Aspen Alert

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Issue # 3320 | November 2nd, 2020

News Alert

Inside Operation Warp Speed’s $18 Billion Sprint for a Vaccine

On a late August day in an industrial corner of Baltimore that had been mostly silenced by the pandemic, a red-brick manufacturing plant was buzzing with activity. Deep in the building, in a zone called Area 3, the stainless-steel shell of a bioreactor lay on its side, having just arrived from Massachusetts. Employees had begun the task of making the bioreactor operational. Within weeks it would be the center of a production line for coronavirus vaccines. When the owner of the plant, Emergent BioSolutions, ordered the bioreactor, one supplier said some critical parts wouldn’t arrive until November or December. And so Emergent enlisted the help of Operation Warp Speed, officials from which called the supplier to say the order couldn’t wait, throwing the weight of the government behind the request.
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Novartis Expands Kymriah® Manufacturing Footprint with First-Ever Approved Site for Commercial CAR-T Cell Therapy Manufacturing in Asia

Novartis has announced the receipt of marketing authorization from Japan’s Ministry of Health, Labor and Welfare for Foundation for Biomedical Research and Innovation at Kobe to manufacture and supply commercial Kymriah® (tisagenlecleucel) for patients in Japan. This approval makes it the first and only approved commercial manufacturing site for CAR-T cell therapy in Asia. Novartis has the largest geographical CAR-T cell therapy manufacturing network in the world, including seven CAR-T manufacturing facilities, across four continents. Commercial manufacturing for Kymriah now takes place at five sites globally including at the Morris Plains, New Jersey facility, where the US FDA recently approved a further increase in manufacturing capacity. Learn More

Bellicum Pharma Announces Restructuring, Eliminating 79% of Workforce

Bellicum Pharmaceuticals has announced that interim data from its BPX-601 dose-escalation clinical trial failed to meet meaningful efficacy. After an extensive review of its organization and programs, the company has implemented a restructuring plan, including a reduction in staff, to focus its efforts on its clinical GoCAR-T® product candidates. Under the restructuring program, the company will focus on the clinical development of BPX-601 and BPX-603, pause the BCMA GoCAR-NK program, and discontinue discovery research and new product development. Staff will be reduced by 79%, from 68 to 14 full-time employees by the end of 2020.
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Quote Alert

On This Day Alert

Truman Defeats Dewey

On this day in 1948, in the greatest upset in presidential election history, Democratic incumbent Harry S. Truman defeats his Republican challenger, Governor Thomas E. Dewey of New York, by just over two million popular votes. In the days preceding the vote, political analysts and polls were so behind Dewey that on election night, long before all the votes were counted, the Chicago Tribune published an early edition with the banner headline “DEWEY DEFEATS TRUMAN.” Learn More

TED Alert

Sleep Is Your Superpower

Sleep is your life-support system and Mother Nature's best effort yet at immortality, says sleep scientist Matt Walker. In this deep dive into the science of slumber, Walker shares the wonderfully good things that happen when you get sleep -- and the alarmingly bad things that happen when you don't, for both your brain and body. Learn more about sleep's impact on your learning, memory, immune system and even your genetic code -- as well as some helpful tips for getting some shut-eye. Learn More

Poll Alert

Would you support or oppose a federal minimum wage of $15 an hour?

► Support
► Oppose

Previous Poll Results:

Bioprocess Alert

Fed-Batch Cultivation and Operational Conditions for the Production of a Recombinant Anti-Amoebic Vaccine in Pichia Pastoris System

It was developed a fed-batch bioprocess to produce a recombinant vaccine against Entamoeba histolytica under operational conditions attainable to large scale bioprocesses. We have produced this recombinant protein in shake flask and stirred tank bioreactor. Initial results in shake flask cultures under different methanol concentration of 0.5, 1.5 and 3% (v/v) produced extracellular protein at quantities of 10, 22 and 33 μg/mL, respectively. Then a scale-up process was performed from shake flask to fermenter by keeping similar volumetric power supply (P/V). The operational conditions were set up in fermenter as those used at commercial scale and supply of pure oxygen was avoided to keep the scalability of the bioprocess. Learn More

Survey Alert

Is the spending of year-end money, the idea that you must spend the remainder of your budget before the close of the year or lose it, fact or fiction?

► Fact
► Fiction

Previous Survey Results:

Upstream Alert

Methods and Process Optimization for Large-Scale CAR T Expansion Using the G-Rex Cell Culture Platform

The G-Rex cell culture platform is based on a gas-permeable membrane technology that provides numerous advantages over other systems. Conventional bioreactor platform technologies developed for large scale mammalian cell expansion are typically constrained by the mechanics of delivering oxygen to an expanding cell population. These systems often utilize complex mechanisms to enhance oxygen delivery, such as stirring, rocking, or perfusion, which adds to expense and increases their overall risk of failure. On the other hand, G-Rex gas-permeable membrane-based bioreactors provide a more physiologic environment and avoid the risk and cost associated with more complex systems. The result is a more robust, interacting cell population established through unlimited oxygen and nutrients that are available on demand. Learn More

Event Alert

Webinar: Tools for Preparing for Digital Transformation

Friday, November 6th, 2020

Scott Hluhanich
Danaher Business System Leader
IDBS

This presentation will explore tools that biopharma development organizations can use to prepare for digital transformation. We will discuss tools that help companies visualize complex processes in a simple diagram, tools for identifying waste and inefficiency in the process, and tools for visualizing the steps of complex processes.

Learn More

Downstream Alert

Activation of the Unfolded Protein Response via Co-expression of the HAC1i Gene Enhances Expression of Recombinant Elastase in Pichia pastoris

The effects of activation of the unfolded protein response (UPR) via co-expression of the HAC1i gene on the production of the recombinant Pseudomonas aeruginosa elastase (rPAE) in Pichia pastoris GS115 were evaluated in this study. The results showed that expression of the HAC1i gene significantly increased the level of Kar2p (a hallmark of UPR activation) in P. pastoris GS115, demonstrating activation of the UPR. This gene did not affect the growth of yeast in the buffered glycerol-complex medium but stimulated its growth in the buffered methanolcomplex medium. Learn More

Podcast Alert

Poe Toaster

For at least sixty years a mysterious person (or persons) showed up at Edgar Allen Poe’s grave to toast the master on his birthday. No one ever found out who this legendary figure was. Learn More

Regulatory Alert

EMA Outlines Regulatory Transparency Measures Amid COVID Pandemic

Reflecting the extraordinary circumstances of the pandemic, the EMA has announced that the agency is speeding announcements regarding the progress of clinical trials of vaccines and therapeutics for COVID-19. The agency is also making public certain information about the progress of clinical trials that would not ordinarily be published. Perhaps the most notable departure from business as usual is publication of full deidentified clinical trial data for COVID therapeutics and vaccines after they receive marketing authorization, a move EMA had announced in September. Learn More

Discovery Alert

Study Measures Effectiveness of Different Face Mask Materials When Coughing

A team of researchers have tested everything from t-shirts and socks to jeans and vacuum bags to determine what type of mask material is most effective at trapping the ultrafine particles which may contain viruses such as SARS-CoV-2, the virus which causes COVID-19. Previous studies have only looked at a small selection of fabrics when the wearer is breathing normally, when particles are expelled at lower speed. Studying more fabrics and testing them at higher speeds provides a more robust evidence base for the effectiveness of fabric masks. The results, reported in the journal BMJ Open, show that most of the fabrics commonly used for non-clinical face masks are effective at filtering ultrafine particles. Learn More

Project Alert

Sartorius to Open New Customer Interaction Center in North America

Sartorius is expanding its presence in Massachusetts with a North American Customer Interaction Center. Sartorius will be opening first units of the new 40,000-square-foot Customer Interaction Center in Marlborough in early 2021. "With our new site in Marlborough, we will be optimizing factory acceptance testing and commissioning of new bioprocess equipment supplied to the North American market. This investment will translate into tangible benefits for our customers, employees, suppliers, and the local community," said the President of Sartorius North America, Mary Lavin. Learn More

Patent Alert

Fluid Transport Apparatus, Flexible Conduit, Method of Manufacturing Flexible Conduit, and Storage Method

A U.S. Patent for a "Fluid Transport Apparatus, Flexible Conduit, Method of Manufacturing Flexible Conduit, and Storage Method" was awarded to Sartorius on October 13th, 2020. The present invention is a fluid transport apparatus defining an aseptic pathway configured to direct fluids therethrough is provided. The fluid transport apparatus may include a conduit extending between a first terminus and a second terminus. The conduit may include platinum catalyzed silicone rubber having methyl and phenyl side groups. A related flexible conduit, method of manufacturing a flexible conduit, and storage method are also provided. Learn More

Solution Alert

A co-worker mentioned that Beckman Coulter has set-up a virtual environment to showcase some of their bioprocessing solutions. I have looked at the various virtual conferences but have not been able to find it. Do you have any information on where I can find this resource?

The virtual environment you are looking for is actually free standing and available in two parts; the first being a Cleanroom and the second being a QC Lab. Among the products featured are particle counters, TOC analyzers, and cell counting/viability analyzers to name just a few. Here is a link to more information and access to the environment;

Beckman Coulter

Fact Alert

Only three people (Norma Cretal, Buzz Corey and Jimmy Calunga) in the USA were qualified to hand-pack the massive parachutes for the Apollo space capsules

Their expertise was so vital, they were not allowed to ride in the same car together for fear of an accident. Learn More

Career Alert

Novo Nordisk
MSAT Associate I
West Lebanon, NH
This position has the responsibility of working with senior level Scientists to execute laboratory scale process development or validation studies. 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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