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Aspen Alert

Issue # 3323 | November 5th, 2020      

   News Alert

Biogen Alzheimer's Drug Closer to Approval with U.S. FDA Staff Backing

Biogen has shown “exceptionally persuasive” evidence that its experimental Alzheimer’s disease drug is effective, U.S. FDA staff said this week, elevating its chances of a swift approval and sending company shares soaring. The agency’s documents were released ahead of a meeting on Friday of outside experts who will review, and decide whether to recommend approval of, aducanumab, an antibody designed to remove amyloid plaques from the brain. An FDA approval could come by March, which would make the drug, aducanumab, the first new treatment for the disease in decades and the first that appears to be able to slow progression of the fatal, mind-wasting condition that affects millions of people.
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Critics Say New NIH Policy on Scientific Data Sharing Falls Short

After a five-year effort, the National Institute of Health late last week released its final policy for managing and sharing publicly funded scientific data. But some critics say the approach falls short, because the language may still make it possible for researchers to withhold their data. The new policy, which replaces one issued in 2003, reflects an ongoing push for transparency by academics and scientists who maintain that, without access to scientific data, research cannot be easily replicated. For this reason, they have argued a lack of information inhibits greater scientific understanding that can adversely affect research decisions and, eventually, treatments and health care costs.
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Will a Small, Long-Shot U.S. Company End Up Producing the Best Coronavirus Vaccine? 

Eighteen months ago, a small vaccine maker called Novavax faced an existential threat: delisting by the NASDAQ stock index. On the heels of a second failed vaccine trial in less than 3 years, the firm’s shares had plunged to less than $1 for 30 straight days, triggering a warning by NASDAQ. Frantic to conserve cash, the company sold its two Maryland manufacturing facilities, slicing its payroll by more than 100 employees. By January, it employed only 166 people. What a difference a year—and a pandemic—make. Today, Novavax is slated to receive up to $2 billion from the U.S. government and a nonprofit organization to develop and manufacture a coronavirus vaccine.
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   Quote Alert

   On This Day Alert

George Foreman Becomes Oldest Heavyweight Champ

On this day in 1994,  George Foreman, age 45, becomes boxing’s oldest heavyweight champion when he defeats 26-year-old Michael Moorer in the 10th round of their WBA fight in Las Vegas. More than 12,000 spectators at the MGM Grand Hotel watched Foreman dethrone Moorer, who went into the fight with a 35-0 record. Foreman dedicated his upset win to “all my buddies in the nursing home and all the guys in jail.”
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  TED Alert

A Virus Detection Network to Stop the Next Pandemic

How can we stop the next pandemic before it starts? Disease researchers Pardis Sabeti and Christian Happi introduce Sentinel, an early warning system that detects and tracks viral threats in real time -- and could help stop them before they spread. Learn more about the cutting-edge technology that powers the system and how the Sentinel team is helping scientists and health workers during the coronavirus pandemic.
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  Poll Alert

Are you enthusiastic about putting up decorations at Christmas time?

► Yes
► No
 

Previous Poll Results:

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  Bioprocess Alert

Important Tools for Efficient Vaccine Development 

Many companies are working to advance the development of a vaccine in the context of the current COVID-19 crisis. New bioprocess technologies, such as single-use equipment and process automation, open up possibilities for quality control and validation. This is especially important in GMP-regulated environments, such as in the development and manufacturing of new influence vaccines. When facing a pandemic outbreak, the need to smoothly develop new processes and quickly scale up to clinical production volumes is key to efficiently develop new vaccinations. BioPharm International recently spoke with Dr. Jörge Schwinde, Key Segment Manager for Vaccines and Monoclonal Antibodies at the Bioprocess Center of Eppendorf, about the typical developmental process of new vaccines and how he COVID-19 pandemic influences the global vaccine developmental landscape.
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Survey Alert

Once in-person industry conferences resume, do you see an ongoing need for virtual conferences?  

► Yes
► No
 

Previous Survey Results:

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  Upstream Alert

Production Process Development of Pseudorabies Virus Vaccine by Using a Novel Scale-Down Model of a Fixed-Bed Bioreactor

In this study, a novel tube-fixed-bed bioreactor which consists of a TubeSpin bioreactor 50 tube and 0.44 g macrocarriers was developed as the scale-down model of a fixed-bed bioreactor. The adherent Vero cell–based pseudorabies virus (PRV) production process was tested in this novel model. The Vero cells grew well in the tube-fixed-bed bioreactor, and the cell density reached 5.8 × 106 cells/mL after 7 days of culture. The PRV production parameters (time of infection, multiplicity of infection, and harvest process) were optimized in the tube-fixed-bed bioreactor. The comparable growth curve, metabolism, and PRV production profile of the scaled-up bioreactors confirmed the feasibility and scalability of the tube-fixed-bed bioreactor as a scale-down model of the fixed-bed bioreactor for virus production process development.
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Event Alert

Blood and Plasma Manufacturing: How Robust Virus Removal Techniques Can Help Prepare for the Unexpected

Tuesday, November 10th, 2020

Dr. Michael Lasse, Product Manager Virus Clearance

Manufacturers of plasma-derived medicinal products (PDMPs) face increased challenges as the main raw material is of human origin and can therefore be contaminated with pathogens capable of causing direct infections in patients. Furthermore, routinely conducted testing on adventitious viruses is often limited to known contaminants and can easily fail on emerging and other unknown viruses. These circumstances not only present key challenges for scientists and engineers in downstream processing, but may also be of regulatory relevance. In this webinar, we will discuss the challenges and points that need to be considered when implementing virus safety concepts and present the benefits of virus filtration when it comes to establishing effective and reliable virus clearance steps within PDMP production. Furthermore, we will highlight the importance of robust, scalable virus clearance technologies such as Virosart® HC for the removal of emerging viruses like SARS-CoV-2 in biopharmaceutical manufacturing.
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 Downstream Alert

Biopharmaceutical Harvest and Clarification: Find the Right Fit

New industry trends often lead to new demands. As you work on an increasing range of products, which all still require a high-quality output, your process can become more complex. It can be a challenge to meet your yield and cost goals. These challenges bring the need for newer technologies. Review key process challenges and some options to overcome them. Newer technology, such as upstream chromatographic filters, may enable cleaner Proten A eluent and reduce the number of downstream unit operations required.
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  Podcast Alert

Reparations: How Could It Work?

The idea of paying Black Americans reparations for slavery has been around for a long time, but it’s starting to get more support than ever. So we ask: If the country does agree to pay up, how do you calculate the bill? And how could the U.S. come up with that kind of cash? To find out, we talk to historian and farmer Leah Penniman, economist Prof. William Darity Jr., public policy scholar Assistant Prof. Naomi Zewde, and Ebony Pickett. 
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  Regulatory Alert

FDA Awards Fast Track Designation to Multiple Non-COVID-19 Candidates

While the world has largely been focused on the development of vaccines and therapeutics for COVID-19, the U.S. FDA has remained busy lining up potential approvals of medications for other diseases and illnesses. Many of these drugs have been granted Fast Track designation over the past several weeks, which is intended to expedite the review of these treatments. BioSpace takes a look at some of the most recent medications to receive this designation.
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  Discovery Alert

AI Recognizes COVID-19 in the Sound of a Cough

Again and again, experts have pleaded that we need more and faster testing to control the coronavirus pandemic—and many have suggested that artificial intelligence (AI) can help. Numerous COVID-19 diagnostics in development use AI to quickly analyze X-ray or CT scans, but these techniques require a chest scan at a medical facility. Since the spring, research teams have been working toward anytime, anywhere apps that could detect coronavirus in the bark of a cough. In June, a team at the University of Oklahoma showed it was possible to distinguish a COVID-19 cough from coughs due to other infections, and now a paper out of MIT, using the largest cough dataset yet, identifies asymptomatic people with a remarkable 100 percent detection rate.
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  Project Alert

Pfizer to Invest $350 Million in Irish Manufacturing Sites

Pfizer is set to invest roughly $350 million in its three Irish manufacturing sites in Ringaskiddy, Dublin and Kildare. The investment will provide additional manufacturing and laboratory capacity, creating 300 roles over the next two to three years. The roles being created comprise a wide array of highly skilled positions such as engineers, scientists, technicians, and chemists. Part of this investment will allow the construction of a site at Ringaskiddy to manufacture pharmaceutical compounds for the company’s clinical trials across the globe. It will also mark the shift from manufacturing to support the earlier phases of medicine development.
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  Patent Alert

Chromatography Membranes, Devices Containing Them, and Methods of Use Thereof

A U.S. Patent for a "Chromatography Membranes, Devices Containing Them, and Methods of Use Thereof " was awarded to MilliporeSigma on October 13th, 2020. The present invention are fluid treatment devices for use in tangential flow filtration, comprising a housing unit and a composite material, wherein the composite material comprises: a support member comprising a plurality of pores extending through the support member; and a non-self-supporting macroporous cross-linked gel comprising macropores having an average size of 10 nm to 3000 nm, said macroporous gel being located in the pores of the support member.
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  Solution Alert

Do you have any information on a pipette that claims to enable volumes to be changed quicker and more easily? 

I think the product you are looking for is the EVOLVE manual pipette from Integra. According to the product literature, it utilizes adjustable dials that facilitate more than 10x faster changes in volume. Here is a link to more information;

EVOLVE

  Fact Alert

Until the early 20th century, the phrase "Pull yourself up by your bootstraps" meant something else entirely

It meant to do something impossibly absurd.
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   Career Alert

CHO Plus
Senior Scientist / Director Cell Engineering
South San Francisco, CA
This is a high-level molecular biologist position with responsibility for cutting edge cell line creation and contact with customers and partners. Learn More

Merck
Associate Director, Engineering Automation
West Point, PA
Manage a professional staff of ~ 14 engineers that provide process automation support to enable reliable and compliant supply of vaccines. Learn More

Aldevron Madison
Scientist III Fermentation, Process Development
Madison, WI
The ideal candidate leads complex projects in the areas of recombinant protein expression and fermentation, with an emphasis on methods development. Learn More

Bionova Scientific
Scientist II Cell Culture
Fremont, CA
This person will actively contribute to the development and technology transfer of projects at the Bionova Scientific West Warren site. Learn More

Kerry
R&D Director, Pharma
Beloit, WI
The role entails managing a technical team with a focus on cell nutrition (cell culture and microbiology) in addition to having functional leadership responsibilities. Learn More

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