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Aspen Alert

Issue # 3583 | November 17th, 2021      

   News Alert

Long-Awaited Cures 2.0 Bill Unveiled

Two years after beginning work on a follow up to the 21st Century Cures Act, Reps. Fred Upton (R-MI) and Diana DeGette (D-CO) this week introduced their Cures 2.0 bill. The 173-page bill, intended to supercharge medical innovation, would provide new funding for programs at the US FDA as well as create the $6.5 billion Advanced Research Projects Agency for Health. The bill is largely similar to the discussion draft and contains a dozen provisions that would affect the FDA, including measures to boost clinical trial diversity, improve the collection of patient experience data in clinical trials, establish two new inter-center institutes within the FDA, and provide grants for novel clinical trial designs and other drug development innovations.
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Moderna Offers NIH Co-Ownership of COVID Vaccine Patent Amid Dispute

The National Institutes of Health (NIH) says it has engaged Moderna in "good faith discussions" to resolve a month’s long dispute over the company's patent application that advocates say could impact global production of the shots. Moderna is offering to share ownership of its COVID-19 vaccine patent with the U.S. government to resolve the dispute, the vaccine maker said, and would allow the Biden administration to "license the patents as they see fit." The company claims it had no choice under the "strict rules" of American patent law to list only its own scientists "as the inventors on these claims." But the National Institute of Allergy and Infectious Diseases disagrees. An NIH spokesperson has declined to comment directly on Moderna's offer, citing "ongoing discussions."
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Berkeley City Council Set to Vote on Agreement for Bayer’s Expansion Plans

Last month in a unanimous vote, Berkeley’s Planning Commission recommended that the City Council approve a proposed extension of its development agreement (DA) with Bayer. The revised agreement sets the stage for the city to attract investments in upwards of 1 million square feet of Bayer biotech infrastructure projects over the next 30 years. The potential new facilities would enable Bayer to advance a pipeline of novel biotechnology-based medicines to patients waiting for new treatment options. Berkeley is expected to reap not only the economic benefits of Bayer’s growing operations, but also a commitment from the global biopharma to invest $33.1 million in the community. The Berkeley City Council is expected to vote on the DA extension on November 30.
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   Quote Alert

   On This Day Alert

1558 - Elizabethan Age Begins

Elizabeth I - the last Tudor monarch - was born at Greenwich on 7 September 1533, the daughter of Henry VIII and his second wife, Anne Boleyn. Her early life was full of uncertainties, and her chances of succeeding to the throne seemed very slight once her half-brother Edward was born in 1537. But in 1558, Queen Mary I, the monarch of England and Ireland since 1553, died and was succeeded by her 25-year-old half-sister, Elizabeth. The two half-sisters, both daughters of King Henry VIII, had a stormy relationship during Mary’s five-year reign.
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  TED Alert

The Fascinating (and Dangerous) Places Scientists Aren't Exploring

We're not doing frontline exploratory science in a huge portion of the world -- the places governments deem too hostile or disputed. What might we be missing because we're not looking? In this fearless, unexpectedly funny talk, paleoanthropologist Ella Al-Shamahi takes us on an expedition to the Yemeni island of Socotra -- one of the most biodiverse places on earth -- and makes the case for scientists to explore the unstable regions that could be home to incredible discoveries.
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  Poll Alert

Do you think people should rinse dishes before putting them in the dishwasher?

► Yes
► No

Previous Poll Results:

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  Bioprocess Alert

How Can the Bioprocess Industry Respond to Cost and Maintain Quality?

The move to continuous bioprocessing has been a major topic for a number of years however, challenges remain despite technological and regulatory progress. Biological drug and therapy developers and manufacturers are under scrutiny regarding pricing and this pressure is passed down to their suppliers to respond positively to these challenges. This article draws attention to the benefits of process intensification which includes –but is not exclusively continuous – and to highlight that a series of steps can be taken to improve process productivity, reduce environmental impact and decrease the cost of therapy manufacture while critically maintaining or even improving product quality.
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Survey Alert

How receptive to new bioprocessing solutions (instruments, equipment, sensors…) are you now vs prior to the challenges associated with the past 18+ months? Please comment on your reason(s).

► More Receptive
► Equally Receptive
► Less Receptive

Previous Survey Results:

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  Upstream Alert

Evaluation of a New Glucose Control Strategy Using CITSens Bio APC for CHO Fed-Batch Application

For the cultivation of cell in research and development, high cell densities and reproducibility are fundamental aims. For that goal a high degree of automation is favorable to reduce the risk of contamination and deviation between batches. As glucose is one of the main energy sources for cells, it is crucial to maintain a constant and controlled automated glucose supply. Therefore, the CITSens Bio APC, a combined system to measure and control the glucose concentration in cell culture applications was used.
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Event Alert

High Performance Liquid Chromatography (HPLC) Training

Monday, November 22 - Friday, November 26, 2021

This course will provide you with the knowledge to understand the purification process and packing methods to get the most from preparative chromatography. These live sessions are virtual versions of our regular face-to-face training. The entire training is broadcast over 4 sessions, on 4 days spaced over 1 week. This course is designed for R&D or production systems users, technicians, engineers, managers, and anyone interested in learning HPLC theory and techniques to develop production processes.
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 Downstream Alert

Hybrid Modeling of Cross-Flow Filtration: Predicting the Flux Evolution and Duration of Ultrafiltration Processes

Cross-flow ultrafiltration is a powerful tool used in bioprocesses to concentrate and separate biopharmaceuticals. However, there is a major challenge for its effective use: the fouling rate and decrease in the permeate flux vary substantially depending on the concentration and characteristics of the incoming feed, which causes variations in the process durations. We developed a hybrid model for use in predicting the flux evolution and duration of cross-flow ultrafiltration processes for various proteins, membrane types, input parameters, and filtration modes. The trained hybrid model is able to determine the process duration with an average normalized root-mean-square error of less than 6.2.
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  Podcast Alert

Addressing the Increasing Demand for Single-Use Technologies and Supply Chain Shortages with Future-Proof Systems

According to a new market research study, the global single-use bioprocessing market size is expected to surpass USD 52.5 billion by 2030 – expanding at a CAGR of 16.1% from 2021 to 2030. The adoption rate and demand for single-use equipment continues to grow due to the many commercial advantages of single-use technologies. This podcast addresses the increased demand for single-use equipment and consumables and how this, coupled with a global pandemic, has led to supply chain shortages, as well as strategies to mitigate supply chain issues in the short and long term.
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  Fill/Finish Alert

Electrostatic Spray Drying for Monoclonal Antibody Formulation

This study explored the feasibility of electrostatic spray drying for producing a monoclonal antibody (mAb) powder formulation at lower drying temperatures than conventional spray drying and its effect on protein stability. A mAb formulation was dried by either conventional spray drying or electrostatic spray drying with charge (ESD). The protein powders were then characterized using solid-state Fourier transform infrared spectroscopy (ssFTIR), differential scanning calorimetry (DSC), size exclusion chromatography (SEC), and solid-state hydrogen/deuterium exchange with mass spectrometry (ssHDX-MS). Particle characterizations such as BET surface area, particle size distribution, and particle morphology were also performed.
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  Regulatory Alert

CHMP Recommends 11 New Medicines for Authorization, Including Two COVID-19 Monoclonal Antibodies

The European Medicine Agency’s (EMA) Committee for Medicinal Products (CHMP) last week recommended 11 new medicines for approval in the EU, including Europe’s first two new monoclonal antibodies for treating COVID-19. The agency also recommended the rejection of a treatment for neovascular (wet) age-related macular degeneration. The CHMP recommended authorizing Celltrion Healthcare Hungary’s Regkirona (regdanvimab) and Roche’s Ronapreve (casirivimab/imdevimab) for treating COVID-19 in adults who do not require supplemental oxygen and are at increased risk of severe disease, according to a separate announcement.
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  Discovery Alert

Study Encourages Cautious Approach to CRISPR Therapeutics

A comprehensive study -- conducted by researchers at Sanford Burnham Prebys, the National Cancer Institute (NCI) and other groups -- has shown that gene editing, specifically gene knockout (KO), with CRISPR-Cas9 can favor cells with mutated forms of genes linked to cancer. The findings highlight the need to monitor patients undergoing CRISPR-Cas9-based gene therapy for cancer-related mutations. The study was published in the journal Nature Communications.
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  Project Alert

Arrowhead Pharma Investing $250 Million to Build Manufacturing Campus in Wisconsin

Arrowhead Pharma planning to build a manufacturing campus costing up to $250 million in Verona, Wisconsin starting this winter. Within the next few months, construction crews for the 108,000-square-foot space hope to break ground on the 13-acre site, located in Verona Technology Park north of the Kettle Moraine Trail. The company’s proposal includes two buildings — an 82,000-square-foot manufacturing space, along with a three-story structure meant for offices and labs.
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  Patent Alert

Arrangement and Method for Calibrating at Least Two Sensors in Parallel

A U.S. Patent for the "Arrangement and Method for Calibrating at Least Two Sensors in Parallel" was awarded to Endress Hauser on August 31, 2021. The present invention is an arrangement for calibrating at least two sensors in parallel, including a data processing unit, especially a measurement transmitter for a multisensor system or a computer, wherein the data processing unit has an interface, via which the at least two sensors are connected via separate transmission lines for transmission of data, and wherein the data processing unit is embodied to perform calibrations of the at least two sensors in parallel and independently of one another.
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  Solution Alert

Phase Appropriate Analytical Equipment and Method Lifecycle Management – Expert Roundtable Discussion

Life cycle management is key in ensuring that analytical procedures that are demonstrated to be fit for the intended purpose remain so throughout a product lifetime. Life cycle management holistically incorporates all of the events that take place over the procedure life cycle. For different products, for different labs, life cycle management can mean different challenges and approaches. In this roundtable discussion experts from Pharmaron will introduce analytical method lifecycle and why is it needed and bring up points of risk-based approach to equipment validation and continuous equipment validation and system retirement. We also hear about the learnings from two case studies in life cycle management, on Equipment lifecycle challenges for advanced analytics and Moving to an improved method for Polysorbate 20 analysis.
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  Humor Alert

  Fact Alert

Queen Elizabeth I's Reign Hasn't Ended in Hollywood. If you Enjoy Royalty & Court Intrigue, You'll Love These Movies & Shows About the Virgin Queen

England's Queen Elizabeth has always been a popular character in Hollywood. There are countless films, miniseries, and television shows that have depicted the historic and famed monarch that brought England into the Golden Age after the oppressive rule of her sisters and Henry VIII before her.
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   Career Alert

Flownamics
Technical Sales Representatives
Various, United States
The ideal candidate will have a bachelor’s degree or relevant experience in biopharma. Responsibilities include travel throughout the assigned territory calling on both existing and prospective customers to promote Flownamics products and services, documenting sales activities and the like. Learn More

Sartorius
Product Specialist, Chromatography Hardware - Remote
Field Application Specialist, Bioprocessing – Chromatography - Remote
Field Application Specialist, Bioprocessing – Chromatography - Remote
New Customer Sales Specialist - Marlborough, MA
Customer Development Specialist - Marlborough, MA
Customer Development Specialist - Fremont, CA
Customer Development Specialist - Remote
Order Process Management Specialist - Bohemia, NY
Order Process Management Specialist - Marlborough, MA
Order Process Management Specialist II - Bohemia, NY
Order Process Management Specialist III - Bohemia, NY

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

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