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Aspen Alert

Issue # 3714  |  May 19th, 2022      

   News Alert

Judge Weighing Motion to Dismiss Henrietta Lacks’ Family Lawsuit Against Biotech Firm

The fate of the lawsuit filed by the estate of Henrietta Lacks against a biotech company for non-consensual use of her cells hangs in the balance as a judge considers if and how Maryland’s statute of limitations would apply. By the end of this week’s roughly two-hour hearing in Baltimore, U.S. District Court Judge Deborah L. Boardman said it was difficult to take the “extraordinarily unique facts” of the case and apply them to the law. Lacks’ family is suing Thermo Fisher Scientific, a multibillion-dollar biotech company, over its use of her living cell samples that were collected without her knowledge or consent during a medical procedure in 1951.
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Cancer Experts Hail a Molecular ‘Black Box’ That Records How Cells Fly into Tumor Territory

Biologists Tyler Jacks and Jonathan Weissman’s mice may look like any other lab mice — plain, pale, and furry — but cancer geneticists see them as a “technical tour de force.” “It’s a pretty heavily engineered mouse,” said Weissman, a biologist at the Whitehead Institute. Engineered into that mouse is intricate molecular machinery that allowed Weissman and his team to trace the ancestries of single tumor cells, placing them on a tumor’s family tree with an unprecedented level of detail. With those findings, scientists say that Weissman, in a new paper published this month, has begun to uncover new insights into the fundamental biology of tumors and how they evolve.
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'Pharma Bro' Shkreli Freed from Prison for Halfway House

Convicted pharmaceutical executive Martin Shkreli was freed this week from prison after serving much of a seven-year prison sentence for lying to hedge fund investors and cheating investors in a drug company. His attorney, Ben Brafman, said Shkreli, 39, was released early from a prison in Allenwood, Pennsylvania. The move was confirmed by the Federal Bureau of Prisons. Shkreli was moved to a halfway house overseen by the Federal Bureau of Prisons' New York Residential Reentry Management Office, the bureau said in a statement. The Bureau of Prisons said Shkreli's projected release date from federal custody was September 14.
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   Quote Alert

   On This Day Alert

1743 - Jean-Pierre Christin Invents the Celsius Thermometer

Jean-Pierre Christin was a French physicist, mathematician, astronomer and musician. His proposal in 1743 to reverse the Celsius thermometer scale (from water boiling at 0 degrees and ice melting at 100 degrees, to where zero represented the freezing point of water and 100 represented the boiling point of water) was widely accepted and is still in use today.
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  TED Alert

The History of the Barometer (And How it Works)

A barometer is an instrument that measures air pressure, allowing weather forecasters and scientists to better predict extreme weather events. Despite its incredible usefulness, inventing the barometer was no walk in the park. Asaf Bar-Yosef describes the series of scientists and events that contributed to the birth of the barometer -- and explains how it actually works.
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  Poll Alert

If you were looking to buy a house and found one you could afford that you thought met all of your requirements, would you still be willing to buy it if you learned the previous homeowners had been murdered in it?

► Yes
► No

Previous Poll Results:

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  Bioprocess Alert

PID Controls: The Forgotten Bioprocess Parameters

The ambr250 high-throughput bioreactor platform was adopted to provide a highly-controlled environment for a project investigating genome instability in Chinese hamster ovary (CHO) cells, where genome instability leads to lower protein productivity. Development of the baseline (control) and stressed process conditions highlighted the need to control critical process parameters, including the proportional, integral, and derivative (PID) control loops. Process parameters that are often considered scale-independent, include dissolved oxygen (DO) and pH; however, these parameters were observed to be sensitive to PID settings. For many bioreactors, control loops are cascaded such that the manipulated variables are adjusted concurrently.
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Survey Alert

Is continuous bioprocessing Science Fiction or Science Fact today?

► Science Fact
► Science Fiction

Previous Survey Results:

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  Upstream Alert

Relation of Shear Stress and KLa on Bikaverin Production by Fusarium Oxysporum CCT7620 in a Bioreactor

This study involved evaluating the effects of rotational impeller speed agitation (N) and specific air flow rate (Фair) on bikaverin production and on the growth of Fusarium oxysporum employing 11 bench-scale bioreactor assays. The results showed that the maximum bikaverin production (close to 300 mg L−1) was achieved after 48 h of fermentation in rice medium (20 g L−1 milled rice in water) at 28 °C with a volumetric oxygen transfer coefficient (KLa) and shear stress values of approximately 20 h−1 and 17 N m−2, respectively. We reached this combination of parameters using an N of 340 rpm and Фair of 0.935 vvm. These KLa and shear stress values can be used as references when upscaling this process.
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Event Alert

Understanding and Utilizing the Potential of Capacitance Measurement for Process Intensification

Tuesday, June 7th, 2022

We are excited to present a joint webinar between Aber and Sartorius that will cover the use of dielectric spectroscopy (capacitance measurements) in process intensification. The presentation will start with a perspective of how PAT improves a bioprocess, followed by an introduction to Process Intensification. The audience will be introduced to the full potential of the Sartorius BioPAT Toolbox for Process Intensification, the presentation will then focus on capacitance technology, how it works and the typical applications for which it has been used successfully.
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 Downstream Alert

Leveraging High-Throughput Purification to Accelerate Viral Vector Process Development

Due to the unique challenges related to viral vector purification, implementing HTP approaches for gene therapy process development has not been explored extensively. In this paper, we established a HTP chromatography platform and demonstrated its capability to facilitate gene therapy purification process development using both mini-columns and self-packed resin plates. The end-to-end development workflow for AAV HTP purification is detailed in this work with the expectation of serving as an introductory for the AAV purification development field. Comparable process performance was confirmed between a bench-scale chromatography process and an HTP chromatography format. Slightly lower recovery was observed using the HTP format (62% vs 75%), as well as %full capsid enrichment (71% vs. 82%).
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  Podcast Alert

Artificial Banana Flavor

In the Watermelon episode, Chuck and Josh stumbled into a bit of little-known history about why artificial banana flavor doesn’t taste like bananas. Turns out it does; it just tastes like a banana you’ve probably never eaten.
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  Fill/Finish Alert

Development of Syringes and Vials for Delivery of Biologics: Current Challenges and Innovative Solutions

Several new biopharmaceutical dosage forms have developed over time, such as lyophilized vial, liquid vial, and liquid prefilled syringe formulations. This review summarizes major pharmaceutical dosage forms and their advantages, disadvantages, and countermeasures against the shortcomings of each formulation. The appropriate combination of active pharmaceutical ingredients, excipients, and containers should be selected for the safe and less burdensome administration to the patients. Finally, we note certain opinions on the future development of not only therapeutic proteins but also gene therapeutics.
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  Regulatory Alert

User Fee Reauthorization Bill Advances in the House, Senate Eyes Different Riders

The House Energy and Commerce committee voted unanimously to send legislation to reauthorize the US FDA’s user fee programs to the floor in a 55-0 vote. The bill has significantly different riders from one proposed in the Senate because of severe time constraints, according to an industry source with extensive legislative Hill experience. It was passed by the committee to be picked up for a final vote on the House floor a day after its sister bill was proposed in the Senate Health, Energy, Labor and Pensions (HELP) committee. While some riders in the two bills overlap, a significant number of them don’t.
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  Discovery Alert

Researchers Magnify Hidden Biological Structures with MAGNIFIERS

A research team from Carnegie Mellon University and Columbia have combined two emerging imaging technologies to better view a wide range of biomolecules, including proteins, lipids and DNA, at the nanoscale. Their technique, which brings together expansion microscopy and stimulated Raman scattering microscopy, is detailed in Advanced Science. Unlike fluorescent microscopy, stimulated Raman scattering microscopy (SRS) visualizes the chemical bonds of biomolecules by capturing their vibrational fingerprints. In this sense, SRS doesn't need labels to see the different types of biomolecules, or even different isotopes, within a sample. In addition, a rainbow of dyes with unique vibrational spectra can be used to image multiple targets.
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  Project Alert

Southern Research Breaks Ground on $84 Million Biotech Center

Southern Research has broke ground on an $84 million biotech center in Birmingham on the former site of the now-demolished Quinlan Castle, an abandoned apartment building. The new facility at the corner of Arrington Boulevard (21st Street) and Ninth Avenue South is expected to create about 150 new jobs. The center will be a hub of scientific research for Southern Research scientists and UAB scientists to work on treatments for cancer, COVID-19 and other diseases. Southern Research, which was founded in 1941 as a non-profit scientific research organization that employs 250 scientists and staff, plans to update and renovate its campus. The new biotech center will have space to host biotech start-up companies.
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  Patent Alert

Automated Integrated Continuous System and Bioprocess for Producing Therapeutic Protein

A U.S. Patent Application for an "Automated Integrated Continuous System and Bioprocess for Producing Therapeutic Protein" from Enzene Biosciences was published on March 24th, 2022. The present invention provides an automated integrated continuous bioprocess system and bioprocess for producing therapeutic protein, in which the system and process is controlled with one or more control system selected from supervisory control and data acquisition (SCADA) control system (110), proportional integral derivative (PID), programmable logic circuit (PLC), industrial PC (IPC), distributed control system (DCS), message relaying system and automated UPLC/HPLC sampling for online testing to run the system and process and in an uninterrupted manner and continuously produce therapeutic protein.
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  Solution Alert

Comparison Guide: Tube Welders and Aseptic Connectors

As we continue, as an industry, to see unprecedented demand in therapies, there is increased demand for efficiencies, speed to market and regulatory transparency. Manufacturers are evaluating all steps in their workflows to determine if improvements can be made; one such area for evaluation should be in your aseptic connections. While tube welders can provide a closed system, review this guide to determine if your process could be enhanced by aseptic connectors.
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  Humor Alert

Dan Reynolds

  Fact Alert

There's a Town in Norway Named "Hell" Which Freezes Almost Every Winter

Hell really does freeze over– at least in the middle of rural Norway it does. On average, for a third of the year, the village of Hell in Norway freezes over, reaching sub-artic temperatures as low as −25 °C (−13 °F) and making it among one of coldest places to live on Earth. Hell is a sleepy post town with a train station, a grocery store, a grill, a gas station and of course, a retirement home. To the average Norwegian, the word Hell actually means luck, but the town’s name stems from the overhanging cliff caves in the area known as hellir in old Norse. Tourists rarely buy a one-way ticket to Hell and usually just jump straight back on the train, continuing onto their next destination without discovering much of the small town.
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   Career Alert

Merck
Scientist, Vaccines Process Research & Development

West Point, PA
The successful candidate will serve as an individual scientific contributor responsible for downstream process development of vaccine candidates encompassing multiple modalities including live/attenuated viruses, nucleic acids, recombinant protein subunits, and polysaccharide-protein conjugates. Learn More

Pfizer
Principal Scientist– Fermentation Process Development

Kalamazoo, MI
The position will work as part of an interdisciplinary team as well as providing scientific leadership to improve Pfizer’s production processes through biotransformation, biocatalysis and microbial culture improvement projects Learn More

Just-Evotec Biologics
MES/Automation Engineer/Sr. Engineer – Technical Operations 

Redmond, WA
The MES/Automation engineer will be part of the Manufacturing Automation team in the Technical Operations organization to support the management and expansion of the PAS-X Manufacturing Execution System used for clinical and commercial manufacturing at Just-Evotec Biologics. Learn More

Eikon Therapeutics
Research Associate, Cell Culture

Hayward, CA
As a cell culture research associate or senior research associate, you will execute cell culture processes to support our technology platform. Primary responsibilities include mammalian cell culture maintenance, expansion and banking for several research programs and HTP automated screening. Learn More

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