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Aspen Alert

Issue # 3426 | April 12th, 2021      

   News Alert

Lilly Gene-Targeted Drug Shows Potential for Use Across Cancers 

A gene-targeted drug sold by Eli Lilly can shrink tumors in a wide range of cancer types, not just the lung and thyroid malignancies in which the DNA mutations it's aimed at are most prevalent, new study results show. Treatment with the drug, called Retevmo, led to tumor responses in nearly half of 32 participants studied in the trial, who collectively had 12 different types of cancer. The finding, while from a small group of patients, could begin to build a case for using Retevmo to treat cancers based solely on their genes rather than location within the body. Only three drugs, including one developed by the biotech company Lilly bought to acquire Retevmo, have received such so-called tissue agnostic approvals from the Food and Drug Administration.
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Sanofi Acquires Tidal Therapeutics for $120 Million Upfront

Sanofi has acquired Tidal Therapeutics, a privately owned, pre-clinical stage biotech company with a novel mRNA-based approach for in vivo reprogramming of immune cells. The new technology platform will expand Sanofi’s research capabilities in both immuno-oncology and inflammatory diseases, while likely having broad applicability to other disease areas as well. Sanofi acquired Tidal Therapeutics for an upfront payment of $160 million and up to $310 million upon achievement of certain milestones. Tidal Therapeutics utilizes a novel mRNA-based approach to in vivo reprogramming of immune cells.
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White House Pushing for $6.5 Billion to Fund New Agency Focused on Curing Cancer

The Biden administration has begun to flesh out a proposal for a new agency—modeled on the military’s Defense Advanced Research Projects Agency (DARPA)—that would seek to speed the development of medical treatments by funding risky, innovative projects. The agency, dubbed ARPA-Health (ARPA-H), would be housed at the National Institutes of Health and have a 2022 budget of $6.5 billion, according to a White House spending request. Few other details about ARPA-H have been released, except that it would initially focus on cancer and diseases “such as diabetes and Alzheimer’s.”
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   Quote Alert

   On This Day Alert

1954 – Bill Haley and His Comets Record “Rock Around the Clock” 

On this day in 1954, Bill Haley and His Comets recorded “(We’re Gonna) Rock Around the Clock. Haley and the band had time for only two takes, and in the first, they played so loud that Haley’s vocals were almost inaudible on tape. In an era before multi-track recording, the only solution was to do a second take with minimal accompaniment and hope for the best. Later, a Decca engineer painstakingly spliced together segments from both takes—a near-miracle given the technology of 1954. The song is perhaps best known as the intro to the television classic “Happy Days”.
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  TED Alert

The Clock in Our Genes and in Every Cell of Your Body 

Joseph S. Takahashi, Ph.D. is the Loyd B. Sands Distinguished Chair in Neuroscience, an Investigator of the Howard Hughes Medical Institute, and Chair of the Department of Neuroscience at the University of Texas Southwestern Medical Center in Dallas. His research interests are the molecular mechanism of circadian clocks, neuroscience, and the genetic basis of behavior. Dr. Takahashi pioneered the use of genetics in the mouse as a tool for discovery of genes underlying neurobiology and behavior.
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  Poll Alert

After the COVID-19 pandemic is over, do you anticipate you will ever wear a protective face mask in public?

► Yes
► No

Previous Poll Results:

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  Bioprocess Alert

Has Protein Folding Been Solved?

Recently Deepmind made big headlines with its AlphaFold success. Did it really "solve" protein folding? What did actually happen? In this video I explain what the protein folding problem is, why it's important, and what the current situation is.
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Survey Alert

What is your view of the general state of single-use solutions as a whole in our industry today?

► Nearly commoditized
► Price has plateaued
► Novel technology
► Price continues to rise
► Commoditized
► Price beginning to decline

Previous Survey Results:

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  Upstream Alert

Characterization of Metabolic Responses, Genetic Variations, and Microsatellite Instability in Ammonia-Stressed CHO Cells Grown in Fed-Batch Cultures 

As bioprocess intensification has increased over the last 30 years, yields from mammalian cell processes have increased from 10’s of milligrams to over 10’s of grams per liter. Most of these gains in productivity can be attributed to increasing cell densities within bioreactors. As such, strategies have been developed to minimize accumulation of metabolic wastes, such as lactate and ammonia. Unfortunately, neither cell growth nor biopharmaceutical production can occur without some waste metabolite accumulation. Inevitably, metabolic waste accumulation leads to decline and termination of the culture. While it is understood that the accumulation of these unwanted compounds imparts a suboptimal culture environment, little is known about the genotoxic properties of these compounds that may lead to global genome instability. In this study, we examined the effects of high and moderate extracellular ammonia on the physiology and genomic integrity of Chinese hamster ovary (CHO) cells.
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Event Alert

Cell Line Development Tools For Rapid Prototyping of Intensified Bioprocesses ​ 

Thursday, April 15, 2021

As drug portfolios become increasingly diverse with more complex molecules that have higher development costs, biopharmaceutical manufacturers are turning to process intensification to increase efficiency, improve productivity, shorten timelines, and reduce production costs. Intensification in cell line development and early process development is the ideal starting point to achieve these goals. In this webinar, Sartorius experts review rapid prototyping tools to enable and assess intensified processes in cell line development. See how these tools help biopharma companies select clones suitable for intensification, leverage high cell density cell banking to shorten seed trains, and conduct early testing of intensified process to reduce risk, ultimately improving productivity and reducing COGS. 
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 Downstream Alert

Are Deep Eutectic Solvents Useful in Chromatography? A Short Review 

A literature update has been done concerning Deep Eutectic Solvents (DES) use in chromatography applications. The literature survey was based on the period from 2010 till 2020 and manuscripts reported in the data bases Web of Science and Scopus. The use of DES as mobile phase and mobile phase additives, stationary phases and solid phase modifiers and the use of DES as reaction solvents for chromatography use, were evaluated. Emphasis was placed on the differentiation of DES and Ionic Liquids (ILs) and the advanced green characteristics of the new solvents as compared with traditional organic solvents and ILs with a look into the drawbacks and future perspectives in the field of separation methods.
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  Podcast Alert

How Science Created Morons

This episode looks at how one of the worst ideas in science got a big push from a bad study… and intellectuals of the day lapped it up. We speak to science writer Carl Zimmer and Prof. J. David Smith, whose research helped get to the bottom of this messed-up story.
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  Regulatory Alert

"Very Rare" Thrombotic Events with AZ Vaccine, Concludes EMA's PRAC 

AstraZeneca’s COVID-19 vaccine may have a “very rare” but serious side effect of unusual blood clotting with a low blood platelet account, concluded the safety committee of the European Medicines Agency (EMA). The benefits of receiving the vaccine still outweigh risks, said the committee, hewing to the line EMA has held to throughout the investigation into reports of clotting events with the AstraZeneca vaccine. The conclusion reached by EMA’s Pharmacovigilance Risk Assessment Committee (PRAC) came from its April meeting where “the committee took into consideration all currently available evidence, including the advice from an ad hoc expert group.”
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  Discovery Alert

Aluminum is Intricately Associated with the Neuropathology of Familial Alzheimer's Disease 

A new study published in the Journal of Alzheimer's Disease Reports continues to support a growing body of evidence that aluminum contributes to the pathogenesis of Alzheimer's disease (AD). Researchers found aluminum co-located with phosphorylated tau protein, which is an early initiator of AD. This study builds upon two earlier published studies (including Mold et al., 2020, Journal of Alzheimer's Disease) from the same group. The new data demonstrate that aluminum is co-located with phosphorylated tau protein, present as tangles within neurons in the brains of early-onset or familial Alzheimer's disease. 
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  Project Alert

Andelyn Biosciences Receives Significant Investment and Enters Into Strategic Partnership with Pall Corporation and Cytiva

Andelyn Biosciences, a CDMO, has received a significant, minority investment from Pall Corporation. Additionally, as part of the investment, Pall Corporation and Cytiva, have entered into strategic partnership agreements with Andelyn. Andelyn is expanding its process development, analytical development and quality control capabilities. The company is also increasing its capacity to produce AAV and lentiviral vectors. In addition, the company is now offering clinical-grade plasmid manufacturing services, which helps advance drug delivery timelines for clients.
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  Patent Alert

Vessels and Spinner Flasks with Reduced Impeller Wobble for Culturing Cells

A U.S. Patent for "Vessels and Spinner Flasks with Reduced Impeller Wobble for Culturing Cells" was awarded to Corning on February 16th, 2021. The present invention is a vessel for culturing cells that includes a vessel body having a top portion, a bottom portion comprising a bottom interior surface, and a cylindrical sidewall. The vessel additionally has an impeller assembly inside the vessel body having a top portion rotatably coupled to the top portion of the vessel body, the impeller assembly having a plurality of planar blades, a central axis, a flexible shaft extending down from the top portion of the impeller assembly, a magnet receptacle molded within the plurality of planar blades, a magnet within the magnet receptacle, and an impeller o-ring coupled to a bottom surface of the planar blades. 
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  Solution Alert

Custom 5L Tapered Surge Bag for Final Fill Assembly 

Saint-Gobain created a tapered bag design with optimized placement of the fill port – keeping it low enough to be below the liquid level but also not too close to the drain port. This placement succeeded in reducing foaming and turbidity during operations. The bag was also customized to allow an attached vent filter to be held upright to pre- vent it from wetting out. This was accomplished by creating a hole below the handle bar through which a hose barb connected to the vent filter could be secured in an upright position.
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  Fact Alert

“Happy Days” Coined the Now Famous Phrase “Jumping the Shark”! 

In the three-part Season Five opener, “Hollywood”, Fonzie jumps a shark whilst water skiing. This is the point where many fans think the show started to really deteriorate in quality, and since then when shows suddenly take a big dip in quality or suddenly change their format in a big way that makes no sense, it’s known as “Jumping the Shark”!
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   Career Alert

PTC Therapeutics
Associate Director, Upstream PD, Gene Therapy
Pennington, NJ
This individual leads the design and execution of scale-up studies from pilot through full clinical and commercial scale. S/he also functions as PTC’s Person in the Plant (PIP). In this capacity, s/he provides Subject Matter Expertise (SME) for internally executed processes, as well as external, Contract Development Manufacturing Organizations (CDMOs)-executed processes, to ensure their proper execution. Learn More

Abbvie
Associate Scientist I, Bioprocess Development

Worchester, MA
An Associate Scientist I position is available within Purification Development group in Bioprocess Development Department at AbbVie Bioresearch Center in Worcester. The group is responsible for developing and supporting downstream manufacturing process for early and late phase clinical biologics programs.  Learn More

Takeda
Engineer II / Senior Engineer
Cambridge, MA
The individual will be expected to monitor and provide support for manufacturing operations. Responsibilities will include attending manufacturing morning meetings, daily production data trend review, event response and troubleshooting, batch review, deviation initiation support, and manufacturing personnel training. Learn More

Bio-Rad Laboratories, Inc. 
Field Application Specialist, Process Chromatography
Home-Based (Europe)
The Field Application Specialist (Field Support Scientist), a member of the Process Chromatography Media sales team, is responsible for providing technical expertise to customers in the field. The technical expertise is critical important to support customers in the route from drug development to commercial product related to downstream process challenges. Learn More

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