CORRECTION: WuXi Biologics Acquires Bayer Manufacturing Site in Germany

                                                                                          Issue # 3114 | January 17th, 2020      




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WuXi Biologics Acquires Bayer Manufacturing Site in Germany

WuXi Biologics and Bayer have jointly announced an acquisition agreement that WuXi Biologics Germany GmbH will take over the operations of one of Bayer's final drug product manufacturing plants in Leverkusen, Germany, and purchase the associated equipment, in combination with a long-term lease contract for the building. Based on a manufacturing agreement to be negotiated, the plant would be operated by WuXi Biologics and serve as a back-up site for the final product manufacturing of Kovaltry™, an antihemophilic factor (recombinant). The transaction is expected to be concluded in the coming months subject to the satisfaction of customary closing conditions. Financial details were not disclosed.  Learn More

This story first appeared without the correct text, it has since been corrected to reflect the headline. Our apologies for any confusion.
 

   

Federal Court Upholds Ruling Invalidating Genentech's U.S. Patent for Reducing Protein A Leaching During Affinity Chromatography 

The Federal Circuit Court of the United States has affirmed the invalidation of Genentech's claims to methods for reducing Protein A leaching in affinity column chromatography in purifying monoclonal antibodies. This ruling comes after Genentech had appealed an earlier ruling by the Patent Trial and Appeal Board of the U.S. Patent and Trademark Office invalidating its Patent No. 7,807,799. All of which stems from an earlier request by Hospira for an inter partes review of the patent in question arguing anticipation and obviousness. Legal analysts are citing the ruling as yet another example of the higher courts deference to the U.S. Patent and Trademark Office. Learn More


   

Just-Evotec Building Late Stage Biologics Manufacturing Facility in Washington State

Just - Evotec Biologics has initiated construction of a 130,000 sq. ft. late-stage clinical and commercial manufacturing facility for biologics in Redmond, Washington. Construction on the greenfield site, located in Redmond Ridge Business Park, is expected to be completed by late 2020 and operational in the first quarter of 2021. The facility will contain manufacturing pods for implementing intensified fed-batch or continuous processing up to 1,000 L scale, with the capability of manufacturing metric tons of drug substance. Also included are supporting quality labs and process development labs. Learn More
 
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On this Day Alert

1953   Corvette Unveiled at GM Motorama


On this day in 1953, a prototype Chevrolet Corvette sports car makes its debut at General Motors' (GM) Motorama auto show at the Waldorf-Astoria Hotel in New York City. The Corvette, named for a fast type of naval warship, would eventually become an iconic American muscle car and remains in production today. Learn More

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What Your Breath Could Reveal About Your Health


There's no better way to stop a disease than to catch and treat it early, before symptoms occur. That's the whole point of medical screening techniques like radiography, MRIs and blood tests. But there's one medium with overlooked potential for medical analysis: your breath. Technologist Julian Burschka shares the latest in the science of breath analysis -- the screening of the volatile organic compounds in your exhaled breath -- and how it could be used as a powerful tool to detect, predict and ultimately prevent disease. Learn More

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If given the opportunity, would you want to go on the game show Jeopardy?

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Overview of Gamma Irradiation Processing


This video, produced by STERIS, walks the viewer through the equipment and processes required for successful gamma irradiation processing.

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Webinar:  Challenges Faced by the End Users During the Qualification of Single Use System

Presented by Ben Jeyaretnam, E&L Analytics Lead of Sanofi at Swiftwater and Dr Andreas Nixdorf, Team Manager at SGS Group

On Demand

The biopharma industry has been increasingly using single use systems (SUS) for bioprocessing and storage of intermediate and final bulk material in addition to primary packaging. Before a SUS could be used in the manufacturing process, it needs to be qualified for use by a pre-determined process. This presentation will discuss a variety of challenges, both internal and external to the industry that the end use faces during the qualification process. Complexity of SUS, varying quality of vendor data, component change management, changing regulatory expectations, analytical data generation, logistical challenges during E&L study execution, analytical challenges, and the potential impact of unexpected E&L study results will be presented.


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Small-Scale Bioreactor Supports High Density HEK293 Cell Perfusion Culture for the Production of Recombinant Erythropoietin

Process intensification in mammalian cell culture-based recombinant protein production has been achieved by high cell density perfusion exceeding 108 cells/mL in the recent years. As the majority of therapeutic proteins are produced in Chinese Hamster Ovary (CHO) cells, intensified perfusion processes have been mainly developed for this type of host cell line. However, the use of CHO cells can result in non-human posttranslational modifications of the protein of interest, which may be disadvantageous compared with human cell lines. In this study, we developed a high cell density perfusion process of Human Embryonic Kidney (HEK293) cells producing recombinant human Erythropoietin (rhEPO). The results from our study show that human cell lines, such as HEK293 can be used for intensified perfusion processes. Learn More

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Regulatory Alert



Stakeholders Seek More Clarity from FDA Draft Guidance on Clinical Decision Support Software

Industry groups, the Mayo Clinic, Regeneron and others are seeking more clarity from the US FDA's revised draft guidance on clinical decision support (CDS) software. The 27-page draft from September builds on a previous draft from 2017, with which industry also raised concerns. The latest draft clarifies the categories of CDS software subject to FDA oversight, as well as the low-risk categories of CDS software for which FDA does not intend to enforce regulatory requirements and CDS categories that do not meet the definition of a device. Weighing in on the draft, industry group AdvaMed praised its discussions of what types of software are, or are not, subject to FDA's oversight. Learn More
 
Discovery Alert

 

The Kill-Switch for CRISPR that Could Make Gene-Editing Safer

It started out as "sort of a stupid thing to do", recalls Joe Bondy-Denomy, a microbiologist at the University of California, San Francisco. As a graduate student in the early 2010s, he tried to infect bacteria with viruses that, on paper, shouldn't have stood a chance. He knew that these viruses, or phages, were susceptible to CRISPR-Cas, the bacterial defense system that scientists have harnessed as a powerful tool for gene editing. And in most cases, he was right: the CRISPR machinery chopped the incoming phages into bits. But in a few instances, against the odds, the intruders survived. Learn More

Project Alert



Just-Evotec Building Late Stage Biologics Manufacturing Facility in Washington State

Just - Evotec Biologics has initiated construction of a 130,000 sq. ft. late-stage clinical and commercial manufacturing facility for biologics in Redmond, Washington. Construction on the greenfield site, located in Redmond Ridge Business Park, is expected to be completed by late 2020 and operational in the first quarter of 2021. The facility will contain manufacturing pods for implementing intensified fed-batch or continuous processing up to 1,000 L scale, with the capability of manufacturing metric tons of drug substance. Also included are supporting quality labs and process development labs. Learn More