MilliporeSigma today launched the Viresolve® Pro Shield H for removal of parvoviruses from therapeutic protein feed streams. The new Viresolve® Pro Shield H is designed for use as a prefilter with Viresolve® Pro Devices for more robust, cost-economic viral clearance. Viresolve® Pro Shield H removes protein aggregates and impurities that foul virus filters in high pH and high conductivity monoclonal antibody (MAb) feed streams. Combined with Viresolve® Pro Device parvovirus retentive filters, the Viresolve® Pro Shield H significantly increases processing…
Author Archives: BPI Contributor
Rentschler Doubles Manufacturing Capacity to Address Growing Demand for Biopharmaceuticals
Rentschler Biotechnologie GmbH, a leading contract development and manufacturing organization (CDMO) for biopharmaceuticals, today announced the opening of a new facility with an capacity of two times 3,000 liters at the company’s site in Laupheim. This innovative Twin system consists of two stainless steel bioreactors for the manufacturing of cell culture-derived proteins and is complemented by directly connected equipment for protein purification. The system increases Rentschler’s manufacturing capacity for the second time within a year; a new 2,000 liter single-use…
Continuous Chromatography of MAbs Using BioSC: Process Design and Regulatory Considerations
This webcast features: Vincent Monchois, Strategic Project Director, Biopharma, Novasep Challenges in bio-manufacturing up to commercial stage include improving lead times, securing the process, improving productivity, and reducing COGs. The implementation of a continuous manufacturing process is a viable solution to address these challenges. The chromatography step represents one of the key stages of a manufacturing process for (bio)pharmaceutical compounds. Continuous chromatography was originally developed by the Petroleum industry in the 1960s and has been successfully implemented in the Food-processing…
Fast monoclonal antibody titer determination with the TSKgel® Protein A-5PW column
The antibody therapeutics market is enjoying high growth rates, the major areas of therapeutic application being cancer and immune/inflammation-related disorders. Six of the top ten best-selling global drug brands are monoclonal antibody-based. This market is predicated to show continued growth for many years to come, with more monoclonal antibodies (mAbs) designed and produced for treatments of specific diseases. Early in mAb development there are many harvested cell supernatant samples which contain mAbs that are secreted by cell cultures. These samples…
Merck KGaA, Darmstadt, Germany, Joins DiViNe Consortium to Address Low Yields, High Costs of Vaccine Purification Processes
Merck KGaA, Darmstadt, Germany, a leading science and technology company, has joined theDiViNe project, a European consortium of six companies to address the biggest challenges facing the development, manufacture and delivery of vaccines. The objective of the DiViNe project is to create an integrated, cost-effective purification program specifically tailored for vaccines that achieves higher yields while preserving product integrity. Merck KGaA, Darmstadt, Germany’s specific focus will be on simplifying the process of vaccine purification that typically relies on affinity chromatography,…
Qosina Introduces New Barbed Check Valves
Qosina is pleased to announce the addition of eight new barbed check valves to complement their extensive line of stock components. Available in three different configurations, these barbed valves have a low, 0.087 psi cracking pressure.  The barb to barb straight and reducing configurations (#80500 – #80503) accommodate 1/8 inch (0.125 inch, 3.2 mm) and 3/32 inch (0.093 inch, 2.4 mm) ID tubes and are made of MABS and silicone. The female luer lock to barb and the barb to…
Lonza to Offer Novel Anc-AAV Gene Therapy Technology Through Exclusive Licensing Agreement with Massachusetts Eye and Ear®
Lonza Houston, Inc., a global leader in viral gene and cell therapy manufacturing, and Massachusetts Eye and Ear®, the world’s largest vision and hearing research center, have entered into a strategic agreement that provides customers the ability to in-license Anc80 and other Anc-AAVs for the clinical development and commercialization of novel gene therapies. The agreement is designed to accelerate gene therapy drug development across the field in order to address diseases in need of treatments and thereby ultimately reach more…
Distek, Inc. Releases Opt-Diss 410 In-Situ UV Fiber Optic System for Dissolution Testing
Distek, Inc., a leading manufacturer of laboratory testing instruments for the pharmaceutical and biotechnology industry, as well as an experienced provider of validation and qualification services, announced today the release of the Opt-Diss 410 next generation in-situ UV fiber optic system for dissolution testing. No more sampling! The Distek Opt-Diss 410 UV fiber optic system for dissolution testing measures directly in the vessel, eliminating problematic filters, tubing and pumps used in conventional sampling. Patented ARCH probes designed specifically for dissolution…
Acceleration of Bioprocess Development Using DoE and Physiological Control
This webcast features: Professor Christoph Herwig, Department of Biochemical Engineering, Vienna University of Technology Bioprocess Development for biotechnological high value added products is still a time consuming task. The reason for this is the high complexity of interdependence between process variables, product quality attributes and process parameters. The demonstration of understanding these interdependencies is however key to achieve regulatory acceptance according to Quality by Design (QbD) principles. Hence, it is important to set up senseful experiments and to gather as…
MilliporeSigma Launches New Gene Editing Technology to Engineer Virus Resistant CHO Cell Lines
MilliporeSigma today launched a first-of-its-kind gene editing technology to modify CHO cell lines to be resistant to minute virus of mice (MVM), a common contamination threat that remains despite the shift to chemically-defined, animal component-free manufacturing processes. CHO cells are commonly used in the manufacture of biologics. MilliporeSigma’s new Centinelâ„¢ technology targets genes which play a role in MVM susceptibility. Viral contaminations like MVM can have major consequences for biopharmaceutical manufacturers, costing hundreds of millions of dollars, according to industry…