Aspen Alert

March 26, 2019

Bayer, J&J Settle U.S. Xarelto Litigation for $775 Million

Documents filed with the court this week find that Bayer AG and Johnson & Johnson have agreed to settle more than 25,000 U.S. lawsuits over their blockbuster blood thinner Xarelto for a total of $775 million. The amount will be shared equally between the two companies that jointly developed the drug. Bayer and J&J do not admit liability under the agreement. The settlement will resolve all pending U.S. lawsuits over Xarelto, which plaintiffs claimed causes uncontrollable and irreversible bleeding leading to severe injuries and even death among thousands of plaintiffs. Learn More

Thermo Fisher Acquiring CDMO Brammer for $1.7B

Thermo Fisher Scientific has agreed to acquire contract development and manufacturing organization (CDMO), Brammer Bio, for around $1.7B in cash. Owned by Ampersand Capital Partners, Brammer Bio is engaged in the clinical and commercial supply of vectors for in vivo gene therapy and ex vivo gene-modified cell therapy. The company has 600 employees at its primary locations in Massachusetts and Florida. Brammer Bio operates an 80,000 sq. ft. early clinical campus in Alachua, Florida. The company also operates a 66,000 sq. ft. phase III and commercial cGMP viral vector manufacturing facility in Cambridge, Massachusetts. Learn More

Mapi Pharma to Build Manufacturing Facility in Jerusalem

Mapi Pharma, which has developed a delayed release version of Teva's drug Copaxone, has announced that it will construct a manufacturing facility in Jerusalem. The new site, to be built even though the product has yet to receive formal marketing approval, is expected to have a total cost of roughly $12M and take a year to build. Mapi Pharma will use the several million dollars it receives from commercial partner Mylan, a well-known competitor of Teva's, to help pay for construction of the manufacturing facility that will employ 30 people. Learn More

Regulatory Alert

Reorganization of FDA’s Office of the Commissioner to Begin Soon

Beginning March 31st, the U.S. FDA Office of the Commissioner will reorganize and make several changes to various offices within FDA, including the Office of New Drugs (OND). With an eye toward efficiency and better connecting the Office of the Commissioner with center directors and other office leadership. A major change is the creation of the Office of Therapeutic Biologics and Biosimilars (OTBB) within OND. According to an email from Center for Drug Evaluation and Research (CDER) Director Janet Woodcock to staff, the OTBB will house policy and scientific review staff and realign staff from the OND Immediate Office to OTBB. Learn More

Resource Alert

Improved Performance in Mammalian Cell Perfusion Cultures by Growth Inhibition

Mammalian cell perfusion cultures represent a promising alternative to the current fed-batch technology for the production of various biopharmaceuticals. Long-term operation at a fixed viable cell density (VCD) requires a viable culture and a constant removal of excessive cells. Product loss in the cell removing bleed stream deteriorates the process yield. In this study, the authors investigate the use of chemical and environmental growth inhibition on culture performance by either adding valeric acid (VA) to the production media or by reducing the culture temperature with respect to control conditions. Learn More

Solution Alert

I need to monitor biomass during microbial fermentation, but there is a catch. The nature of my bioprocess makes a non-invasive solution necessary. Any suggestions?

That is one heck of a catch, but you are in luck. For some years now there has been a family of sensors, available in hand held and mounted versions, made by the folks at Bug Lab that meet the requirements you mention. In your question you specify non-invasive, both the hand held and mounted versions of these sensors meet that requirement, so the link below will take you to more information about each.

Bug Lab

Bioprocess Alert

Cell Culture Best Practices

This video, which has 3,000+ views, explains cell culture best practices and their role in improving reproducibility and reliability when culturing cells.

Market Alert

Previous Survey Results Are you satisfied with the sensing range, performance, and reliability of single-use sensors? Please comment on your reason(s). %

Participant Comment
"Performance is better but working materials of construction for noninvasive units"

Event Alert

Webinar – How iTHERM TrustSens Technology Meets the High Requirements for Calibration

Wednesday, March 27th, 2019

The new hygienic thermometer, iTHERM TrustSens, is designed for users in the biopharma industry requiring absolute compliance to cGMP standards. Our product eliminates the risk of undetected deviations during production by conducting a fully automated inline calibration before each bioprocess run without any effort. This results in maximum product safety and bioprocess availability.

In this webinar you will learn how the iTHERM TrustSens meets the high standards set forth for cGMP compliant calibration.

Learn More

Discovery Alert

New Drug Combination Shows Promise for Common Pediatric Brain Tumor

A new combination treatment aimed at resistant and recurrent low-grade gliomas slowed tumor growth and killed tumor cells in laboratory and mouse models. Researchers at the Johns Hopkins Kimmel Cancer Center and the Johns Hopkins University School of Medicine combined carboplatin, a standard chemotherapy drug that works well against these brain tumors, and everolimus, which blocks an enzyme called mTOR that was shown in earlier research to fuel the growth of these tumors. The combination increased DNA damage and cell death in laboratory models. Their findings were published in the February 14th, 2019, issue of Neuro-Oncology. Learn More

Patent Alert

Process for Manipulating the Level of Glycan Content of a Glycoprotein

A U.S. Patent Application for a "Process for Manipulating the Level of Glycan Content of a Glycoprotein" was published by Amgen on March 21st, 2019. The present invention is a recombinant protein produced by a method for manipulating the fucosylated glycan content on a recombinant protein comprising inoculating a bioreactor with mammalian host cells expressing the recombinant protein, culturing the mammalian host cells in a serum-free, chemically defined cell culture medium; wherein the cell culture medium includes from 10 to 100 ppb copper and from 50 to 1000 nM manganese. Learn More

Quote Alert

He was an American fiction writer whose works helped to illustrate the flamboyance and excess of the Jazz Age.

On This Day Alert

2001 Icelandic pop singer Bjork makes a splash at the Oscars

The Oscar nominee turned heads on the red carpet in an outfit resembling a swan. Over a nude body stocking and above a large white tutu-like skirt, the swan's neck was traped around Bjork's shoulders. Learn More

Poll Alert

Will the U.S. be more or less important in 2050 than it is now?

Click here to participate

Previous Poll Results (%) How does the arrival of Spring change your mood?

Aspen Participant Comment
"Spring means additional daylight and warmer weather that brings people outside!"

TED Alert

A Vision of the Future from IBM’s Most Prolific Inventor

What does the future look like from the eyes of the most prolific female inventor in IBM's history? Think: 3D printers building last-minute umbrellas at the office and toilet paper that automatically reorders itself when the last roll sits empty. Lisa Seacrat DeLuca envisions a radically reinvented world that surprisingly doesn't appear too different from today. Learn More

Project Alert

Foundation Medicine Moving to Seaport Amid Plans for Major BioPharma Campus

Foundation Medicine is subleasing 64,000 sq. ft. from PTC at 121 Seaport in Massachusetts, and it is likely the launch of a bigger Seaport real estate play, according to brokerage documents. The Cambridge-based company was also looking at Cambridge Crossing, but it has since zeroed in on the Seaport, particularly WS Development's Seaport Square, sources say. With city approval on a 7.7 million sq. ft. building plan, WS has several available blocks in its Seaport portfolio, depending on Foundation's space requirements, which published reports say include 300,000 to 400,000 sq. ft. of labs. Learn More