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Aspen Alert

Issue # 3366 | January 18th, 2021      

   News Alert

Eric Lander Chosen as Biden’s Chief Science Advisor, Nominated for Cabinet 

President-elect Joe Biden has chosen a pioneer in mapping the human genome to be his chief science adviser and is elevating the top science job to a Cabinet position. Biden nominated Eric Lander, founding director of the Broad Institute of MIT and Harvard, who was the lead author of the first paper announcing the details of the human genome, as director of Office of Science and Technology Policy and adviser on science. He is the first life scientist to have that job. His predecessor is a meteorologist. Saying “science will always be at the forefront of my administration,” Biden said he is boosting the science advisor post to Cabinet level, a first in White House history.
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Thermo Fisher Picks Up Novasep's Viral Vector Business for $878M in Cash

Thermo Fisher has announced the acquisition of Henogen, Novasep's viral vector manufacturing division, for about or $878.2 million (€725 million) in cash. Henogen provides contract manufacturing services from formulation to packaging across two locations in Belgium and maintains over 75,000 square feet of production space and about 400 employees—a recently increased workforce, as the company gears up to support COVID-19 vaccine production. The division will be absorbed into Thermo Fisher’s pharma services business, under its laboratory products segment. Earlier this month, Novasep also sold off its chromatography equipment division to Sartorius, which it described as a disposal aligned with its new core strategy.
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Fujifilm and the Center for Advanced Biological Innovation and Manufacturing Announce $76M in Funding for Manufacturing and Innovation Center

FUJIFILM Corporation and the Center for Advanced Biological Innovation and Manufacturing has announced that it has secured $76 million in financing and signed a lease for a 40,000 square-foot site in Watertown, Massachusetts at The Arsenal on the Charles. The Center will advance research and development in cell and gene therapy, gene editing, immunotherapy, and biotechnology. The industry-academia research and development consortium was established with an equal investment each from Fujifilm, Harvard, MIT, Cytiva, and Alexandria Real Estate Equities to shorten the path to implementation of therapies, and to accelerate the practical application and commercialization of these therapies.
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   Quote Alert

   On This Day Alert

1964 - Beatles First U.S. Chart Appearance 

On January 18, 1964, “I Want To Hold Your Hand” debuted on the Hot 100 Singles Chart at #45. The Beatles’ impact in America cannot be overstated: When the song hit #1 two weeks’ later on February 1, 1964, it became the first of seven #1 singles they achieved in a one-year period, launching both Beatlemania and the British Invasion.
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  TED Alert

How Designing Brand-New Enzymes Could Change the World

"If DNA is the blueprint of life, enzymes are the laborers that carry out its instructions," says chemical biologist Adam Garske. In this fun talk and demo, he shows how scientists can now edit and design enzymes for specific functions -- to help treat diseases like diabetes, create energy-efficient laundry detergent and even capture greenhouse gases -- and performs his own enzyme experiment onstage.
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  Poll Alert

Are young people making the world better or worse? 

► Better
► Worse

Previous Poll Results:

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  Bioprocess Alert

The Gift of Time - Robust Documentation Means Validation Process Savings 

Often a lot of time is spent on documentation and turnover packages for components, equipment, and systems - time spent reviewing what is in the package, making sure all the necessary documents are there, locating missing documents, etc.  Having robust documentation and turnover packages helps to realize time and money savings during implementation of new equipment. Join Sani-Matic's Mark Espland, automation and documentation manager and Chris McNulty, director of business development (Bio-Pharm) as they discuss what a robust documentation package means for end users, particularly in critical cleaning and validation process.
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Survey Alert

Are you comfortable with the supplier consolidation that is occurring in our industry?

► Yes
► No

Previous Survey Results:

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  Upstream Alert

Optimizing Growth Conditions for Sensitive Cell Cultures - Precision Gas Control in Benchtop Bioreactors

Modern pharmaceuticals frequently rely on cell cultures grown in bioreactors or fermenters as part of large-scale manufacturing lines. This is made possible by the development of prototype processes using benchtop equipment to create controllable environments for research and regulatory approval. At the heart of this equipment is control over the gases that influence fermentation and optimize performance.
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Event Alert

Optimization of T Cell Expansion Under Stirred Conditions in Ambr 15 Microbioreactors

Thursday, January 21st, 2021

Julia Hupfeld - Scientist - PD Membrane and Beads Applications,  Sartorius

In this webinar, Julia Hupfield will present data on how T-cell expansion can be easily established in stirred-tank bioreactors using the Ambr®15 Cell Culture for early process development. The Ambr15 in combination with DoE provides the capability to screen and optimize process parameters at the small scale and with high throughput operation in a time- and cost- efficient manner.  The critical process parameters identified can then be used to define process settings at larger scale.
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 Downstream Alert

Endotoxin Removal by 3M Emphaze AEX Hybrid Purifier

The introduction of two small laboratory capsule sizes (BV1R and BV0.3R) for the 3M Emphaze AEX Hybrid Purifier enables the use of this device for endotoxin removal in laboratory applications using peristaltic pumps, as well as using syringe filtration. The laboratory capsules allow for fast and easy processing of small volumes of early stage drug candidates during pre-clinical and early stage clinical studies in animal-based systems, where endotoxin removal is a requirement in order to avoid eliciting an unwanted immune response while still being able to observe drug efficacy.
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  Podcast Alert

Eliminating Security, Privacy, and Regulatory Burdens with Synthetic Data 

There are many reasons why the sharing of medical data that could be used to gain new insight into diseases can be hampered. Privacy concern, regulatory burdens, and the need to manage security risks are among the significant impediments. Syntegra believes it can solve these problems through its artificial intelligence technology that creates synthetic datasets designed to mirror the statistical properties of real datasets while removing all links to the original patients behind the data. We spoke to Michael Lesh, co-founder and CEO of Syntegra, about the obstacles to data-sharing, how synthetic datasets are developed, and why they might accelerate the pace and lower the cost of research.
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  Regulatory Alert

EMA Says Leaked Documents ‘Manipulated’ 

Documents related to COVID-19 vaccines that were unlawfully accessed in a cyberattack against the European Medicines Agency (EMA) and subsequently leaked online were intentionally manipulated, the agency says. The EMA first disclosed the hack in December and said at the time it had launched a full investigation in cooperation with law enforcement and other authorities. Since then, vaccine frontrunners Pfizer and BioNTech and Moderna have released statements acknowledging that documents related to their COVID-19 vaccine submissions were accessed. Now, in its latest update, the EMA has disclosed that the leaked documents included internal confidential email correspondence from November relating to its evaluation processes for COVID-19 vaccines. “Some of the correspondence has been manipulated by the perpetrators prior to publication in a way which could undermine trust in vaccines."
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  Discovery Alert

Model Analyzes How Viruses Escape the Immune System 

One reason it's so difficult to produce effective vaccines against some viruses, including influenza and HIV, is that these viruses mutate very rapidly. This allows them to evade the antibodies generated by a particular vaccine, through a process known as "viral escape." MIT researchers have now devised a new way to computationally model viral escape, based on models that were originally developed to analyze language. The model can predict which sections of viral surface proteins are more likely to mutate in a way that enables viral escape, and it can also identify sections that are less likely to mutate, making them good targets for new vaccines. The study is published in the current edition Science. 
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  Project Alert

Adverum Biotech to Build New Biologics Manufacturing Facility in North Carolina

Adverum Biotechnologies will invest $82.8 million for a new gene therapy manufacturing facility in Durham County, North Carolina. The new facility, which will encompass 174,000 square-feet, will include no fewer than four 1,000 liter bioreactors at the outset and be enabled to support future expansion. For its part, the state of North Carolina and local governments have committed up to $9 million in incentives to Adverum which plans to create 200 jobs. According to published reports the new cGMP manufacturing facility will be ready to manufacture commercial product by 2023.
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  Patent Alert

Removal of Microorganisms from Cell Culture Media

A U.S. Patent for "Removal of Microorganisms from Cell Culture Media " was awarded to MilliporeSigma on December 8th, 2020. The present invention is an asymmetric, porous polyethersulfone membrane having a surface modified with a polymer consisting essentially of randomly arranged and crosslinked monomers of diacetone acrylamide and a non-acrylamide cross-linkable difunctional monomer, wherein the non-acrylamide cross-linkable difunctional monomer is polyethylene glycol diacrylate.
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  Solution Alert

Pilot‐Scale Demonstration of an End‐to‐End Integrated and Continuous Biomanufacturing Process

There has been increasing momentum recently in the biopharmaceutical industry to transition from traditional batch processes to next‐generation integrated and continuous biomanufacturing. This transition from batch to continuous is expected to offer several advantages which, taken together, could significantly improve access to biologics drugs for patients. Despite this recent momentum, there has not been a commercial implementation of a continuous bioprocess reported in the literature. In this study, we describe a successful pilot‐scale proof‐of‐concept demonstration of an end‐to‐end integrated and continuous bioprocess for the production of a monoclonal antibody.
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  Fact Alert

One of Paul McCartney’s most poignant and memorable songs is “Eleanor Rigby,” all about a lonely old woman who dies in a church with nobody to mourn her.

McCartney has always claimed he got the titular name from actress Eleanor Bron, who appears in the 1965 Beatles film Help!, and a shop in Bristol, England, called Rigby & Evens Ltd, Wine & Spirit Shippers. There’s every reason to believe he’s telling the truth. But the world later learned there’s a gravestone for a woman named Eleanor Rigby in Woolton Cemetery, located near St. Peter’s Church in Liverpool, where Paul first met John Lennon in 1957.
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   Career Alert

McFlusion
Sales Director
North America
This person will lead the expansion of our sales order book, bringing the expertise, influence skills, contacts and deep understanding of the industries production processes and related cleaning issues that need to be addressed. Learn More

Abzena
Upstream Process Development Associate I
San Diego, CA
Assists in cell culture production using aseptic techniques and following protocols and procedures to perform process development associated activities. Learn More

DSM
Analytical Biotech Expert, Principal Scientist
Columbia, MD
Our R&D Solutions Analytics team at the DSM Biotechnology Center in Columbia, MD is looking for a Principal Scientist with broad expertise in the area of Analytics and Biotechnology to support the development of innovative nutritional products within an exciting and collaborative research and development environment. Learn More

Genentech
Systems Specialist I
Hillsboro, OR
Provides technical support for Genentech staff. Skilled at providing end user support in a complex, 24x7 environment. Must be able to communicate effectively with technical and non-technical customers. Learn More

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