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Aspen Alert

Issue # 3474 | June 17th, 2021      

   News Alert

CureVac's COVID-19 Vaccine Misses the Mark with 47% Efficacy 

Preliminary data from CureVac's first-generation mRNA candidate vaccine showed that it was only 47% effective at preventing any severity of COVID-19. The company said that the shot, which the European Commission signed up to buy an initial 225 million doses of late last year, had failed to meet the prespecified measure of statistical success in a phase 2b/3 study. The 40,000-subject trial, spanning Latin America and Europe and conducted with help from Bayer, will still continue on to a final analysis in "the next few weeks," and the company said the initial data has been delivered to the European Medicines Agency. The price of CureVac shares tanked more than 50% in after-hours trading following the news.
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U.S. Buys 200 Million More Moderna COVID-19 Vaccine Doses

The U.S. government has bought another 200 million doses of Moderna's COVID-19 vaccine, the drugmaker said, including an option to buy experimental shots that may be in development. The additional Moderna doses, which brings total U.S. orders to 500 million, could be used for primary inoculation, including of children, or as a possible booster shot, the company said. The U.S. government last August signed a $1.53 billion deal with Moderna for 100 million vaccine doses, with an option to buy 400 million more. The company has filed for a full U.S. approval of the COVID-19 vaccine currently being used and has also asked regulators to authorize its emergency use in adolescents aged 12 through 17.
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Yposkesi Launches Construction of Its Second Bioproduction Site in France

Yposkesi has announced the launch of project SKY, the construction of Yposkesi’s second commercial cell and gene therapy facility in France. Backed by SK Pharmteco, Yposkesi is investing roughly $71M in the 50,000 sq. ft. site, making it one of the largest ATMP facilities in Europe. With this new state-of-the-art facility, designed for European and American GMP compliance, Yposkesi will double its production surface to 100,000 sq. ft. Construction began on May 25, 2021 on a site adjacent to Yposkesi’s current commercial facility. By 2023, equipment consisting of several 1000L bioreactors, chromatography and purification skids will be installed.
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   Quote Alert

   On This Day Alert

2021 – Today Is “ Eat Your Vegetables” Day

There are so many things to consider when it comes to improving your life and having a balanced and healthy diet. Eat Your Vegetables Day is dedicated to getting people eating their veggies, and also in spreading awareness of their diversity and necessity in a healthy diet. The easiest way to celebrate “Eat Your Vegetables Day” is to ensure that vegetables play a major role in your diet for the day.
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  TED Alert

Let's Talk About Ugly Vegetables and Fruits 

Billions of pounds of produce are thrown away every year for cosmetic imperfections! These ugly fruits and vegetables are perfectly fresh and delicious, but their destiny is a trip to the local landfill. This waste costs our economy tens of billions of dollars a year! Mike Meinhardt discusses food waste, imperfect produce, consumers perception of what perfect produce should look like and some underdogs that have come to save the day.
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  Poll Alert

Do you think it is safe for the Summer Olympic Games to be held this year, or should they be postponed another year due to COVID-19?

► Held this Year
► Postponed Another Year

Previous Poll Results:

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  Bioprocess Alert

Estimating Capital Investment and Facility Footprint in Cell Therapy Facilities 

Estimations of the facility footprint and fixed capital investment (FCI) of cell therapy (CT) facilities need to consider the unique features of the single-use technologies (SUTs) selected for CT manufacture (e.g. cleanroom containment requirement, capacity, automation) and the product nature that impacts scale-out versus scale-up approaches. A novel detailed factorial methodology is proposed for estimating FCI and footprint for bespoke stick-built cell therapy facilities that accounts for technology-specific factors for key cell culture technologies as well as the implications of SUTs, open versus closed operations and the commercialisation scenario selected. This study can be used to predict the commercial FCI and facility footprint during early stages of process development.
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Survey Alert

Which of these features most influences your selection of a mass flow meter/controller for the measurement of your bioprocess gases?

► Backflow Alarm
► Digital Communication
► Flow Totalization
► Turn-Down Ratio
► Other

Previous Survey Results:

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  Upstream Alert

CHO Cell Productivity Improvement by Genome-Scale Modeling and Pathway Analysis: Application to Feed Supplements 

Effective bioprocess development using Chinese hamster ovary (CHO) cells as hosts is hampered by the limited understanding of cellular metabolism under process conditions in bioreactors. Systematic tools such as genome-scale models have been developed, but their value has not been satisfactorily demonstrated and exploited for process development. In this study, we proposed a method using a genome-scale model to analyze existing process studies for bioprocess optimization. First, we used existing industrial CHO cell culture experiments to systematically gain metabolic insights for bioprocess development. Two fed-batch cultures, using the same cell line and process, resulted in different titers by supplementing two different types of feed media.
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Event Alert

Are You Ready for Biopharma 4.0? Accelerating Your Cell Culture Development with BioPharma Lifecycle Management 

Tuesday, June 22nd, 2021

Unjulie Bhanot, Solution Owner for Biopharma Development, IDBS

The journey towards this vision starts with improving process understanding and characterization, supported by advances in technology such as high throughput process development as well as advances in data sciences that enable in-silico process development. In this session IDBS will share how effective biopharma lifecycle management can drive speed and innovation in cell culture development as labs struggle with the increases in data from equipment, instruments and sensors.​
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 Downstream Alert

Analysis and Optimal Design of Batch and Two‐Column Continuous Chromatographic Frontal Processes for Monoclonal Antibody Purification

The increasing demand for efficient and robust processes in the purification of monoclonal antibodies (mAbs) has recently brought frontal chromatography to the forefront. Applied during the polishing step, it enables the removal of high molecular weight aggregates from the target product, achieving high purities. Typically, this process is operated in batch using a single column, which makes it intrinsically subjected to a purity‐yield tradeoff. This means that high purities can only be achieved at the cost of lowering the product yield and vice versa. Recently, a two‐column continuous implementation of frontal chromatography, referred to as Flow2, was developed. In this study, we developed an ad hoc design procedure (DP) suitable for the optimization of both batch frontal chromatography and Flow2 in terms of purity, yield, and productivity. 
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  Podcast Alert

The Great Wave 

For centuries, sailors have told stories of mountainous killer waves that rise out of the ocean without warning. Join Robert and Joe for a discussion of the history and science of rogue waves.
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  Regulatory Alert

PIC/S Looks to Adopt EU Annex on Qualified Persons, Batch Release

The Pharmaceutical Inspection Cooperation Scheme (PIC/S) this week announced plans to incorporate the EU good manufacturing practice (GMP) Annex 16 on batch release by a qualified person (QP) into a PIC/S guideline. The aim is to have non-EU/European Economic Area (EEA) members incorporate Annex 16 into their regulatory systems. The EU’s Annex 16 covers the certification of a QP that can release product batches for marketing authorization holders in the EU or labeled for export, and also covers investigational drugs. The QP certifies that a drug has been manufactured in accordance with the marketing authorization and adheres to good manufacturing practices.
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  Discovery Alert

Compounds Derived from Hops Show Promise as Treatment for Common Liver Disease

Research by Oregon State University suggests a pair of compounds originating from hops can help thwart a dangerous buildup of fat in the liver known as hepatic steatosis. The findings, published this week in eLife, are important because the condition affects roughly one-fourth of people in the United States and Europe. While heavy drinking is often associated with liver problems, people with little or no history of alcohol use comprise that 25%, which is why their illness is known as non-alcoholic fatty liver disease, or NAFLD.
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  Project Alert

Fall Opening Expected for ECU Life Sciences & Biotech Building 

East Carolina University in Uptown Greenville is nearing completion of construction on its new Life Sciences and Biotechnology building. As of right now, the building is on track to open this fall. The building is four stories tall, has over 141,000 square feet of space, and will be the home for the ECU Department of Biology and ECU researchers. Some of the programming in the building will include bioprocessing, bioimaging, and optical physics.
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  Patent Alert

Method for Reducing Ammonium and Lactate Production in CHO Cells 

A U.S. Patent for a "Method for Reducing Ammonium and Lactate Production in CHO Cells" was awarded to Danmarks Tekniske on March 30th, 2021. The present invention is a relates to modified producer cells for improved production of therapeutic proteins. Specifically, the inventors have found that removing genes involved in amino acid catabolism in Chinese Hamster Ovary (CHO) cells improves the cell growth and viability and likely also the yield of a recombinant therapeutic protein produced by the cells.
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  Solution Alert

The Good and the Bad Impurities: Trace Elements 

Within the last few decades cell culture media has evolved from complex serum or hydrolysate containing base formulations to chemically defined, animal component-free or animal origin-free, high performance cell culture solutions. In parallel, the biopharmaceutical industry has increased its expectation regarding lot-to-lot consistency and traceability. These requirements thrust analysis of trace element contamination of cell culture media raw materials into focus. Finally, collection of such data will not only aid in an understanding of current cell culture media characteristics, it will also provide required data to assess reasonably or maintain media performance.
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  Fact Alert

Eating vegetables regularly will boost your immune system

It can also help prevent diseases such as diabetes, hypertension, and cancer.
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   Career Alert

NewAge Industries-AdvantaPure
Director of Sales and Marketing
Southampton, PA
The Director will be responsible for the direction, control, and administration of the sales and marketing processes. This leadership position will assist in developing strategic solutions/marketing strategies while developing a high-performance team and growing market share. Learn More

Obsidian Therapeutics
Principal Scientist, Cell Therapy Process Development
Cambridge, MA
We’re looking for a highly motivated scientist with a strong background in cell therapy and/or process development to help drive the development of multiple cell therapy products in our pipeline targeting cancer. Learn More

Culture Biosciences
Bioprocess Engineer III, Tech Transfer
South San Francisco, CA
Your primary responsibility will be to support and manage customer technology transfer projects for cell culture and fermentation clients as well as support ongoing programs and technology improvements. Learn More

Aldevron Madison
Associate Scientist II, E. Coli Culture
Madison, WI
The Associate Scientist II is responsible for all duties relating to expression of recombinant proteins in bacterial shake-flask cultures and supporting the fermentation team. Learn More

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