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Aspen Alert

Issue # 3628  |  January 19th, 2022      

   News Alert

Sensorion Hammered as Lead Drug Fails Key Phase II Study

Sensorion saw its shares collapse this week when the tiny French biotech reported that its only clinical-stage drug had failed the primary endpoint on a key Phase II study — its most advanced test for the therapy. Founded with an eye to developing new drugs for hearing loss, Sensorion says SENS-401 (arazasetron) failed to reach statistical significance for improving hearing loss compared to placebo in the 115-patient study. Its shares lost more than 40% of their value after the news hit. Sensorion has two other early-stage studies for the drug underway now, with the rest in preclinical development.
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FDA Needs More Time to Assess Bluebird Bio Gene Therapy BLAs

The U.S. FDA has extended the review period for bluebird bio's BLA for two of its lentiviral vector gene therapies. The first is for betibeglogene autotemcel (beti-cel) for beta-thalassemia. The second is for elivaldogene autotemcel (eli-cel) for cerebral adrenoleukodystrophy (CALD). The BLA for beti-cel has been extended to August 19, 2022, and for eli-cel to September 16, 2022. The extensions are due to the agency requiring more time to review additional clinical data it had requested from bluebird. The information was classified as major amendments, hence the extensions.
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U.S. Would Seek Global Approach to Updating Covid-19 Vaccines, Official Says

If the FDA decides to update Covid-19 vaccines to take better aim at Omicron or other variants, it is unlikely to go it alone. Instead, a senior FDA official told STAT, the agency expects to take part in an internationally coordinated program aimed at deciding if, when, and how to update Covid-19 vaccines. The approach would ensure decisions are not left solely to individual vaccine manufacturers. “We can’t have our manufacturers going willy-nilly [saying], ‘Oh well, the EMA decided they wanted this composition, but FDA wanted that composition,’” the official said, referring to the European Medicines Agency. “So we are very much of the mind that we would like to be part of a more global process in helping to come to what vaccine composition there should be now.”
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   Quote Alert

   On This Day Alert

1839 - Paul Cézanne Born

Post-Impressionist French painter Paul Cézanne is best known for his incredibly varied painting style, which greatly influenced 20th-century abstract art. His art is said to have formed the bridge between late 19th century Impressionism and the early 20th century's new line of artistic inquiry, Cubism. The mastery of design, tone, composition and color that spans his life's work is highly characteristic and now recognizable around the world. Both Henri Matisse and Pablo Picasso were greatly influenced by Cézanne.
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  TED Alert

Why Must Artists Be Poor? 

The arts bring meaning to our lives and spirit to our culture -- so why do we expect artists to struggle to make a living? Hadi Eldebek is working to create a society where artists are valued through an online platform that matches artists with grants and funding opportunities -- so they can focus on their craft instead of their side hustle.
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  Poll Alert

Which of the following statements best applies to your most recent passport?

► I Have a Valid Passport
► I Used to Have a Valid Passport
► I Have Never Had a Passport

Previous Poll Results:

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  Bioprocess Alert

Harnessing the Potential of Machine Learning for Advancing “Quality by Design” in Biomanufacturing

Ensuring consistent high yields and product quality are key challenges in biomanufacturing. Even minor deviations in critical process parameters (CPPs) such as media and feed compositions can significantly affect product critical quality attributes (CQAs). In this regard, machine learning (ML) approaches offer immense potential in handling non-linear datasets and thus are able to identify new CPPs that could effectively predict the CQAs. ML techniques can also be synergized with mechanistic models as a ‘hybrid ML’ or ‘white box ML’ to identify how CPPs affect the product yield and quality mechanistically, thus enabling rational design and control of the bioprocess.
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Survey Alert

How much time do you spend on data administration (recording, searching or transcribing) in a typical week? Please comment on your experience(s).

► 0-5 Hours Per Week
► 5-10 Hours Per Week
► 10-20 Hours Per Week
► Over 20 Hours Per Week

Previous Survey Results:

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  Upstream Alert

New Insights from Locally Resolved Hydrodynamics in Stirred Cell Culture Reactors

The link between hydrodynamics and biological process behavior of antibody-producing mammalian cell cultures is still not fully understood. Common methods to describe dependencies refer mostly to averaged hydrodynamic parameters obtained for individual cultivation systems. In this study, cellular effects and locally resolved hydrodynamics were investigated for impellers with different spatial hydrodynamics. Therefore, the hydrodynamics, mainly flow velocity, shear rate and power input, in a single- and a three-impeller bioreactor setup were analyzed by means of CFD simulations, and cultivation experiments with antibody-producing Chinese hamster ovary (CHO) cells were performed at various agitation rates in both reactor setups.
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Event Alert

Oxidative Monitoring in Fermentation

Thursday, February 24th, 2022

ORP has a major role to play in understanding and reducing productivity gaps induced by hyper-oxygenation and reactive oxygen species (ROS) accumulation that are generally observed when scaling-up a process from the bench to the manufacturing floor. During this seminar you will learn how the ORP (external redox) during a fermentation can impact not only the growth rate of the cell population but also the expression model and quality attributes from batch to batch.  Some examples at various scales and different strains will be explained under various culture process models from strict anaerobic conditions to highly aerobic models.
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 Downstream Alert

Continuous Background Correction of Refractive Index Signal to Improve Monoclonal Antibody  Concentration Monitoring During UF/DF and SPTFF Operations

Inline refractive index (RI) has the potential for monitoring protein concentration during final bulk concentration. While useful for monitoring and controlling product concentration, RI is sensitive to the respective background buffer being used for processing. This raises concerns around variations in buffer preparations, and during diafiltration where the buffer background is a mixture of different buffers during exchange. This study evaluated whether the use of a RI probe in the permeate line could facilitate continuous background subtraction (dual RI) and improve concentration monitoring during ultrafiltration/diafiltration and single pass TFF concentration for IgG1 and IgG4 antibodies.
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  Podcast Alert

Genomic Testing for Precision Oncology, Shawn Leland, Founder and CEO, Elevation Oncology

Shawn M. Leland is the Founder and Chief Executive Officer of Elevation Oncology overseeing all day-to-day operations. Shawn brings over a decade of experience in medical affairs and business development for the pharmaceutical/biotech industry, with a focus on building collaborations to realize the full potential of targeted and personalized therapeutics. Shawn has been involved in global transactions totaling more than $450 million in upfront payments and milestone payments at Eli Lilly, ARIAD Pharmaceuticals, Argos Therapeutics and Verastem Oncology. Shawn has also served as an expert strategic consultant for Catenion providing guidance on portfolio management for pharmaceutical/biotech companies.
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  Fill/Finish Alert

Physicochemical Factors of Bioprocessing Impact the Stability of Therapeutic Proteins

This review intends to undertake systematic descriptions of the key physicochemical factors in upstream and downstream bioprocesses and correlating their implications with the unfolding and aggregation of therapeutic proteins. The present review highlights the impacts of environmental, chemical and mechanical factors of the bioprocessing on the stability/aggregation of therapeutic proteins. The present review offers insight into this important phenomenon, which will be helpful for real-world challenges in the bioprocess and bio-therapeutic industries.
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  Regulatory Alert

Califf Previews Priorities If Confirmed as FDA Commissioner

In correspondence with two Republican senators before his nomination was advanced in the Senate last week, FDA Commissioner-nominee Robert Califf committed to promoting the use of real-world evidence (RWE) and cited the need for better postmarket evidence generation. Califf said that part of his agenda will be to develop additional systems and policies for RWE and real-world data (RWD) and that FDA should “continue considering RWD/RWE that is fit-for-purpose.” The former commissioner pointed to existing FDA initiatives and recent draft guidance on the use of RWE in drug development and cited the need for improved post-market evidence generation.
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  Discovery Alert

Polish Scientists Find Gene That Doubles Risk of Serious COVID

Polish scientists have found a gene that they say more than doubles the risk of becoming severely ill with COVID-19, a discovery they hope could help doctors identify people who are most at risk from the disease. With vaccine hesitancy a major factor behind high coronavirus death rates in central and eastern Europe, researchers hope that identifying those at greatest risk will encourage them to get a shot and give them access to more intensive treatment options in case of an infection. The researchers from the Medical University of Bialystok found that the gene was the fourth most important factor determining how seriously a person suffers from COVID-19, after age, weight and gender.
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  Project Alert

Horizon Therapeutics Plans Big Expansion in Rockville, Maryland

Fresh off one of the largest acquisitions in the D.C. area last year, Dublin-based Horizon Therapeutics will make Maryland’s Montgomery County its U.S. East Coast hub, with the signing of a full-building lease in Rockville. Horizon Therapeutics will occupy 192,000 square feet at the new Alexandria Center at the Traville Gateway, in the first of what will eventually be several buildings at the 18-acre life sciences campus. The biopharmaceutical company will start occupying its new building in 2023. Alexandria Center, being developed by California-based Alexandria Real Estate Equities Inc., will eventually increase Montgomery County’s life sciences capacity by more than 500,000 square feet.
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  Patent Alert

Particle Settling Devices

A U.S. Patent for "Particle Settling Devices" was awarded to Sudhin Biopharma on October 19, 2021. The present invention relates to settling devices for separating particles from a bulk fluid with applications in numerous fields. The particle settling devices of the present disclosure may include a stack of truncoconical cones that may be arranged in opposite orientation, apex to base. Other embodiments include several concentric vertical tubes attached to conical surfaces at the bottom, with inclined settling strips attached to the vertical tubes in annular regions between the tubes. These devices are useful for separating small (millimeter or micron sized) particles from a bulk fluid with applications in numerous fields, such as biological (microbial, mammalian, plant, insect or algal) cell cultures, solid catalyst particle separation from a liquid or gas and waste water treatment.
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  Solution Alert

Cell Culture Bioprocess Scale-Up Workflow from Bench to Pilot/Production Scale Using Single-Use Bioreactors

To streamline scale-up, bioengineers commonly use bioreactors with similar geometries at all scales and keep one or more parameters constant between vessels of different sizes, such as kLa, power input per volume or tip speed. Therefore, to design a scale-up strategy, data on scale-up-relevant engineering parameters need to be available for each bioreactor planned to be used. In this webinar we showcase scale-up of an antibody production process in CHO cells from bench to pilot/production scale. We discuss strategies to prepare seed cultures of reproducible quality in shake flasks. We demonstrate a new concept for software-aided scale-up strategy design, which considers vessel parameters of differently sized Eppendorf BioBLU® Single-Use Vessels and Thermo™ HyPerforma™ Single-Use Bioreactors.
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  Humor Alert

  Fact Alert

There is a Blind Man Who Was Born Without Eyes, Yet Can Paint Using Color, Scale, and Perspective

Esref Armagan is a Turkish painter who was born blind. Even though he has never seen anything before, he as a remarkable ability: he can draw and paint landscapes in perspective. In 2004, impressed by his genius, Harvard University, invited him for brain and eye scans. The results of those tests surprised the scientists: the brain’s visual cortex, basically dark in the visually impaired, lit up when Esref touched an object and began drawing.
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   Career Alert

Sartorius
Product Specialist, Chromatography Hardware

Remote, U.S.
As the Product Specialist, you will act as the subject matter expert for technical knowledge of hardware and systems within Chromatography in an effort to drive and optimize commercial activities and sales results with our customers. Learn More

Pfizer
Senior Scientist, Process Development (NMR)

Pearl River, NY
As a Senior Scientist, you will be at the center of our operations and you’ll find that everything we do, every day, is in line with an unwavering commitment to quality. You will be part of a group in Pfizer comprises experts in the major scientific disciplines involved in the development of vaccines. Learn More

Eli Lilly
Principal Research Scientist – Protein Expression Lead

San Diego, CA
We are looking for a goal-oriented leader with supervisory experience, and solid practical knowledge in the general subject areas of recombinant gene expression, molecular biology, biological chemistry, cell biology, or structural biology. Learn More

Bristol Myers Squibb
Lead Automation Engineer

Devens, MA
The ideal candidate will function as the DeltaV Subject matter expert and support the operation of all GMP and non-GMP control systems and other auxiliary equipment at the Devens CTF facility. Learn More

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