Aspen Alert

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Issue # 3325 | November 9th, 2020

News Alert

Inside the Operation Warp Speed Effort to Get Americans a COVID-19 Vaccine

While the rest of the country has been counting votes, an Army general named Gus Perna has been counting doses of vaccine. He is in charge of Operation Warp Speed, the catchy title given to the crash program to inoculate 300 million Americans against the coronavirus by next spring. For those of you longing to reclaim a semblance of your previous life, it may not seem all that speedy, but it is compared to the five to ten years it usually takes to field a new vaccine. Once approved, it will not be a silver bullet. Just as with the annual flu shot, some of us will still get sick. But it should make enough people immune so that the virus runs out of places to go. That would give this country what it badly needs right now – a shot in the arm.
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Combative U.S. FDA Panel Votes Against Biogen Alzheimer's Drug

A panel of outside advisers to the U.S. FDA on Friday voted that a potential Alzheimer’s treatment from Biogen Inc has not been proven to slow progression of the disease, a sharp rebuke to agency staff who earlier this week praised the drug. The FDA still could decide to approve the drug, aducanumab, making it the first new Alzheimer’s treatment in decades. But the group of scientific advisers made their doubts about the treatment clear. Several of the 11 panel members expressed resentment that the FDA’s early view of aducanumab was biased toward a favorable outcome for Biogen. The FDA is expected to make its decision on the drug by March.
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Novo Nordisk to Acquire Emisphere Technologies for $1.35 Billion in Cash

Emisphere Technologies has announced that it has entered into a definitive agreement with Novo Nordisk, whereby Novo Nordisk will acquire Emisphere for $1.35 billion in cash. Novo Nordisk and Emisphere have collaborated since 2007, on Emisphere’s proprietary drug delivery technology Eligen®, which facilitates the enhanced oral absorption of molecules without altering their chemical form, biological integrity or pharmacological properties. Novo Nordisk is currently utilizing Emisphere’s carrier technology under an existing license agreement in its oral formulation of a GLP-1 receptor.
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Quote Alert

On This Day Alert

East Germany Opens the Berlin Wall

On this day in 1989, East German officials opened the Berlin Wall, allowing travel from East to West Berlin. The following day, celebrating Germans began to tear the wall down. One of the ugliest and most infamous symbols of the Cold War was soon reduced to rubble that was quickly snatched up by souvenir hunters. The East German action followed a decision by Hungarian officials a few weeks earlier to open the border between Hungary and Austria. This effectively ended the purpose of the Berlin Wall, since East German citizens could now circumvent it by going through Hungary, into Austria, and thence into West Germany.
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TED Alert

The Cost of Work Stress and How to Reduce It

By some estimates, work-related stress drains the US economy of nearly 300 billion dollars a year - and it can hurt your productivity and personal health too, says wellness advocate Rob Cooke. He shares some strategies to help put your mental, physical and emotional well-being back at the forefront.
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Poll Alert

Do you believe the U.S. Congress will pass a bill for a second COVID-19 stimulus package before 2021?

► Yes
► No

Previous Poll Results:

Bioprocess Alert

A Smart Path for Novel Biologics

Cell culture is at the heart of the production process for many biopharmaceuticals but finding the optimal conditions to maximize yield can be a complex and time-consuming process. Traditional process development relies on costly and labor-intensive set-ups, significantly limiting throughput and the range of experimental conditions that can be assessed. Scientists in Roche Pharma Research and Early Development (pRED) have adopted an alternative approach, combining single-use microbioreactors with advanced automation and analytical platforms to streamline the workflow.
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Survey Alert

How do you record your process development work and data?

► Mostly paper and Excel
► Software packages that come with equipment
► Statistical packages like JMP and Umetrics
► An integrated software platform (LIMS, MES, other)

Previous Survey Results:

Upstream Alert

Upstream Process Development with a kLa Criterion Within the BIOne Single-Use Bioreactor

Modern upstream bioprocess development is evolving. The Quality by Design (QbD) directive by the United States FDA expressed how a simple demonstration of bioprocess functionality should no longer be considered a sufficient capstone for process development. Rather, a higher level of process understanding should be obtained. Such understanding should be established through the execution of robust characterization studies and demonstrated through the engineering of strategic process parameters. Such strategic process parameters are essential for the consistent manufacturing of biological drug substances. Therefore, strategic process parameters are necessary to meet quality standards and support final drug product safety and efficacy.
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Event Alert

Integrated Platform for Scalable, Flexible and Intelligent Upstream Process Intensification

Thursday, November 12, 2020

Gerben Zijlstra, Senior Platform Technology Consultant

The Biopharma industry is challenged by costs pressures, increasing numbers of low volume products with unpredictable demand and the advent of new less stable molecules, like bi-and multi-specifics that may not always be suitable for production in the standard Fed-Batch platforms.

In this webinar, Sartorius will walk you through the product life cycle using a comprehensive toolbox for the development and implementation of intensified upstream processes. The webinar will first highlight the cell line generation service for perfusion compatible cell lines and media along with high cell density cell banking. Subsequently, capabilities and data will be shared on high -throughput Ambr® perfusion and benchtop perfusion development tools, with integrated PAT tools for highly efficient process design and design space mapping. Subsequently, we will share how your process insight will dramatically increase and your scale-up journey will be made simple, using enhanced software tools in combination with commercial scale stirred tank and rocker bioreactors with integrated perfusion capabilities.
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Downstream Alert

Development of Small‐Scale Models to Understand the Impact of Continuous Downstream Bioprocessing on Integrated Virus Filtration

We designed small‐scale virus filtration models to investigate the impact of the extended process times and dynamic product streams present in continuous manufacturing. Our data show that the Planova 20N and BioEX virus filters are capable of effectively removing bacteriophage PP7 (>4 log) when run continuously for up to 4 days. Additionally, both Planova 20N and BioEX filters were able to successfully process a mock elution peak of increased protein, salt, and bacteriophage concentrations with only an increase in filtration pressure observed during the higher protein concentration peak. These experiments demonstrated that small‐scale viral clearance studies can be designed to model a continuous virus filtration step with specific process parameters.
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Podcast Alert

How Book Banning Works

If you want to control the masses, control what they read. After all, books are seeds that germinate new points of view. As a result, the struggle against banning books is contentious and continual.
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Regulatory Alert

FDA Advisory Committee Gives Big Thumbs Down to Aducanumab

An advisory committee to the US FDA handed the agency a resounding thumbs down not only on the Alzheimer’s disease candidate therapy aducanumab, but on the agency’s framing of the questions put before the committee and the contents of its briefing documents. The advisory committee heard from the FDA and from the sponsor, Biogen, in separate presentations, but an integrated briefing document was presented that, in the minds of some committee members, made it difficult to parse out the FDA’s perspective and that of the sponsor. The FDA is not obligated to follow the recommendations of its advisory committees, though it usually does.
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Discovery Alert

New Insights on a Common Protein Could Lead to Novel Cancer Treatments

A new University of Colorado Boulder-led study sheds light on a protein key to controlling how cells grow, proliferate and function and long implicated in tumor development. The findings, published this week in the journal Genes and Development, could lead not only to new therapies for hard-to-treat cancers, but also inform novel treatments for neurological diseases and rare developmental disorders, the authors say. For decades, scientists have known that the protein Cyclin Dependent Kinase 7 (CDK7) plays an instrumental role in helping all cell types transcribe, or decode, the genetic instructions provided by their DNA.
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Project Alert

Lonza Opens Facility for ADC Payload Manufacturing

Lonza has inaugurated the first of two manufacturing suites for antibody-drug conjugate (ADC) drug-linker (payload) manufacturing at the Visp, Switzerland site. This first manufacturing suite handles compounds with occupational exposure levels down to 1ng/m3 and is dedicated to the manufacturing platform for ADC drug linkers. This expansion underlines the strategic position of ADCs in the Lonza portfolio, with the company developing and producing all components of these increasingly important cancer treatments: cytotoxic payloads, antibodies and the required linkers on one site.
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Patent Alert

Reactor Surface Finish Remediation

A U.S. Patent for “Reactor Surface Finish Remediation” was awarded to Lonza on October 20^th, 2020. The present invention is biopharmaceutical processing equipment, comprising: a vessel defining a volume for receiving a proteinaceous processing material, the vessel having an interior reactor surface that is configured to contact proteinaceous processing material when contained within the volume of the vessel, the biopharmaceutical processing equipment further comprising a clean-in-place (CIP) apparatus configured to clean the surface, and wherein the interior reactor surface is made from stainless steel and has a pre-commissioning surface roughness of greater than or equal to about 25 Ra Max.
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Solution Alert

In our group meeting one of my colleagues mentioned a recent webinar that addressed an application that coupled the Agilent 2D-LC with a SegFlow automatic sampling solution. Do you have any information on this event?

I took a look at our event calendar and I think I found it. The title was “Online Monitoring and Control of Upstream Titer, Product Quality and Amino Acid Content Using 2D-LC with SegFlow Interface”. Although the live webinar took place several weeks ago, I was able to identify an On-Demand link which is provided below

Agilent 2D-LC with Segflow Interface

Fact Alert

American Lydia Fairchild gave birth to three children whose DNA didn’t match her own.

While filing for child support, she was charged with benefits fraud until her lawyer helped discover she was a chimera (carries two different sets of DNA)
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Career Alert

CHO Plus
Senior Scientist / Director Cell Engineering
South San Francisco, CA
This is a high-level molecular biologist position with responsibility for cutting edge cell line creation and contact with customers and partners. Learn More

Merck
Associate Director, Engineering Automation
West Point, PA
Manage a professional staff of ~ 14 engineers that provide process automation support to enable reliable and compliant supply of vaccines. Learn More

Aldevron Madison
Scientist III Fermentation, Process Development
Madison, WI
The ideal candidate leads complex projects in the areas of recombinant protein expression and fermentation, with an emphasis on methods development. Learn More

Bionova Scientific
Scientist II Cell Culture
Fremont, CA
This person will actively contribute to the development and technology transfer of projects at the Bionova Scientific West Warren site. Learn More

Kerry
R&D Director, Pharma
Beloit, WI
The role entails managing a technical team with a focus on cell nutrition (cell culture and microbiology) in addition to having functional leadership responsibilities. Learn More

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