FDA Widens U.S. Safety Inquiry into AstraZeneca Coronavirus Vaccine

                                                                                          Issue # 3298 | October 1st, 2020     




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News Alert


FDA Widens U.S. Safety Inquiry into AstraZeneca Coronavirus Vaccine

The U.S. FDA has broadened its investigation of a serious illness in AstraZeneca's COVID-19 vaccine study and will look at data from earlier trials of similar vaccines developed by the same scientists, three sources familiar with the details told Reuters. AstraZeneca's large, late-stage U.S. trial has remained on hold since Sept. 6, after a study participant in Britain fell ill with what was believed to be a rare spinal inflammatory disorder called transverse myelitis. The widened scope of the FDA probe raises the likelihood of additional delays for what has been one of the most advanced COVID-19 vaccine candidates in development. The requested data was expected to arrive this week. Learn More




New Thin Film Technology to Revolutionize Storage and Distribution of Biologic Treatments and Vaccines

Jurata Thin Film, a company focused on revolutionizing how biologics are shipped and stored, is bringing to market a new technology that allows biologics and vaccines to be packaged, shipped and stored at room temperature for extended periods of time. The first-of-its-kind technology enables up to 500 doses of vaccine to be placed on a single wafer-thin, 8.5" x 11" sheet of film, weighing one-hundredth of a pound (5g). Known as MSI-TX Thin Film™, the technology represents a fundamental shift in biologic packaging and storage technology that removes the need for specialized storage containers and -80º C (-140º F) freezers that today are required to ship and store biologics. Learn More
 


Plastic-Eating Enzyme 'Cocktail' Heralds New Hope for Plastic Waste

The scientists who re-engineered the plastic-eating enzyme PETase have now created an enzyme 'cocktail' which can digest plastic up to six times faster. A second enzyme, found in the same rubbish dwelling bacterium that lives on a diet of plastic bottles, has been combined with PETase to speed up the breakdown of plastic. PETase breaks down polyethylene terephthalate (PET) back into its building blocks, creating an opportunity to recycle plastic infinitely and reduce plastic pollution and the greenhouse gases driving climate change. PET is the most common thermoplastic, taking hundreds of years to break down in the environment, but PETase can shorten this time to days. Learn More

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Quote Alert


On this Day Alert

1920 Scientific American Reports that Radio Will
         Soon be Used to Transmit Music to the Home



On this day in 1920, Scientific American magazine reported that the rapidly developing medium of radio would soon be used to broadcast music. A revolution in the role of music in everyday life was about to be born. Arguments about radio's origins persist to this day, but its basic workings had been understood for upwards of 20 years at the time of this announcement. Learn More

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TED Alert

The Beautiful, Mysterious Science of How You Hear


Have you ever wondered how your ears work? In this delightful and fascinating talk, biophysicist Jim Hudspeth demonstrates the wonderfully simple yet astonishingly powerful mechanics of hair cells, the microscopic powerhouses that make hearing possible - and explains how, when it's really quiet, your ears will begin to beam out a spectrum of sounds unique to you. Learn More

Poll Alert

Within your lifetime, do you think politics has gotten more or less partisan?

More Partisan
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Bioprocess Alert

Digital Twins and Their Role in Model-Assisted Design of Experiments
 



A major hurdle during process development and optimization studies is the huge experimental effort in conventional design of experiments (DoE) methods. The combination of DoE with a virtual representation of the bioprocess, called digital twin, in model-assisted DoE (mDoE) can be used as an alternative to decrease the number of experiments significantly. In this chapter, digital twins and their role in mDoE are discussed. First, statistical DoE methods are introduced as the basis of mDoE. Second, the combination of a mathematical process model and DoE into mDoE is examined. This includes mathematical model structures and a selection scheme for the choice of DoE designs. Learn More

Market Alert


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Upstream Alert

Improving mAb Manufacturing Productivity by Optimizing Buffer and Media Prep Process Flow



It is common for biologics manufacturing processes to require hundreds of raw materials, ranging from media and media supplements, buffers, and salts to other process chemicals. Buffers and salts are typically the largest constituents by volume used in the downstream processing steps for manufacturing most biopharmaceutical products. The increase in titers and the trend toward continuous biomanufacturing will lead to increased demand in buffer volumes and prep times. To address this gap, strategies for improving mAb manufacturing productivity by optimizing powder and liquid buffer and media prep process flow are worth considering. Learn More

Event Alert


Webinar: To Compress or Not to Compress - What You Need to Know About Packing Resins at Process Scale

Tuesday, October 6th, 2020

Speaker: Dr. Mark A. Snyder, Manager, Process Chromatography, Bio-Rad Laboratories

Join our expert, Dr. Mark A. Snyder, to learn best practices and guidelines for successfully packing different types of chromatography resins. This includes incompressible resins like CHT Ceramic Hydroxyapatite Media as well as traditional compressible resins. CHT is an easy-to-use mixed-mode media and has high specific gravity, a rapid settling rate, and sensitivity to mechanical shear. These variations from traditional compressible resins have to be considered when designing CHT column-packing protocols. Attend this 15-minute webcast and get all your process column-packing questions answered.


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Downstream Alert

The Next Generation of IR Spectroscopy: EC-QCL-Based Mid-IR Transmission Spectroscopy of Proteins with Balanced Detection


We report a mid-IR transmission setup for the analysis of the protein amide I and amide II band in aqueous solutions that achieves a limit of detection as low as 0.0025 mg mL-1, outperforming our previous results and other state-of-the-art mid-IR-based techniques by almost an order of magnitude. This large improvement is made possible by combining the latest-generation external cavity-quantum cascade laser (EC-QCL) operated at room temperature with an optimized double-beam optical setup that adjusts the path length (26 μm) to ensure robust sample handling. Learn More
 
Podcast Alert
 
A Queen of Sorts



In 2012, poker star Phil Ivey pulled off an elaborate baccarat scheme that won him over $20 million and landed him in court. But Ivey had another card up his sleeve - a secretive mastermind named "Kelly" Cheung Yin Sun, who crafted the scheme to get revenge. A Queen of Sorts dives into the world of high stakes gambling, and what happens when a casino underestimates an Asian woman. Learn More

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Regulatory Alert

FDA Widens U.S. Safety Inquiry into AstraZeneca Coronavirus Vaccine


 
The U.S. FDA has broadened its investigation of a serious illness in AstraZeneca's COVID-19 vaccine study and will look at data from earlier trials of similar vaccines developed by the same scientists, three sources familiar with the details told Reuters. AstraZeneca's large, late-stage U.S. trial has remained on hold since Sept. 6, after a study participant in Britain fell ill with what was believed to be a rare spinal inflammatory disorder called transverse myelitis. The widened scope of the FDA probe raises the likelihood of additional delays for what has been one of the most advanced COVID-19 vaccine candidates in development. The requested data was expected to arrive this week. Learn More

Discovery Alert

Plastic-Eating Enzyme 'Cocktail' Heralds New Hope for Plastic Waste


 
The scientists who re-engineered the plastic-eating enzyme PETase have now created an enzyme 'cocktail' which can digest plastic up to six times faster. A second enzyme, found in the same rubbish dwelling bacterium that lives on a diet of plastic bottles, has been combined with PETase to speed up the breakdown of plastic. PETase breaks down polyethylene terephthalate (PET) back into its building blocks, creating an opportunity to recycle plastic infinitely and reduce plastic pollution and the greenhouse gases driving climate change. PET is the most common thermoplastic, taking hundreds of years to break down in the environment, but PETase can shorten this time to days. Learn More

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Project Alert

Serum Institute Selects ABEC for Large-Scale, Single-Use COVID-19 Vaccine Manufacturing



ABEC has announced it is supporting Serum Institute of India by delivering six 4,000L CSR bioreactors for the manufacturing of Novavax' COVID-19 vaccine candidate, NVX CoV2373. Serum Institute, the world's largest vaccine manufacturer by number of doses, will utilize ABEC's single-use technologies to advance a global supply of NVX CoV2373 throughout India and low- and middle-income countries. Serum Institute's new facility will be the largest single-use bioreactor-based vaccine manufacturing line in the world.  ABEC's 4,000L CSR single-use bioreactors are the largest in the industry by a factor of two, allowing Serum Institute to double productivity per unit floorspace and achieve the lowest possible cost per dose. Learn More

Patent Alert

System and Method for Production of On-Demand Proteins in a Portable Unit for Point of Care Delivery


 
A U.S. Patent for a "System and Method for Production of On-Demand Proteins in a Portable Unit for Point of Care Delivery" was awarded to the University of Maryland on September 15th, 2020The present invention is a cell-free bioprocessing system for the production of on-demand synthesized desired target protein, the system comprising: a production module for producing a protein; and a purification module for receiving the protein from the production module and for purifying the protein from reagents, wherein the production module comprises a bioreactor for cell-free based protein expression, wherein the bioreactor comprises a resin column... Learn More

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Solution Alert

A co-worker mentioned that Beckman Coulter has set-up a virtual environment to showcase some of their bioprocessing solutions. I have looked at the various virtual conferences but have not been able to find it. Do you have any information on where I can find this resource?



The virtual environment you are looking for is actually free standing and available in two parts; the first being a Cleanroom and the second being a QC Lab. Among the products featured are particle counters, TOC analyzers, and cell counting/viability analyzers to name just a few. Here is a link to more information and access to the environment;
Fact Alert

Ancient Babylonians Used a Base-60 Positional Number System Instead of Base-10


That's why we have 60 seconds in a minute and 360 degrees in a circle. Learn More

Career Alert

 

Just-Evotec Biologics

Janssen R&D, Bioreactor Scientist, Cell Line Development, Spring House, PA
The bioreactor scientist will be responsible for leading and coordinating team activities for screening the top candidate cell lines in ambr15 and ambr250 bioreactors. Learn More

NewAge-AdvantaPure, Senior Applications Engineer, Southampton, PA
The position will take a lead role in the Applications Engineering group within Product Development and manage customer-specific projects and opportunities. Learn More