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Aspen Alert

Issue # 3574 | November 4th, 2021      

   News Alert

Country by Country, Scientists Eye Beginning of an End to the COVID-19 Pandemic

As the devastating Delta variant surge eases in many regions of the world, scientists are charting when, and where, COVID-19 will transition to an endemic disease in 2022 and beyond, according to Reuters interviews with over a dozen leading disease experts. They expect that the first countries to emerge from the pandemic will have had some combination of high rates of vaccination and natural immunity among people who were infected with the coronavirus, such as the United States, the UK, Portugal and India. But they warn that SARS-CoV-2 remains an unpredictable virus that is mutating as it spreads through unvaccinated populations..
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Bayer Backs a George Church Spinout Trying to Turn Lab-Invented Amino Acids Into a New Class of Protein Therapies

Six years ago, Daniel Mandell appeared on NPR to talk about an invention out of Jurassic Park. As Crichton and Goldblum fans recall, International Genetic Technologies, Inc.’s contingency plan to make sure dinosaurs didn’t escape was to take away their ability to make the amino acid lysine, forcing them to rely on lysine supplements from the park staff for survival. Mandell, a fellow at George Church’s Harvard lab, took the idea a step further. He, Church and a team of scientists engineered a bacteria dependent on an artificial amino acid that didn’t exist anywhere; scientists had invented it. In theory, you could exploit that reliance to make sure genetically engineered organisms didn’t spread outside their intended use. For example, you could use the modified bacteria to clean up an oil spill and then get rid of the bacteria.
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Merck KGaA to Support SaudiVax in Becoming First Developer and Manufacturer of Halal Vaccines and Biotherapeutics in Saudi Arabia

Merck KGaA has announced that it will support SaudiVax Ltd., based in the Kingdom of Saudi Arabia, to design a best-in-class, multi-modality manufacturing facility to localize manufacturing of biologics and vaccines for the MENA region. SaudiVax is positioned to become the first developer and manufacturer of Halal vaccines and biotherapeutics in Saudi Arabia, leveraging Merck's integrated Contract Development Manufacturing Services (CDMO), innovative product offerings and single-use technologies. The first phase of this collaboration will focus on conceptual and equipment selection studies, followed by facility fit-out, consulting, and process development services to enable SaudiVax to achieve self-sufficient cGMP manufacturing that meets international regulatory requirements.
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   Quote Alert

   On This Day Alert

1977 – The Incredible Hulk, Starring Bill Bixby and Lou Ferrigno Airs on TV

The Incredible Hulk’s two-hour pilot movie, based on the Marvel Comics character The Hulk aired on November 4, 1977. The television series established the Hulk's origins and starred Bill Bixby as Dr. David Bruce Banner, Lou Ferrigno as the Hulk, and Jack Colvin as Jack McGee. Since its debut, The Incredible Hulk series has garnered a worldwide fan base.
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  TED Alert

Anger Is Your Ally: A Mindful Approach to Anger

How do we create a healthier relationship with anger? Most of us either stuff our anger or we suddenly find ourselves erupting in rage. In this pioneering talk, Juna Mustad reveals how neuroscience and mindfulness techniques can help us unlock the power of the world's most stigmatized emotion, anger.
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  Poll Alert

Does your mental health have a significant impact on your physical health?

► Yes
► No

Previous Poll Results:

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  Bioprocess Alert

Satisfying the Increasing Need for Flexibility in Bioprocess Equipment

Bioprocess equipment must keep pace with this industry requirement for flexibility down to the components and devices used in building them. To a certain extent, this is already evident by the wide-ranging adoption and implementation of single-use based equipment, in particular, single-use bioreactors. In many cases, a properly designed and configured single-use bioreactor platform has the flexibility to adapt to a variety of processes: “change the process, change the single-use bioreactor bag”. To achieve this at the equipment level, however, there have been limitations associated with how bioprocess gas flow control requirements have been specified and, how mass flow controllers have been designed and documented.
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Survey Alert

Do you expect your budget for next year to be More, Less or the Same as this year?

► More
► Less
► Same

Previous Survey Results:

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  Upstream Alert

Updating the Economics of Biologics Manufacturing with 5,000-L Single-Use Bioreactors, A Paradigm Shift

Learn about the economic and operational advantages of Single-Use Bioreactors (SUBs) for large-scale upstream bioprocessing. In this comparative analysis, the authors review the contribution of bioreactors to manufacturing footprints, associated production time lines and efficiencies, and true cost of goods for the production of biologics. They illustrate how 2,000-L and 5,000-L SUBs, like the 5,000-L HyPerformaDynaDrive SUB, may offer a level of volume efficiency, flexibility, and cost effectiveness not easily found with manufacturing strategies built around 15,000-L SS bioreactors.
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Event Alert

Inline Viral Inactivation for Continuous Processing: Considerations for Process-Scale Implementation

Thursday, November 18, 2021

Elizabeth Goodrich, Head of Process Technology R&D, BioContinuum™ Platform

Coiled flow inverter incubation chambers provide effective means of operating low pH virus inactivation (VI) in continuous mode. Even in well-designed chambers, non-uniform flow profiles result in a distribution of fluid residence time, making robust determination of minimum incubation time critical to ensure product safety. Beyond the chamber, a VI system must include precise titration and stable, accurate pH measurement over extended process durations. Finally, validation of the continuous VI step requires establishment of a qualified scale-down model. In this presentation, we show how we are addressing each of these aspects to increase regulatory and end-user confidence in continuous VI.
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 Downstream Alert

Get the Most Out of Protein A Capture

What are the key considerations when designing your process for the Protein A capture step? Gunnar Malmquist shares the key parameters for both fed-batch and perfusion upstream processes. Gunnar Malmquist focuses on resin design strategies, Quality by Design and PAT, as well as using multivariate data analytics and mechanistic modelling to understand biomanufacturing processes.
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  Podcast Alert

Chronic Pain: Can Our Brains Fix It?

People with chronic pain often struggle with it for years while doctors scour their bodies for the cause. But are we looking in the wrong spot? For some of us, could an answer — and the solution — actually be in our brains? To find out, we talked with Professor Lorimer Moseley, Dr. Javeria Hashmi, and psychologist Alan Gordon.
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  Fill/Finish Alert

Methods for Detecting Protein Phosphorylation

Protein kinases transfer phosphate groups from ATP to serine, threonine, or tyrosine residues on protein peptide substrates, directly affecting the activity and function of the target. Radiolabel studies suggest that approximately 30% of proteins in eukaryotic cells are subject to phosphorylation. This crucial post-translational modification regulates a broad range of cellular activities including the cell cycle, differentiation, metabolism, and neuronal communication. In addition, abnormal phosphorylation events are implicated in many disease states. When assessing phosphorylation, the method of choice may vary depending on many factors including the specific question being asked and availability of specialized equipment or reagents.
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  Regulatory Alert

FDA Reiterates Support for Semi-Distributed Tracing Model Under DSCSA

The US FDA recommends that trading partners use the semi-distributed model to trace drug products though the drug distribution chain because of this model’s flexibility and advantages over other data architecture models. The Drug Supply Chain Security Act (DSCSA) requires that trading partners have these systems in place by November 2023. Connie Jung, acting associate director for policy and compliance in FDA’s Office of Drug Security, Integrity, and Recalls in the Office of Compliance at the Center for Drug Evaluation and Research, discussed this preference and other issues related to DSCSA implementation at a November 1 traceability seminar sponsored by the Healthcare Distribution Alliance.
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  Discovery Alert

Novel Drug Liberates Tumor Vessels to Aid Cancer Drug Delivery

A therapeutic antibody developed by scientists at UCL has been shown to unblock and normalize blood vessels inside cancerous tumors, enabling the more effective delivery of targeted cancer treatments. The findings in mice, published in the journal MED, are the first to demonstrate that inhibiting the activity of LRG1, a protein produced in many tumorous tissues, liberates disorganized angiogenesis (blood vessel formation) -- a leading cause of morbidity in numerous diseases including cancer. Researchers say the novel drug offers the potential to achieve a far better outcome in patients who respond poorly to current standard of care for cancers, including those of the breast, colon, bladder, prostate, and lung.
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  Project Alert

Catalent Investing $230M to Expand in Maryland

Catalent announced a year ago it was putting up $130 million to expand its facility in Harmans, Anne Arundel County, near Baltimore-Washington International Thurgood Marshall Airport. The New Jersey-based company announced this week it will spend an additional $230 million to expand its gene and cell therapy manufacturing suites and support facilities. The move is expected to bring more than 700 additional jobs to the greater Baltimore region, an area that continues to expand its biotech footprint. The campus currently has a state-of-the-art FDA approved facility with 10 commercial-scale manufacturing suites.
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  Patent Alert

Magnetic Mixers

A U.S. Patent for "Magnetic Mixers" was awarded to Global Life Science Solutions on August 24, 2021. The present invention pertains to an axial flux stator is implemented to replace the drive-end magnets and the drive motor. The axial flux stator comprises a control circuit to control the voltage and current provided to the stator, to measure the torque and speed of rotation, and to measure the magnetic flux and magnetic flux density produced by the axial flux stator and impeller magnets, individually or in combination. The axial flux stator comprises a plurality of current carrying elements to produce magnetic flux in an axial direction and drive the impeller.
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  Solution Alert

Solving the Capacity Crisis for Viral Vector Manufacturing

Viral vectors for gene therapy have shown tremendous clinical promise which has spurred a huge increase in demand for manufacturing space, resulting in a capacity crisis. This is currently delaying the commercialization of these gene therapies for which time to market is critical. Integrated solutions for viral vectors designed within modular cleanroom facilities streamline manufacturing and reduce time to market. Pall Biotech and G-CON manufacturing have partnered to design and deploy an integrated manufacturing solution to address the current capacity constraints for viral vector manufacturing.
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  Humor Alert

  Fact Alert

The Entire Cast Of 'Inside Out' Wanted To Be Anger

DISNEY PIXAR'S "INSIDE OUT"

Asked if they had wanted to play any other emotion, Amy Poehler, Bill Hader, Phyllis Smith, and Mindy Kaling all choose the role of Anger (played by Lewis Black).   Although he admitted that the role suited him perfectly, if Black could have picked another emotion it would have been Disgust.
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   Career Alert

Saint-Gobain
Applications Engineer II
Beaverton, MI
In this position, the employee will work with customers in developing innovative Single-Use solutions for Bio/pharmaceutical & Medical applications using Saint-Gobain and other supplied components. Learn More

Sanofi
Principal Engineer, Upstream
Framingham, MA
The successful candidate will work with a group of scientists and engineers responsible for technology transfer mammalian cell culture processes to a diverse network of manufacturing facilities, Lifecycle Management and support of commercial processes. Learn More

Pfizer
Bioprocess Technician (BPT) III
Sanford, NC
The candidate will be responsible for operating equipment, completion of support tasks and at times the oversight of assigned activities, in order to obtain the production plan of record. Primary responsibilities will be related to process support (e.g. cleaning, autoclave, washers, buffer, and media preparation). Learn More

GSK
Associate Scientist - Downstream Process Development
King of Prussia, PA
As an Associate Scientist in Downstream Process Development, you will be a member of a highly skilled team of scientists and engineers responsible for the evaluation and optimization of purification processes. You will be involved in all aspects of the development of purification processes. Learn More

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