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Aspen Alert

Issue # 3578 | November 10th, 2021      

   News Alert

Biogen Probes Death Possibly Linked to Alzheimer’s Drug Aduhelm

Biogen has launched an investigation into the death of a 75-year-old patient potentially linked to Aduhelm, the drugmaker's controversial Alzheimer's drug. The FDA approved Aduhelm on June 7 of this year via its accelerated pathway, sparking debate in the healthcare community among critics who say there is not enough scientific evidence that the drug works, and that there is evidence it can have severe side effects on the brain. The drugmaker says the 75-year-old patient was "diagnosed during hospitalization with cerebral edema thought to be ARIA-E," and the cause of death remains under investigation. During the two trials used for Aduhelm's approval, ARIA-E was the most common adverse event.
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Moderna and NIH at Odds Over Patent Rights to Vaccine

Moderna’s ongoing feud with the NIH over Covid-19 vaccine patents has spilled into the open. In a new report from the New York Times published this week, Moderna is asserting that three NIH scientists were not involved in inventing the key component in the biotech’s vaccine, to the surprise of the institute. The claim comes from a July filing with the US Patent and Trademark Office, which the NYT posted in full along with its report. Within the filing, Moderna said it had “reached the good-faith determination” that three NIH scientists — John Mascola, Barney Graham and Kizzmekia Corbett — “did not co-invent” the sequence that prompts the body’s immune response to the coronavirus spike protein. The NIH, meanwhile, says the trio worked with Moderna at the outset of the pandemic to design the component in question.
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Selkirk Pharma Acquires Land for Campus Expansion

Selkirk Pharma has entered into a purchase and sale agreement to acquire more than 10 acres of land adjacent to its 145,000-square-foot facility currently under construction at 9111 W. Granite Ave in Spokane, Washington. The land acquisition will expand Selkirk Pharma’s campus to a total of 27 acres and add “critically-needed capacity” for manufacturing commercial and clinical trial drugs. The campus will include three separate buildings with “industry leading technology” designed for contract manufacturing of injectable pharmaceuticals, including vaccines and biological therapeutics, according to the company. Selkirk has invested $90+ million in the West Plains manufacturing campus.
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   Quote Alert

   On This Day Alert

1903 - Mary Anderson Patents Windshield Wiper 

The patent office awards U.S. Patent No. 743,801 on November 10th, 1903 to a Birmingham, Alabama woman named Mary Anderson for her “window cleaning device for electric cars and other vehicles to remove snow, ice or sleet from the window.” When she received her patent, Anderson tried to sell it to a Canadian manufacturing firm, but the company refused: The device had no practical value, it said, and so was not worth any money. Though mechanical windshield wipers were standard equipment in passenger cars by around 1913, Anderson never profited from the invention.
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  TED Alert

The Science of Friction – And It’s Surprising Impact On Our Lives

Tribology: it's a funny-sounding word you might not have heard before, but it could change how you see and interact with the physical world, says mechanical engineer Jennifer Vail. Offering lessons from tribology -- the study of friction and wear -- Vail describes the surprisingly varied ways it impacts everyday life and how it could help us make a better world.
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  Poll Alert

Do you typically refer to the company that operates the most popular U.S. search engine as...

► Alphabet
► Google

Previous Poll Results:

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  Bioprocess Alert

Bioprocess Monitoring and Control: Challenges in Cell and Gene Therapy

Bioprocess monitoring and control are an essential requirement for safe and effective manufacture of bioproducts. This review provides an overview of some of the latest developments in analytical techniques, process variability, monitoring and control approaches for biologics, with a specific emphasis on the growing sector of cell and gene therapy. The monitoring and control challenges arising from the broad range of cell and gene therapy products, the complexity of these products and the processes required to produce them are outlined. Perspectives and implementation challenges are then set in the context of the regulatory framework.
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Survey Alert

Do you feel confident in the performance and reliability of the current single-use sensor offerings? Please comment on your reason(s).

► Yes
► No

Previous Survey Results:

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  Upstream Alert

The Role of Raman Spectroscopy in Biopharmaceuticals from Development to Manufacturing

Since first introduced in 2011 for industrial bioprocessing applications, Raman has become a first-choice PAT for monitoring and controlling upstream bioprocesses because it facilitates advanced process control and enables consistent process quality. This paper will discuss new frontiers in extending these successes in upstream from scale-down to commercial manufacturing. New reports concerning the use of Raman spectroscopy in the basic science of single cells and downstream process monitoring illustrate industrial recognition of Raman’s value throughout a biopharmaceutical product’s lifecycle.
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Event Alert

Biotech Boot Camp

Wednesday, January 29 to Wednesday, February 16, 2022

Frederick Community College is excited to announce the first "Biotech Boot Camp". This free 4-week training program is designed to teach participants the basic skills needed for entry-level positions in the biotech industry. The training program is a great opportunity for displaced workers and those interested in a career in biotech. Biotech Boot Camp will be held in person at Frederick Community College from January 19 to February 16, 2022, offering a hands-on training experience with a curriculum developed to address industry needs. The program will run for 4 hours, 4 days a week. Candidates must be over 18 years old and reside in Frederick County, Maryland to be considered for the bootcamp.
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 Downstream Alert

Bioreactor-Based Adherent Cells Harvesting from Microcarriers with 3D Printed Inertial Microfluidics

Harvesting adherent cells from microcarriers has become one of the major challenges of the downstream bioprocessing at large scale the current method has high maintenance and operation cost, which are the results of frequent clogging, due to cell lysing effect and microcarrier cake formation on membrane-based technology. These problems hugely impede the adaptation of microcarriers technologies in large-scale cell culture and hampered the supply of cells to the clinical need. Here, we describe two 3D printing-based methods to fabricate inertial microfluidic devices for separating adherent cells from microcarriers which overcome the above-mentioned limitations. The spiral devices are employed to separate mesenchymal stem cells from the microcarriers with 99% microcarrier removal rate and 77% cell recovery rate in one round of separation.
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  Podcast Alert

Taking Risks and Setting Precedent in Bioanalytical Assays for Cell & Gene Therapy

There are no bad ideas in developing bioanalytical testing, says Jim McNally, CSO of BioAgilytix. Not all ideas will work, of course. But he has found that it is the outside-the-box ideas that often turn out to be the solution in challenging assay work. Dr. McNally speaks with The Chain about his background in bioanalytical testing and supporting clinical trials, the exciting future of cell and gene therapies, and the importance of setting precedent in bioanalysis of these new, life-saving therapies. It is an exciting time for gene therapy especially, and Dr. McNally shares how new immunogenicity data is getting us closer to bringing this therapy to more people.
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  Fill/Finish Alert

Evaluating the Combined Impact of Temperature and Application of Interfacial Dilatational Stresses on Surface-Mediated Protein Particle Formation in Monoclonal Antibody Formulations

Formation of submicron and subvisible protein particles (0.1-100 μm) present a major obstacle during processing and storage of therapeutic proteins. While protein aggregation resulting in particle formation is well-understood in bulk solution, the mechanisms of aggregation due to interfacial stresses is less understood. Particularly, in this study, we focus on understanding the combined effect of temperature and application of interfacial dilatational stresses, on interface-induced protein particle formation, using two industrially relevant monoclonal antibodies (mAbs). The surface activity of Molecule C (MC) and Molecule B (MB) were measured at room temperature (RT) and 4°C in the absence and presence of interfacial dilatation stress using a Langmuir trough.
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  Regulatory Alert

Real-World Evidence from EHR Supports Antimicrobial Resistance Fight

An automated system that extracts real-world data from the electronic health record is as efficient as manual data extraction in gather real-world data to support research into antibiotic resistance, according to a new report on research supported by the US FDA. The data extraction project, supported by FDA through the National Action Plan for Combating Antibiotic-Resistant Bacteria (CARB), began with investigators from the Johns Hopkins University School of Medicine building an automated system to extract patient-level data from electronic health records (EHRs) at five Johns Hopkins hospitals.
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  Discovery Alert

How to Turn Specific Genes On and Off

Type 1 diabetes, rheumatoid arthritis, and cancer are just some of the disorders associated with specific genes not "turning on" and "turning off" as they should. By using new CRISPR/Cas9 genome editing technology, in a recent paper in Nature Communications, McGill University researchers have described a new technique that scientists across the world can potentially use to explore novel ways of treating diseases associated with dysregulation in DNA methylation. All the cells in an individual's body bear the same genetic code. It is the reading and writing of this code -- the "turning on" and "turning off" of specific genes in specific cells -- that gives the cells their identities.
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  Project Alert

New ECU Life Sciences Building Officially Opening

East Carolina University’s new Life Sciences and Biotech Building is finally officially opening after the university had approved days added to the project as a result of weather, Covid and supply chain delays in materials. The $90-million 4-story building at the corner of East 10th Street and Evans Street has been under construction since 2019. It has over 141,000 square feet of space and will be the home for the ECU Department of Biology and ECU researchers. ECU says the original contract completion date was July 14, 2021. 79 days were added due to weather and 22 due to scope, carrying the project completion to Nov 22.
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  Patent Alert

Substantially Aseptic Assembly for Processing Fluids

A U.S. Patent for a "Substantially Aseptic Assembly for Processing Fluids" was awarded to Sartorius on August 31, 2021. The present invention is an assembly for processing fluids comprising: a vessel having an opening; a vessel closure sealingly engaged to the opening of the vessel, the vessel closure comprising a top wall and a sidewall, the sidewall connected to and extending perpendicular to the top wall, the top wall including one or more apertures extending therethrough; one or more inserts extending through the one or more apertures; and a respiratory assembly configured to allow respiration of the vessel to an environment outside of the vessel, the respiratory assembly comprising: a housing seperably engaged with the top wall of the vessel closure to secure the housing to the vessel closure...
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  Solution Alert

A New Normal: Reflections on the Pandemic from Five Life Sciences Leaders

Image courtesy of "Apprentice" 

We’re all familiar with the ways COVID-19 has impacted our lives over the past year, from the trivial to the life-altering. But how did the people and companies responsible for producing the vaccine – the very thing that would return our lives to normal – cope with the disruption to their own jobs? Last week, five leaders of the top Life Sciences companies shared how they pivoted to keep production of the COVID-19 vaccine and other key drugs going in a radically altered world.
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  Humor Alert

  Fact Alert

You Should Change Most Wiper Blades 1-2 Times a Year

It’s pretty simple to identify when your car’s wiper blades are past their prime because the signs are hard to ignore. The wipers make scraping noises. They leave streaks on the windshield. Or the rubber on the blades has obvious signs of fraying and cracking. However, even after noticing these wiper blade problems, many drivers avoid replacing them. Typical wiper blades should be replaced once or twice a year, based on the following factors:

  • Weather- Extremely sunny conditions can wear down rubber and cause it to crack. Freezing winter temperatures can also age wiper blades, so in cold regions it’s wise to replace blades in late fall and early spring.
  • Blade material- Rubber wiper blades are usually the cheapest, but they also wear out fastest. Blades made from stronger materials, such as silicone or halogen-hardened rubber, may last over a year.

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   Career Alert

Sartorius
Product Specialist, Chromatography Hardware - Remote
Field Application Specialist, Bioprocessing – Chromatography - Remote
Field Application Specialist, Bioprocessing – Chromatography - Remote
New Customer Sales Specialist - Marlborough, MA
Customer Development Specialist - Marlborough, MA
Customer Development Specialist - Fremont, CA
Customer Development Specialist - Remote
Order Process Management Specialist - Bohemia, NY
Order Process Management Specialist - Marlborough, MA
Order Process Management Specialist II - Bohemia, NY
Order Process Management Specialist III - Bohemia, NY

Saint-Gobain
Applications Engineer II
Beaverton, MI
In this position, the employee will work with customers in developing innovative Single-Use solutions for Bio/pharmaceutical & Medical applications using Saint-Gobain and other supplied components. Learn More

Sanofi
Principal Engineer, Upstream
Framingham, MA
The successful candidate will work with a group of scientists and engineers responsible for technology transfer mammalian cell culture processes to a diverse network of manufacturing facilities, Lifecycle Management and support of commercial processes. Learn More

GSK
Associate Scientist - Downstream Process Development
King of Prussia, PA
As an Associate Scientist in Downstream Process Development, you will be a member of a highly skilled team of scientists and engineers responsible for the evaluation and optimization of purification processes. You will be involved in all aspects of the development of purification processes. Learn More

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