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Aspen Alert

Issue # 3341 | December 1st, 2020      

   News Alert

Protein Folding AI Solves 50-Year-Old Biotech Challenge

This week, DeepMind and the organizers of the long-running Critical Assessment of protein Structure Prediction (CASP) competition announced an AI that promises to redefine biotechnology. The AI, known as AlphaFold, has predicted the structure of dozens of proteins with a margin of error of just 1.6 angstroms—that’s 0.16 nanometers, or atom-sized. This far outstrips all other computational methods and for the first time matches the accuracy of experimental techniques to map out the structure of proteins in the lab, such as cryo-electron microscopy, nuclear magnetic resonance and x-ray crystallography. These techniques are expensive and slow: it can take hundreds of thousands of dollars and years of trial and error for each protein. AlphaFold can find a protein’s shape in a few days.
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Suspected North Korean Hackers Targeted COVID Vaccine Maker AstraZeneca

Suspected North Korean hackers have tried to break into the systems of British drugmaker AstraZeneca in recent weeks, two people with knowledge of the matter told Reuters. The hackers posed as recruiters on networking site LinkedIn and WhatsApp to approach AstraZeneca staff with fake job offers, the sources said. They then sent documents purporting to be job descriptions that were laced with malicious code designed to gain access to a victim’s computer. The hacking attempts targeted a “broad set of people” including staff working on COVID-19 research, said one of the sources, but are not thought to have been successful.
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Divisions Emerge Among U.S. Officials Over When First Covid-19 Vaccine Doses will be Available — And for Whom

Divisions are emerging among top U.S. officials over when the country’s first Covid-19 vaccine will be authorized — and who should be at the front of the line to get vaccinated. Robert Redfield, the director of the CDC, and others have suggested vaccination of Americans could begin by the end of next week. In their scenario, the FDA will authorize emergency use of a vaccine developed by Pfizer and BioNTech almost immediately after a December 10th meeting of an advisory committee, which is expected to recommend authorization. But the head of the FDA center responsible for any such authorization says that it may take several days or even “a few weeks” before his office gives the vaccine a green light.
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   Quote Alert

   On This Day Alert

1955 - Rosa Parks Ignites Bus Boycott 

In Montgomery, Alabama, Rosa Parks is jailed for refusing to give up her seat on a public bus to a white man, a violation of the city’s racial segregation laws.
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  TED Alert

Three ideas. Three contradictions. Or not. | Hannah Gadsby

Hannah Gadsby's groundbreaking special "Nanette" broke comedy. In a talk about truth and purpose, she shares three ideas and three contradictions. Or not.
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  Poll Alert

Would you support or oppose your state instituting a 1-month lockdown (meaning only essential businesses would be allowed to be open) to limit the spread of the coronavirus? 

► Support
► Oppose

Previous Poll Results:

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  Bioprocess Alert

Insights on Successful Gene Therapy Manufacturing and Commercialization

Inspired by recent FDA gene therapy approvals, technological advances and successful results, the Cell Culture Dish have partnered with industry experts Pall Biotech, Cobra Biologics, SCIEX, REGENXBIO Inc., BioTechLogic and Jane Barlow & Associates, LLC to share their perspectives in a new ebook, 'Insights on Successful Gene Therapy Manufacturing and Commercialization'. This publication identifies the key challenges, new developments, recent successes, and areas for improvement facing the industry.
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Survey Alert

How do you perceive the industry adoption of single-use solutions?

► Growing
► Slowing

Previous Survey Results:

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  Upstream Alert

Monitoring of Heat- and Light Exposure of Cell Culture Media by Raman Spectroscopy: Towards an Analytical Tool for Cell Culture Media Quality Control

Cell culture media are highly complex solutions of multiple nutrients for mammalian cells and lay the foundation for enhanced quality of the expressed protein and the performance of the bioprocess. Especially for long term, large-volume continuous production processes the constant quality of media without compositional variation is desirable, despite exposure to various stress conditions like (UV)-light or (high)-temperature cannot be represented by a measurable parameter yet. In this study, chemometric analysis of non-enhanced RAMAN spectra was used to identify different cell culture media and to track accelerated degradation conditions by light or temperature in aqueous solutions of glucose and chemically defined media. 
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Event Alert

Advancement in Single-Use Sensor Technology for Mammalian and Microbial Bioprocesses 

Wednesday, December 2nd, 2020

Marcus Bayer, Market Segment Manager, Hamilton Bonaduz AG

The webinar will discuss the immense progress that has been achieved in SUT recently. We are excited to show the capabilities of the newest in-line, single-use pH and dissolved oxygen sensors that improve the measurement and control of bioprocesses while reducing the need for excessive operator oversight or the burden of process intervention at the same time. Our presenters will share data of an integrated solution that offers the tangible benefits of in-situ, pre-irradiated, pre-calibrated, low drift, and long-term dry storage shelf life pH sensors.
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 Downstream Alert

EtoxiClear™ - A Chromatography Adsorbent for Effective Removal of Endotoxins from Biopharmaceuticals

Biomolecules can interact with LPS either by binding to specific sites or by electrostatic/hydrophobic interactions making the separation of endotoxins from proteins difficult to achieve. These interactions can result in interference with endotoxin assays masking the presence or removal of LPS leading to inefficient removal. Many methods have been adopted for the removal of endotoxin based on adsorption, two-phase portioning and chromatography, however these methods often lead to loss of the target protein or introduction of toxic ligand components, such as polymyxin B which has been used for this purpose. This paper addresses the issue of removal of endotoxin from biological preparations. Specific reference will be made to a novel synthetic ligand affinity adsorbent, EtoxiClear™.
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  Podcast Alert

An Astronaut’s Guide to Isolation

Brian Cox and Robin Ince are joined by a stellar panel of space travellers as they get tips on surviving isolation from a group with a truly unique insight. They are joined by astronauts Helen Sharman, Chris Hadfield, Nicole Stott and Apollo 9's Rusty Schweickart to talk Space X, the future of space travel and how a trip to Mars will be the ultimate test of our ability to survive isolation.
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  Regulatory Alert

FDA Pilots Program to Encourage New Drug Development Tools

The US FDA this week announced it will pilot a new program it hopes will spur the development of novel drug development tools (DDTs) that do not fit within the agency’s existing DDT qualification programs. The qualification process for DDTs was revamped under the 21st Century Cures Act and FDA currently offers specific qualification programs for biomarkers, clinical outcome assessments (COAs) and animal models for use under the Animal Rule, which allows for the approval of drugs based on data from animal studies when human efficacy studies are not ethical or feasible. Under the agency’s new Innovative Science and Technology Approaches for New Drugs (ISTAND) program, the FDA says it will offer developers early feedback on proposed DDTs that are “out of scope for existing DDT qualification programs” and provide a path to qualification or other outcomes when qualification is not appropriate.
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  Discovery Alert

Scientists Design Model to Predict Cellular Drug Targets Against COVID-19

A computational model of a human lung cell has been used to understand how SARS-CoV-2 draws on human host cell metabolism to reproduce by researchers at the University of Warwick. This study helps understand how the virus uses the host to survive, and enable drug predictions for treating the virus to be made. Their results are published in the paper, 'Inhibiting the reproduction of SARS-CoV-2 through perturbations in human lung cell metabolic network', in the journal Life Science Alliance.
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  Project Alert

Eisai Invests in New Packaging Lines

Eisai has made a $15.2 million investment to fund two new packaging lines and create new jobs at its Hatfield production plant in Hertfordshire. Following a succession of approvals and reimbursements across the world for its cancer therapy, Lenvima (lenvatinib), Eisai is now expanding its facilities to triple product output within the next three years and is targeting a four-fold increase by 2025 to meet global demand.
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  Patent Alert

Methods and Compositions Comprising Purified Recombinant Polypeptides

A U.S. Patent for "Methods and Compositions Comprising Purified Recombinant Polypeptides" was awarded to Genetech on November 3rd, 2020. The present incention is a method of purifying a recombinant antibody produced in Chinese hamster ovary host cells and having phospholipase B-like 2 (PLBL2) levels greater than 100 ng/mg, wherein the method comprises performing a hydrophobic interaction chromatography (HIC) step and provides a purified preparation comprising the recombinant antibody and a residual amount of hamster PLBL2, and wherein the residual amount of hamster PLBL2 is less than 20 ng/mg. 
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  Solution Alert

Filtration

Modulation of Transmembrane Pressure in Manufacturing Scale Tangential Flow Filtration N‐1 Perfusion Seed Culture

A high‐density culture was used to inoculate the production stage of a biomanufacturing process. At constant permeate flux operation, increased transmembrane pressures (TMPs) were observed on the final day of the manufacturing batches. Small scale studies suggested that the filters were not irreversibly fouled, but rather exposed to membrane concentration polarization that could be relieved by tangential sweeping of the hollow fibers. Studies were undertaken to analyze parameters that influence the hydrodynamic profile within hollow fibers; including filter area, cell density, recirculation flow rate, and permeate flow rate. Results indicated that permeate flow rate had the greatest influence on modulating TMP. Further evaluation showed a significant decrease in TMP when permeate flow was reduced, and this occurred without any negative effect on cell growth or viability. 
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  Fact Alert

Deland McCullough, a former NFL player and now coach, was given up for adoption at birth in 1973 

He found his birth mother in 2017. She told him the name of his father, who turned out to be his college coach and mentor throughout his adult life.
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   Career Alert

AdvantaPure/NewAge Industries
Manufacturing Director
Southampton, PA
Directs the thermoplastic, thermoset extrusion, molding and assembly manufacturing group in production and development. Provides new technologies to improve existing thermoset and thermoplastic extrusion, molding and assembly. Learn More

Kiniksa Pharmaceuticals
Senior Director, Upstream Process Dev & Mfg
Lexington, MA
This position will provide technical oversight and strategic guidance for all upstream development and manufacturing activities. Learn More

AbSci
LIMS Scientific Lead
Vancouver, WA
The LIMS Scientific Lead will lead and manage the implementation and maintenance of a LIMS system. Learn Mor

Spark Therapeutics
Technology Capital Projects Leader
Philadelphia Area, PA
This role is responsible for establishing and managing the overall project schedules from design through construction, commissioning, qualification and start-up. Learn More

Pfizer
Senior Associate Scientist Bioprocess R&D
Chapel Hill, NC
This person will provide science and technology expertise in the disciplines of macromolecule purification sciences for the development and optimization of vaccine manufacturing processes. Learn More

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