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Aspen Alert

Issue # 3502 | July 27th, 2021      

   News Alert

Chinese Researcher Returns Home After DOJ Moves to Drop a Spate of Cases 

A year ago, the allegations of espionage against Chinese scientists reached a fever pitch as the US abruptly ordered China to shut down its Houston consulate and, on the same day, announced it had charged four visiting Chinese researchers for concealing their ties to the Chinese military in visa applications. Over the past few days, though, the Department of Justice has moved to drop those cases. “Recent developments in a handful of cases involving defendants with alleged, undisclosed ties to the People’s Liberation Army of the People’s Republic of China have prompted the department to re-evaluate these prosecutions,” Wyn Hornbuckle, a spokesman, told the New York Times without elaborating on the specifics.
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Pfizer, Johnson & Johnson Settle High-Profile Remicade Biosimilar Lawsuit  

For nearly four years, biopharma heavyweights Johnson & Johnson and Pfizer have sparred in court over competitive dynamics of the biosimilar industry, demanding the attention of the industry in a groundbreaking case that had some promise to serve as a bellwether for the future. Instead, the closely-watched battle, in which Pfizer claimed J&J unfairly stifled competition for Pfizer’s once-promising biosimilar Inflectra, has ended quietly. The companies confirmed this week that they have settled their case, with the terms undisclosed. The settlement was first reported by the American Journal of Managed Care.
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PerkinElmer Acquiring BioLegend for $5.25 Billion 

In its largest purchase ever, Massachusetts-based PerkinElmer is dropping a massive $5.25 billion in cash and stock to buy biomedical research tool company BioLegend whose estimated revenues for 2022 are expected in the ballpark of $380 million. With over 700 employees, the company provides antibodies and reagents to biopharma and academic partners for biologics and cell and gene therapies. According to reports, BioLegend’s state-of-the-art San Diego campus will transform into PerkinElmer's new "global Center of Excellence for research reagent content development for the combined company."
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   Quote Alert

   On This Day Alert

National Scotch Day

Observed each year on July 27, National Scotch Day celebrates the iconic whisky. In order to be considered scotch, this classy and distinctive spirit must be made in Scotland. It must be fermented from malted barley, aged in oak barrels for at least three years and have an ABV or alcohol content of less than 94.8%. While most scotch is made with barley, water and yeast; other grains can be included.  All fermentation additives are excluded, per law. There are five distinct classifications of Scotch whisky including single malt scotch, single grain scotch, blended malt scotch, blended grain scotch and blended scotch. Scotch is often identified by the region where it was produced and each region has its own characteristics that influence taste. Despite scotch being made in Scotland, you can enjoy the spirit anywhere. Kilt not required.
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  TED Alert

Whiskey: The Cure for Perfectionism

Alex Castle stumbled upon the idea of being a brewer or a distiller when she was 16. That dream, though, changed and shifted over the years. Faced with challenges, rejection, and disappointment, she kept amending her dreams and growing her expectations. She realized dreams can, and should, evolve.
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  Poll Alert

On the subject of climate change do you think:

► Climate is changing as a result of human activity
► Climate is changing but NOT because of human activity
► Climate is NOT changing

Previous Poll Results:

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  Bioprocess Alert

Evidence-Based Guidelines for Controlling pH in Mammalian Live-Cell Culture Systems

A fundamental variable in culture medium is its pH, which must be controlled by an appropriately formulated buffering regime, since biological processes are exquisitely sensitive to acid–base chemistry. Although awareness of the importance of pH is fostered early in the training of researchers, there are no consensus guidelines for best practice in managing pH in cell cultures, and reporting standards relating to pH are typically inadequate. Furthermore, many laboratories adopt bespoke approaches to controlling pH, some of which inadvertently produce artefacts that increase noise, compromise reproducibility or lead to the misinterpretation of data. Here, we use real-time measurements of medium pH and intracellular pH under live-cell culture conditions to describe the effects of various buffering regimes.
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Survey Alert

COVID concerns have forced some FAT's to be virtual events. Do you see 'virtual' FAT's continuing after the travel restrictions are lifted?

► Yes
► No

Previous Survey Results:

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  Upstream Alert

Impacts on Product Quality Attributes of Monoclonal Antibodies Produced in CHO Cell Bioreactor Cultures During Intentional Mycoplasma Contamination Events 

A mycoplasma contamination event in a biomanufacturing facility can result in costly cleanups and potential drug shortages. Mycoplasma may survive in mammalian cell cultures with only subtle changes to the culture and penetrate the standard 0.2‐µm filters used in the clarification of harvested cell culture fluid. In this report, we studied the changes in the IgG1 product quality produced by CHO cells considered to be induced by the M. arginini contamination events. We observed changes in critical quality attributes correlated with the duration of contamination, including increased acidic charge variants and high mannose species, which were further modeled using principal component analysis to explore the relationships among M. arginini contamination, CHO cell growth and metabolites, and IgG1 product quality attributes. 
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Event Alert

Media Management Fuels Process Intensification

Thursday, July 29th, 2021

The intensification of an upstream typically requires much higher media volume requirements. Scheduling all this extra demand and modeling the additional equipment such that the right utilization, storage, and ergonomics are achieved for both operator and unit operation layout will mean no preparation bottlenecks, cleanroom congestion, and costly over-equipping. As upstream intensification demands more media, the risk of contamination or impact of leaks and failures becomes more evident and expensive. Mitigating these risks with an instrumentation toolbox of pre, point-of-use, and post media preparation checks allows for confidence in this productivity increase.  
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 Downstream Alert

In-Line Detection of Monoclonal Antibodies in the Effluent of Protein A Chromatography with QCM Sensor 

A major drawback of the IgG capture step is the high cost of the protein A resin. For a better utilization of the resin, a continuous multi-column operation was recently proposed. In this method, accurate detection of leaking IgG is crucial to divert the breakthrough fluid from the waste to the next column and prolong the loading step without product loss. The detection of a breakthrough point as a change in UV absorption is based on a relatively small signal addition of IgGs to the bulk signal of host cell proteins. To achieve specificity, we used a quartz crystal microbalance and immobilized protein A as specific ligand on the sensor surface. We integrated the quartz crystal microbalance sensor in-line after the protein A column for real-time detection of IgGs in the breakthrough fluid. We show that this specific IgG detection in the breakthrough fluid can be more sensitive than with the UV detector.
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  Podcast Alert

How Mars Works

Sure today Mars would kill you with its thin, toxic atmosphere and cold desert temperature swings of 100 degrees,but early on it and Earth were practically twins. Find out how the two planets diverged and if there might be life on the Red Planet, in this classic episode.
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  Regulatory Alert

FDA Rejects Incyte Cancer Drug, Asking for More Data to Show Clinical Benefit 

An Incyte drug developed to treat a rare type of anal cancer still has a shot at FDA approval, but the company needs to produce more clinical data from a larger study to support its application. The regulator rejected Incyte’s submission, which was based on data from a Phase 2 study. The complete response letters that the FDA sends to companies are not public. According to Wilmington, Delaware-based Incyte, the correspondence states that the regulator needs to see additional data to demonstrate the drug’s clinical benefit treating patients with squamous cell carcinoma of the anal canal (SCAC) that has advanced or spread. The company said it is reviewing the letter and will discuss the next steps for the drug with the agency.
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  Discovery Alert

New Understanding of Cell Stability with Potential to Improve Immune Cell Therapies 

Research in mice, published in Science Immunology by researchers at the Babraham Institute, UK and VIB-KU Leuven, Belgium, provides two solutions with potential to overcome a key clinical limitation of immune cell therapies. Regulatory T cells have potential in treating autoimmunity and inflammatory diseases yet they can switch from a protective to damaging function. By identifying the unstable regulatory T cells, and understanding how they can be purged from a cell population, the authors highlight a path forward for regulatory T cell transfer therapy.
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  Project Alert

Frontier Medicine Establishing Research Lab in Boston 

Frontier Medicine, a biotech start-up in South San Francisco working on potential treatments for cancer is establishing an R&D lab in the Seaport District of Boston. The new facility will occupy 18,000 sq. ft. in a building on D street. This comes after the company was recently able to raise $88.5 million in venture capital investment.
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  Patent Alert

Cell Culturing System for Cultivating Adherent Cells and Liquid Supply Interface Comprising a Cell Culture Container

A U.S. Patent for a "Cell Culturing System for Cultivating Adherent Cells and Liquid Supply Interface Comprising a Cell Culture Container" was awarded to Hamilton on May 4th, 2021. The present invention relates to a liquid supply interface for a cell culture system for supplying cell cultures found in different cell culture containers with a nutrient medium, wherein the liquid supply interface comprises: a housing defining a flow area; a first connection formation for the liquid-transferring connection of a first fluid line to the housing; a second connection formation formed separately from the first for the liquid-transferring connection of a second fluid line to the housing; a third connection formation formed separately from the first two for the liquid-transferring connection of the housing to a third fluid line; a coupling formation formed separately from the connection formations...
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  Solution Alert

Disposable Flowcell for Spectroscopic Analysis in Bioprocesses 

The US FDA has high regulatory and quality requirements for the development and more importantly production of pharmaceuticals. Ideally, the production process is continuously monitored and recorded noninvasively to allow immediate control action if necessary. There are a multitude of established optical detection systems for classical stainless steel bioreactors using fiber optic probes, light guides, light sources and detectors for absorbance, fluorescence and Raman detection techniques. These systems are steam-sterilizable in place, reusable but are complex and expensive. Such systems are not well suited to use on the growing market of pre-sterilized disposable bioreactors, since there is a lack of sterile interface technology. A novel disposable and pre-sterilized flow cell has been developed, which can be easily connected to disposable bioreactors by sterile tube connections. 
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  Fact Alert

Scotch & Whisky/Whiskey Last Forever… Sort Of

A sealed bottle of whisky can last unopened for a century, if not even longer. Open your bottle and you might be able to keep drinking it for another five years, which is great since you don’t want to drink all that lovely scotch at once.
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   Career Alert

Avid Bioservices
Biomanufacturing Associate (Upstream Cell Culture)

Tustin, CA
The Manufacturing Associate performs multiple aspects of cGMP contract cell culture manufacturing in a multi-product manufacturing facility. This position plays an integral role in ensuring the production and on-time release of quality products. Learn More

Abbvie
Associate Director, Fermentation
Irvine, CA
The primary roles of this position are to independently plan, design, and execute the experiments and develop processes to support protein expression, fermentation, and purification process development of natural and recombinant proteins (including neurotoxin) from bacterial cell cultures at various scales. Learn More

Aldevron
GMP Production Supervisor
Fargo, ND
The GMP Production Supervisor will work daily within Aldevron’s labs performing tasks associated with Aldevron’s GMP services. The GMP Production Supervisor is expected to become familiar with all Aldevron’s products and to be able to perform most tasks associated with the purification of Protein and NeoGMP products. Learn More

Cytovia Therapeutics
Manager/Associate Director, Cell Therapy Manufacturing
Aguadilla, Puerto Rico
This person will be responsible for a manufacturing team performing routine cGMP
manufacture of a diverse portfolio of cell therapies. The individual should be a motivated self-starter eager to contribute to building a manufacturing operation unparalleled in its capabilities and expertise. Learn More

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