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Aspen Alert

Issue # 3591 | November 29th, 2021      

   News Alert

Pfizer Says Former Employee Stole Trade Secrets on COVID-19 Vaccine

In a new lawsuit filed in California, published by Bloomberg, Pfizer says an employee, Chun Xaio Li, uploaded more than 12,000 files, including "confidential Pfizer documents," to a personal Google Drive account and to personal devices. The company says it "has yet to understand the full scope" of the alleged theft thanks to the "sheer number" of documents involved. The company's lawsuit focuses on the COVID-19 vaccine, Comirnaty, and two cancer monoclonal antibodies. Pfizer confronted Li after learning of the "troubling conduct," and she initially "gave the appearance of cooperation," the lawsuit says. Now, though, Pfizer believes Li "misled" the company, going so far as to provide a "decoy laptop" to divert the investigation.
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‘Why Did You Guys Sell Everything?’ Inside the Life-and-Death Struggle to Fund Moderna’s COVID-19 Vaccine

Moderna was launched in 2010 by Noubar Afeyan, a Lebanese-born bioengineer running a biotech-venture firm called Flagship Pioneering. He recruited Stéphane Bancel, a Harvard Business School graduate and native of Marseilles, as Moderna’s CEO. Almost immediately, Bancel felt self-imposed pressure to raise enough money so his company could develop drugs and vaccines based on messenger RNA molecules before rivals caught up. In a few short years, he raised billions of dollars in private sales of the company’s shares and Bancel had emerged as the biotech industry’s smoothest and most effective fundraiser. But there was something about Bancel that raised concerns in parts of the biotech and investment communities.
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New Merck Study Results Raise Questions About its COVID-19 Pill

New study results disclosed by Merck & Co. indicate its COVID-19 pill molnupiravir may not be as effective as the company previously stated, a finding that could change how the FDA and its advisers view the drug at an upcoming meeting. In October, Merck said the drug reduced hospitalizations and deaths by nearly 50% in a large trial among people who had mild or moderate COVID-19. That announcement was based on a preliminary result from 775 trial participants, and the data were so convincing that outside study monitors directed Merck to stop testing early. But the final results from all 1,433 volunteers enrolled in the study, raise questions about the drug's benefit. Overall, treatment reduced the relative risk of hospitalization and death in the trial by 30% versus placebo.
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   Quote Alert

   On This Day Alert

1935 - Erwin Schrödinger First Outlined A Quantum Mechanics Thought Experiment Involving A Cat

On November 29, 1935, Austrian physicist Erwin Schrödinger’s published his extraordinary paper in which he proposed an outrageous thought experiment involving a cat, a box, a radioactive sample, a Geiger counter and a vial of poison. Schrödinger loved animals and had no ill intention in crafting the bizarre imaginary experiment. Rather, he sought to offer a ludicrous example that would highlight gaps in the current theory of quantum mechanics. His intended audience included those such as Einstein who were skeptical of quantum orthodoxy, as well anyone else with an open mind about the theory’s limitations. Indeed his hypothetical situation echoed an earlier idea by Einstein about a keg of gunpowder existing in a mixed quantum state between exploded and unexploded. Any credible theory would resolve the apparent contradiction, the physicists believed.
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  TED Alert

What Can Schrödinger's Cat Teach Us About Quantum Mechanics?

The classical physics that we encounter in our everyday, macroscopic world is very different from the quantum physics that governs systems on a much smaller scale (like atoms). One great example of quantum physics' weirdness can be shown in the Schrödinger's cat thought experiment.
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  Poll Alert

Should high school sports teams have mercy rules?

► Yes
► No

Previous Poll Results:

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  Bioprocess Alert

A Guide to Improving Biotech Processes with Process Mass Spectrometry Gas Analysis

The FDA’s Process Analytical Technology (PAT) initiative promotes improved process understanding by defining Critical Process Parameters (CPP) and monitoring these CPPs, either in-line or on-line. Processes can become more efficient, with reduced over-processing and greater product consistency. Gain productivity by instituting a PAT program that is simple, data rich, and low-risk.
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Survey Alert

Is there a need in our community for a low cost, compact bioprocess controller? Please comment on your reason(s).

► Yes
► No

Previous Survey Results:

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  Upstream Alert

Off-Gas-Based Soft Sensor for Real-Time Monitoring of Biomass and Metabolism in Chinese Hamster Ovary Cell Continuous Processes in Single-Use Bioreactors

In mammalian cell culture, especially in pharmaceutical manufacturing and research, biomass and metabolic monitoring are mandatory for various cell culture process steps to develop and, finally, control bioprocesses. As a common measure for biomass, the viable cell density (VCD) or the viable cell volume (VCV) is widely used. This study highlights, for the first time, the advantages of using VCV instead of VCD as a biomass depiction in combination with an oxygen-uptake- rate (OUR)-based soft sensor for real-time biomass estimation and process control in single-use bioreactor (SUBs) continuous processes with Chinese hamster ovary (CHO) cell lines.
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Event Alert

Troubleshooting in Bioprocessing

Wednesday, December 8, 2021

Ines Hartmann Application Specialist Cell Handling, Eppendorf

In this webinar we will address general and day-to-day challenges in the bioprocessing workflow from shake flask to production and discuss possible solutions. We will initially look on common challenges in reactor set-ups and configurations. What vessel and impeller type are the appropriate one for different culture demands (e.g. shear sensitivity, high oxygen demands), what process parameters control is essential and how the integration of additional analytical tools can help to improve process stability. We will address frequent challenges in cultivation, e.g. how to produce reproducible inoculums in shake flasks, how to prevent contamination in a bioreactor, during transfer or sampling and how to cope with difficulties in cultivation in the bioreactor, e.g. foaming or viscous solutions.
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 Downstream Alert

Design and Optimization of Single Pass Tangential Flow Filtration for Inline Concentration of Monoclonal Antibodies

A number of Single Pass Tangential Flow Filtration (SPTFF) systems have recently been commercialized for inline concentration of monoclonal antibodies and other biotherapeutics, both to resolve bottlenecks in existing processes and as part of the development of integrated continuous downstream processes. The objective of this study was to examine the design and optimization of SPTFF modules using a previously developed mathematical model for the filtrate flux and pressure drop that specifically accounts for the concentration dependence of the antibody viscosity and osmotic pressure as well as the variation of the flow rate and antibody concentration with the position in the long pathlength SPTFF device.
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  Podcast Alert

The Biotech Startup that Became an FBI Target

We are bringing you the complete story of uBiome. It was a biotech company with promise: charismatic leaders, an exciting product and lots of venture-capital funding. So why did the FBI end up raiding its office? And why is the government calling its leaders fugitives? WSJ's Amy Dockser Marcus tells the story of uBiome's spectacular downfall.
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  Fill/Finish Alert

Structural Characterization of Proteins in Solid Pharmaceutical Forms

We started the projected studies by preparing samples, i.e. lyophilizates. We decide to use two different monoclonal antibodies and several different excipients, among them two sugars as stabilizing agents. We employed different lyophilization cycles, one for mAb1 and two for mAb2. Some of the samples of monclonal antibody mAb2 were later subjected to stability studies at 40ºC for three and nine months. For samples of mAb1 we used also different stresses, such as UV light and temperature. Samples were analyzed by spectroscopic methods (Infrared, UV-Vis, Fluorescence and Raman spectroscopy, and solid-state NMR), Circular dichroism, Dynamic differential calorimetry, X-ray diffraction analysis and others.
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  Regulatory Alert

FDA Nomination Slips After Biden Admin Fails to Send Papers to Congress

A plan to speed Robert Califf’s nomination for FDA commissioner through the U.S. Senate next month is on hold after the Biden administration failed to submit the necessary paperwork to Congress in time, three people with knowledge of the matter told POLITICO. The delay means that Califf is now unlikely to get a confirmation hearing until mid-December at the earliest, effectively ruling out the possibility of a full Senate floor vote on his appointment before the end of the year. The timing issue represents the latest complication in a month’s long effort to install a permanent leader atop an FDA that sits at the center of the Covid-19 response and vaccination campaign.
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  Discovery Alert

Gold-Based Cancer Therapy Could Face Competition from Other Substances

The gold complex auranofin has traditionally been used for treating rheumatism but is also being evaluated as a treatment for certain forms of cancer. Researchers at Karolinska Institute in Sweden now show that other molecules that inhibit the same biological system have a more specific effect than auranofin and therefore may have greater potential as cancer therapies. The results have been published in the journal Redox Biology.
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  Project Alert

BeiGene Closes on Property for New U.S. Manufacturing and Clinical R&D Center

BeiGene has announced that it has purchased a 42-acre site at the Princeton West Innovation Campus in Hopewell, N.J. to house a new state-of-the-art manufacturing campus and clinical R&D center. Subject to finalizing the development plans, BeiGene expects to invest several hundred million dollars in the initial phase of construction, in addition to the acquisition of the property, for the state-of-the-art facility that is expected to include up to approximately 400,000 square feet of dedicated commercial-stage biologic pharmaceutical manufacturing, including up to 16,000 liters of biologics capacity, along with clinical R&D and office space. Construction of the initial phase is expected to commence in 2022 and be completed in late-2023 or in 2024.
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  Patent Alert

Packed-Bed Bioreactor Systems and Methods of Using the Same

A U.S. Patent for "Packed-Bed Bioreactor Systems and Methods of Using the Same" was awarded to Corning on September 7, 2021. The present invention is a packed-bed bioreactor system for culturing cells is provided, the system including a cell culture vessel having at least one interior reservoir, an inlet fluidly connected to the reservoir, and an outlet fluidly connected to the reservoir; and a cell culture matrix disposed in the reservoir. The cell culture matrix includes a structurally defined multi-layered substrate for adhering cells thereto, and each layer of the multi-layered substrate has a physical structure and a porosity that are substantially regular and uniform.
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  Solution Alert

Optimizing Control of Pump-Related Biopharma-Production Processes

In this white paper, we will illustrate how a new technology – the integrated pump controller – can be used to optimize pump performance in biotech-manufacturing activities by giving the operator the ability to automatically control such parameters as flow and pressure. This control will make it easier to run simple process steps in biopharma applications more effectively, resulting in better consistency, which is imperative when manufacturing products that must adhere to strict process conditions in order to create a safe, useable end-product.
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  Humor Alert

  Fact Alert

A Cat’s Brain Is Biologically More Similar To A Human Brain Than It Is To A Dog’s

Both humans and cats have identical regions in their brains that are responsible for emotions.
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   Career Alert

Codexis
Associate Director, Upstream Bioprocess Development (BioTx)
Redwood City, CA
We are looking to hire an Associate Director to lead the Biotherapeutics Upstream Bioprocess Development team. In this role you will leverage your technical expertise and leadership skills to lead upstream process development and scale up of recombinant protein productions of biotherapeutic enzymes. Learn More

Abbott Laboratories
Scientist, Technology Development
San Diego, CA
Abbott is currently looking for dynamic individual, Scientist - Technology Development, with a proven track record of innovation in the areas of molecular amplification technologies, protein engineering and/or sample preparation who will help drive the design and development of a novel diagnostic point-of-use platform. Learn More

Flownamics
Technical Sales Representatives
Various, United States
The ideal candidate will have a bachelor’s degree or relevant experience in biopharma. Responsibilities include travel throughout the assigned territory calling on both existing and prospective customers to promote Flownamics products and services, documenting sales activities and the like. Learn More

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

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