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Aspen Alert

Issue # 3447 | May 11th, 2021      

   News Alert

FDA Authorizes Pfizer's Coronavirus Vaccine for Younger Teens 

The FDA this week cleared Pfizer's coronavirus vaccine for emergency use in children 12 to 15 years old, making the shot the first authorized for millions of younger adolescents in the U.S. The agency's decision, which had been expected since Pfizer and partner BioNTech asked in early April for an expansion of the vaccine's authorization, is a significant step and greatly widens the pool of people who can be immunized just as some states are reporting falling demand among adults. A panel of advisers to the Centers for Disease Control and Prevention is scheduled to meet this week to vote on use of the vaccine in 12- to 15-year-olds. A positive recommendation would clear the way for children in the age group to schedule and receive vaccination.
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Flagship Pioneering Announces Launch of mRNA Cousin eRNA with Laronde 

Over the past year, the world at large has become more familiar with mRNA technology thanks to vaccines developed against COVID-19. Now the world will be introduced to a new type of RNA-based medicine called Endless RNA, or eRNA for short. This week, Flagship Pioneering announced the launch of its newest company, Laronde, which aims to pioneer new eRNA-based medication, a new type of drug developed at Flagship Labs by general partner Avak Kahvejian. These types of medications are programmable and capable of providing “long lasting, persistent expression of therapeutic proteins” inside a patient’s body. Flagship is no stranger to working with RNA-based therapeutics. Moderna, one of the pioneers of mRNA, is a Flagship spinout.
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BioNTech to Set Up mRNA Manufacturing Site in Singapore 

BioNTech has said it plans to set up a regional base and new manufacturing site in Singapore so that the biotech can keep pace with demand for its mRNA-based coronavirus vaccine and pipeline products in other disease areas. The German firm said the production facility will be able to produce several hundred million doses of mRNA-based vaccine, depending on the requirements of the specific vaccine. BioNTech, which has partnered with Pfizer to produce its COVID-19 vaccine, said it plans to open a Singapore office and begin construction of the manufacturing facility this year, subject to planning approval. The company expects the to be operational in 2023.
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   Quote Alert

   On This Day Alert

1969 - British Comedy Troupe Monty Python was Formed

Long before they wrote sketches about how to irritate people in restaurants, six comedians went out for dinner at their local curry house and made a decision that would change the course of their lives.
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  TED Alert

The Skill of Humor

Humor is something that transcends most barriers. It is a common unification; a concept understood by all. Despite this, there exists a large portion of the population that does not think they can utilize humor. Andrew Tarvin will show you that everyone can use humor.
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  Poll Alert

Which is closer to your view of how people should generally deal with things in the natural world, like the environment and the climate?

► Learn to adapt to what happens and make the best of it
► Try to do things to shape and change it

Previous Poll Results:

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  Bioprocess Alert

Antibody Capture Process Based on Magnetic Beads from Very High Cell Density Suspension

Cell clarification represents a major challenge for the intensification through very high cell density in the production of biopharmaceuticals such as monoclonal antibodies (mAbs). The present report proposes a solution to this challenge in a streamlined process where cell clarification and mAb capture are performed in a single step using magnetic beads coupled with protein A. Capture of mAb from non‐clarified CHO cell suspension showed promising results; however, it has not been demonstrated that it can handle the challenge of very high cell density as observed in intensified fed‐batch cultures. The performances of magnetic bead‐based mAb capture on non‐clarified cell suspension from intensified fed‐batch culture were studied. 
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Survey Alert

How many different bioprocess tubing suppliers do you prefer to have approved for a given application?

► One
► Two
► Three
► Four or More

Previous Survey Results:

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  Upstream Alert

The Role of Protein Hydrolysates in Prolonging Viability and Enhancing Antibody Production of CHO Cells 

Four independent mAb-producing CHO cell lines were grown in media supplemented with one of seven protein hydrolysates of animal and plant origin. This generated a 7x4 matrix of replicate cultures which was analysed for viable cell density and mAb productivity. In all cultures, a consistent growth rate was shown in batch culture up to 4 to 5 days. Differences between cultures appeared in the decline phase which was followed up to 7 days beyond the start of the cultures. There was a marginal but significant overall increase (x1.1) in the integral viable cell density (IVCD) in the presence of hydrolysate but a more substantial increase in the cell-specific mAb (qMab) productivity (x1.5).
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Event Alert

Benefits of Exhaust Gas Analysis in Cell Culture Processes

Tuesday, May 18th, 2021

Christian Klinger (Roche, Penzberg),
Prof. Ralf Poertner (Hamburg University of Technology) 


On May 18th, we will start the second episode of our "We love science" series, this time focusing on the topic "Benefits of exhaust gas analysis in cell culture processes". What is the use of exhaust gas data? We will show you two up-to-date examples. The session will be opened by Christian Klinger. He will show us how he uses CO2 exhaust data to determine pH and pCO2 in cell culture processes. Prof Poertner will then talk about the use of exhaust gas data in his lab to create digital twins. As usual, we look forward to discussing with you and the speakers afterwards.
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 Downstream Alert

Anion-Exchange HPLC Assay for Separation and Quantification of Empty and Full Capsids in Multiple Adeno-Associated Virus Serotypes 

Gene therapy has entered a new era where numerous therapies for severe and rare diseases are generating robust and compelling clinical results. The rapid improvements in gene therapies over the past few years can be attributed to better scientific understanding of the critical quality attributes that contribute to a safe and efficacious product, as well as a better understanding of the manufacturing processes that are required to yield consistent products, which routinely meet the quality standards required for clinical studies. In that regard, we describe the development of a QC-compatible anion-exchange chromatography method consisting of a modular discontinuous gradient to achieve full baseline peak separation and quantification of empty and full AAV capsids.
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  Podcast Alert

Invention of the Book 

Books are one of humanity’s greatest inventions, but where do they come from? In this classic Stuff to Blow Your Mind two-parter, Robert and Joe explore the history of book technology, from ancient clay tablets and papyrus scrolls to the codex and beyond. 
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  Regulatory Alert

FDA Authorizes Pfizer-BioNTech Vaccine in Children 12-15

The US FDA this week authorized Pfizer and BioNTech’s COVID-19 vaccine for use in adolescents 12 to 15 years of age. The FDA said its decision to authorize the vaccine for the new age group is based on data from 2,260 adolescents ages 12 to 15 enrolled in an ongoing randomized, placebo-controlled Phase 3 trial. Patients were followed for a median of more than two months following their second dose. Common side effects reported in the trial are similar to those reported for adults and include pain at the injection site, tiredness, headache, chills, muscle pain, fever and joint pain.
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  Discovery Alert

Feeling Younger Buffers Older Adults from Stress, Protects Against Health Decline 

People who feel younger have a greater sense of well-being, better cognitive functioning, less inflammation, lower risk of hospitalization and even live longer than their older-feeling peers. A study published by the American Psychological Association suggests one potential reason for the link between subjective age and health: Feeling younger could help buffer middle-aged and older adults against the damaging effects of stress. In the study, published in Psychology and Aging, researchers from the German Centre of Gerontology analyzed three years of data from 5,039 participants in the German Ageing Survey, a longitudinal survey of residents of Germany age 40 and older.
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  Project Alert

Construction of Bharat Biotech’s Vaccine Production Unit Begins 

The construction of Bharat Biotech’s vaccine production unit has started at Adhrua in Bhubaneswar. The required statutory clearances and permissions have also been granted for setting up the unit. Localofficials have been directed to expedite construction of the anchor vaccine production unit and the laying of other critical infrastructure. A target date for completion and commencement of production has been set for June, 2022.
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  Patent Alert

Parallel Assembly of Chromatography Column Modules

A U.S. Patent for "Parallel Assembly of Chromatography Column Modules" was awarded to Cytiva on March 2nd, 2021. The present invention is a parallel assembly of chromatography column modules, the assembly having one common assembly inlet and one common assembly outlet, each column module comprising a bed space filled with chromatography medium and each column module comprises integrated fluid conduits which when the column module is connected with other column modules are adapted to connect the bed space of the column module with the assembly inlet and the assembly outlet, wherein the total length and/or volume of the fluid conduit from the assembly inlet to one bed space together with the length and/or volume of the fluid conduit from the same bed space to the assembly outlet is substantially the same for all bed spaces and modules installed in the parallel assembly.
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  Solution Alert

Silicone Tubing Solutions for BioPharma Applications  - A Manufacturer’s Q & A 

The world’s leading pharmaceutical and medical device companies rely on Freudenberg Medical to deliver an extensive selection of high-quality silicone tubing and fluid processing solutions. Cleanroom manufactured in the U.S. and Germany, Freudenberg Medical offers two different platinum-cured silicone product lines, PharmaFocus® Premium and HelixMark®.
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  Fact Alert

Laughter is the Best Medicine

It’s true: laughter is strong medicine. It draws people together in ways that trigger healthy physical and emotional changes in the body. Laughter strengthens your immune system, boosts mood, diminishes pain, and protects you from the damaging effects of stress. Nothing works faster or more dependably to bring your mind and body back into balance than a good laugh. Humor lightens your burdens, inspires hope, connects you to others, and keeps you grounded, focused, and alert. It also helps you release anger and forgive sooner.
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   Career Alert

Catalent
Associate Manufacturing Technology Specialist
Bloomington, IN
The Associate Manufacturing Technology Specialist will select appropriate equipment and single-use components to perform process and develop technical documentation (e.g., Process Flow Diagrams, Process Descriptions) to describe operation of the process at large scale and more. Learn More

ZymoChem
Head of Fermentation
San Leandro, CA
We are adding a Head of Fermentation to spearhead our new distinct Fermentation Team. This role is a career-defining opportunity to gain experience and skills with hiring & managing a small team along with directly contributing to the successful scaling of ZymoChem’s first products to the commercial level. Learn More

Pfizer
Senior Scientist
Andover, MA
The Senior Scientist, Manufacturing Sciences & Technology (MSAT) Drug Substance role is in support of products and process development for biotherapeutics and vaccines, including antibodies, antibody-drug conjugates, therapeutic proteins, and polysaccharides in commercial operations and late-stage clinical development. Learn More

Levitronix 
Bioprocess Sales Specialist
North-East, US
We are seeking a Bioprocess Sales Specialist to technically and commercially support the Levitronix product lines in the bioprocess industry. This individual will use their knowledge of upstream and downstream bioprocesses to manage and support Biotech accounts in the region. Learn More

Saint Gobain
Production Manager – Single Use Assemblies and Molding
Gaithersburg, MD
The Production Manager for the Single Use Assembly and Molding focused factory is responsible for all aspects of manufacturing of the product line. This includes responsibility for Production, Quality, Engineering and Supply Chain functions. Learn More

Beckman Coulter Life Sciences
Biopharmaceutical Copy Writer
Remote, USA
The Biopharmaceutical Copy Writer will be a part of the Biotechnology Business Unit and support the Global Key Account Management team in researching, crafting and delivering engaging content on key biopharmaceutical workflows. Learn More

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