batch, parallel batch or continuous chromatography recipes and directly run them on BioSC® technology, with any adsorption media. BioSC® Predict is driven by…

September 17, 2015

EMD Millipore Introduces Enhancements to its EMPROVE® Program of Pharmaceutical Raw Materials to Facilitate Risk Assessment

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EMD Millipore, the Life Science business of Merck KGaA of Darmstadt, Germany, today introduced enhancements to its industry-leading EMPROVE® portfolio of pharmaceutical raw materials. The expanded documentation and regulatory information facilitates drug product manufacturers’ risk assessment workflows and supplier qualification. The enhancements also help drug product manufacturers meet their own internal quality guidelines as well as those recently published by the European Commission. This was the first regulatory body to formalize risk assessment requirements for pharmaceutical excipients, despite the practice being…

September 15, 2015

Cell Culture Media Supplementation: Effects of Peptones and CD Supplements on Performance and Protein Quality

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Biotherapeutic protein production is driven by cell line, cell culture media and supplementation, and bioprocess. While improvements in cell culture media and supplementation have enabled significant advancements in bioproduction titers, optimization to meet the specific needs of individual production cell lines continues to be a key factor to achieving desired production and protein quality. This is especially relevant to the ever increasing number of biosimilar therapeutics. Not only is it desirable to achieve a cost effective level of production, it…

September 2, 2015

Sartorius Stedim Biotech and GE Healthcare Sign Worldwide OEM Supply Agreement

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Sartorius Stedim Biotech, a leading international supplier for the biopharmaceutical industries and GE Healthcare’s Life Sciences business, a provider of start-to-finish enterprise solutions, technologies and services for biopharmaceutical manufacturing, today announced they have entered into a worldwide OEM supply agreement for Sartorius Stedim Biotech’s innovative membrane adsorber purification technology, Sartobindâ„¢. Under the terms of the agreement, SSB will manufacture membrane adsorber technologies for GE which will be marketed as part of GE’s ReadyToProcessâ„¢ product offerings. Membrane adsorber ion-exchange technology is…

September 1, 2015

BioFlex® TPE Biopharmaceutical Grade Tubing Now Available from Meissner

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Meissner’s BioFlex® TPE (thermoplastic elastomer) tubing offers next generation performance and the robust supply chain required for critical biopharmaceutical applications. The tubing is certified animal component free (ACF) and does not contain any silicone oils. The tubing’s remarkable clarity allows for enhanced visual process monitoring. BioFlex® TPE tubing is available in a variety of standard sizes and custom sizes can be accommodated upon request. The TPE tubing offers excellent sealing and welding performance. It is compatible with peristaltic pumping operations,…

August 21, 2015

Pfenex Inc. Awarded HHS Contract Valued At Up To $143.5 Million For The Advanced Development Of Next Generation Anthrax Vaccine

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Pfenex Inc. announced today it has signed a five year, cost plus fixed fee contract valued at up to $143.5 million with the Biomedical Advanced Research and Development Authority (BARDA) of the Department of Health and Human Services (HHS), for the advanced development of Px563L, a mutant recombinant protective antigen anthrax vaccine. “This contract for the development of Px563L offers the potential for a dramatic improvement in the rapid production of large amounts of a high value stable recombinant anthrax…

August 18, 2015

Redesigned Sartobind® Membrane Adsorber Capsules

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To more effectively recover large molecular weight proteins, such as blood factors and conjugated proteins or viruses and virus-like particles, Sartorius Stedim Biotech (SSB) has reconfigured its Sartobind® membrane chromatography capsules. A range of capsule sizes with a 4 mm bed height is now available from the 1 mL nano unit up to the new 2.5 L jumbo version. The capsules’ upstream flow channels have been optimized, and an internal core forms a miniaturized downstream channel, resembling that in existing…

August 12, 2015

Enzo Expands Immunoassay Offerings with Proinsulin and Insulin ELISA Kits

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As a leading manufacturer of ELISAs, Enzo Life Sciences continues to grow its immunoassay portfolio for metabolic research with the introduction of the Proinsulin and Insulin ELISA kits. Insulin is a peptide hormone made in the pancreas by beta cells and promotes the uptake of glucose from the blood into tissues, where it is stored in the form of glycogen and fat. By controlling glucose levels, insulin serves as the central regulator of fat and carbohydrate metabolism. Proinsulin is composed…

August 10, 2015