Aspen Alert

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Issue # 3324 | November 6th, 2020

News Alert

Merck to Acquire VelosBio for $2.75 Billion in Cash

Merck, known as MSD outside the United States and Canada, and VelosBio have announced that the companies have entered into a definitive agreement pursuant to which Merck, through a subsidiary, will acquire all outstanding shares of VelosBio for $2.75 billion in cash, subject to certain customary adjustments. VelosBio is a privately held clinical-stage biopharmaceutical company committed to developing first-in-class cancer therapies. VelosBio’s lead investigational candidate is VLS-101, an antibody-drug conjugate (ADC) that is currently being evaluated in a Phase 1 and a Phase 2 clinical trial for the treatment of patients with hematologic malignancies and solid tumors.
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Bluebird Bio Announces One Year Delay in Filing BLA for LentiGlobin

Bluebird Bio has confirmed its general agreement with the US FDA that the clinical data package required to support the Biologics License Application (BLA) will be based on data from a portion of patients in the HGB-206 study Group C that have already been treated. But the company said that the FDA had also requested the use of drug product manufactured from sickle cell disease patient cells in addition to healthy donors, as well as commercial lentiviral vector, to demonstrate drug product comparability. “Given this feedback, alongside COVID-19 related shifts and contract manufacturing organization COVID-19 impacts, bluebird is adjusting its submission timing to late 2022.”
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Who Should Get a Covid-19 Vaccine First?

In 2009 the flu strain H1N1, known as the swine flu, emerged unexpectedly, resulting in dealys in vaccine availability. This resulted in the CDC having to prioritize dosing, in the case of H1N1 it was determined that, in an effort to minimize deaths, the best approach was to vaccinate those between 6 months and 24 years as young people were understood to be more susceptible. Now, with the emergence of COVID-19 and the lack of adequate vaccines with which to dose everyone the question is once again, who should get vaccinated first. The science says it should be children and adults between the ages of 20 and 50 as they are the high transmission groups in this case. Raising ethical questions that promise no easy answers.
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Quote Alert

On This Day Alert

UN Condems Apartheid in South Africa

On this day in 1962, following the 1960 massacre of unarmed demonstrators at Sharpeville near Johannesburg, South Africa, in which 69 blacks were killed and over 180 were injured, the international movement to end apartheid gained wide support. However, few Western powers or South Africa’s other main trading partners favored a full economic or military embargo against the country. Nonetheless, opposition to apartheid within the U.N. grew, and in 1973 a U.N. resolution labeled apartheid a “crime against humanity.” In 1974, South Africa was suspended from the General Assembly.
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TED Alert

What's Missing from the American Immigrant Narrative

Recounting her story of finding opportunity and stability in the US, Elizabeth Camarillo Gutierrez examines the flaws in narratives that simplify and idealize the immigrant experience -- and shares hard-earned wisdom on the best way to help those around us. "Our world is one that flourishes when different voices come together," she says.
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Poll Alert

Are you enthusiastic about putting up decorations at Christmas time?

► Yes
► No

Previous Poll Results:

Bioprocess Alert

Advantages of Single-Layer Film vs. Multi-Layer Film for Use in BioProcessing Bags

Focusing on materials that enable single-layer storage solutions, this paper looks at plastic storage bags for bioprocessing applications, their challenges, and technology developments to address these challenges. Specifically, it focuses on materials that enable a shift from multilayer to single-layer storage solutions.
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Survey Alert

Are you now able to have vendors salespeople on site for product demos, training and the like?

► Yes
► No

Previous Survey Results:

Upstream Alert

Arc Sensors in Oncologic and Biosimilar Applications

In this application note we discuss how INOXTORRES has standardized their preparation reactors for oncologic and biosimilar applications with Hamilton Arc pH, conductivity, and dissolved oxygen sensors. The Arc System uses stable and reliable Modbus signal to provide direct communication to the process control system directly from the sensor. In this project, Arc sensors are used in total of 14 preparation tanks, 2 sterile filtration skids and 2 CIP systems, all mobiles and with volumes from 5 to 100 liter, and connected to a standalone automation and control system.
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Event Alert

Real-Time Viable Biomass Measurement in Challenging Microbial Applications Using Capacitance Technology

Wednesday, November 11th, 2020

Dielectric spectroscopy (DS), also known as capacitance technology, has been widely used as a PAT tool to measure biomass in real time, in various applications involving mammalian, insect, bacterial and microbial cells. It has been viewed as a particularly useful technology to measure cells in challenging microbial and bacterial applications, where other methods struggle to measure cell density reliably.

This webinar will start with an introduction to the invention of the technology and how the technology works (principle of measurement). Following this, the application of this technology in microbial and bacterial processes will be described with real world customer data. Relationship between capacitance and offline measurements such as dry weight and optical density will be demonstrated. Case studies will be presented where capacitance technology has been used for process fingerprinting, harvest time optimization, productivity improvement, real time troubleshooting and automatic process control.
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Downstream Alert

Frost & Sullivan Perspective on Next Generation Harvest Techniques

Frost & Sullivan recently invited academic and industry leaders in biopharmaceutical manufacturing to participate in a new and unique thought leadership forum, our Virtual Think Tank series. This forum brought together leading minds in manufacturing to discuss challenges, strategies, techniques, and barriers to new technology implementation in monoclonal antibody harvesting.
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Podcast Alert

Supervolcanoes

We keep hearing that a Yellowstone supervolcano could blow at any moment — and possibly wipe us all out. So is Yellowstone overdue for the BIG ONE, and if it happens, how bad could it be? To find out, we talk to paleoecologist Dr. Gill Plunkett, Yellowstone Volcano Observatory Scientist-in-Charge Dr. Mike Poland and Washington resident Christian Jacobsen.
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Regulatory Alert

CBER Head Peter Marks Fields Questions on Cell and Gene Therapy Development

Expect new guidance from the US FDA on the manufacture of CAR-T cells, said Peter Marks, director of the agency’s Center for Biologics Evaluation and Research (CBER). Marks answered questions on a range of issues related to cell and gene therapy development during a webinar hosted by Genetic Engineering & Biotechnology News. Saying that CBER is working on new guidelines for CAR T-cell therapy manufacturing, Marks said, “The agency is trying to put out some more clear information on what we’re expecting for CAR T-cells. I’m not sure exactly when it’s going to appear, but stay tuned,” Marks said.
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Discovery Alert

Resensitizing 'Last-Resort' Antibiotics for Treatment of Infections

A research team led by Professor Hongzhe SUN, in collaboration with Dr Pak-Leung HO, at the University of Hong Kong have discovered that by repurposing an antirheumatic gold drug, auranofin (AUR), "last-resort" antibiotics can be resensitized for treatment of infections caused by multidrug-resistant superbugs including bloodstream infections, pneumonia and wound infections. The findings provide insights into development of inorganic pharmaceutics and new therapeutic approach for superbug infections. The ground-breaking findings on antimicrobial resistance (AMR) are now published in a leading multidisciplinary science journal, Nature Communications and a related patent has been filed in the US.
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Project Alert

Revance Therapeutics Expected to Select Marlborough as Site for New Aseptic Fill and R&D Facility

Revance plans to lease a 79,000 square-foot single-tenant building on Campus Drive in Marlborough, Massachusetts. The new site would be home to both aseptic filling and R&D operations. Estimates have the initial capital investment at upwards of $115 million. Revance Therapeutics will create and maintain 76 permanent, full-time jobs at the site. The company has been in talks with city leaders about opening a facility for the past few months. It is understood that the last remaining hurdle is a 15-year tax increment financing deal which is expected to be approved in the coming weeks.
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Patent Alert

Method of Thermally Disinfecting a Centrifuge

A U.S. Patent for a "Method of Thermally Disinfecting a Centrifuge" was awarded to GEA on October 13th, 2020. The present invention is a method for thermally disinfecting a centrifuge by reducing a quantity of germs in the centrifuge, the method comprising: reducing the quantity of gems in the centrifuge using vapor that is not pressurized or which is at atmospheric pressure, wherein the centrifuge has a rotatable drum and is configured to centrifugally processing a product, wherein the vapor is passed through a feed, distributor ducts, a centrifuging chamber, a separating disk stack, and an outlet of the centrifuge, wherein, while the vapor is passed through the centrifuge, the drum is rotated.
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Solution Alert

In a recent group meeting one of my colleagues mentioned a recent webinar that addressed an application that coupled the Agilent 2D-LC with a SegFlow automatic sampling solution. Do you have any information on this event?

I took a look at our event calendar and I think I found it. The title was “Online Monitoring and Control of Upstream Titer, Product Quality and Amino Acid Content Using 2D-LC with SegFlow Interface”. Although the live webinar took place several weeks ago, I was able to identify an On-Demand link which is provided below

Agilent 2D-LC with Segflow Interface

Fact Alert

Medieval English longbows could fire an arrow further than 300 yards - which is almost the distance of 3 football fields.

So much strength was required to operate them that ancient skeletons can be identified as longbow archers due to their enlarged left arms.
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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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