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Aspen Alert

Issue # 3580 | November 12th, 2021      

   News Alert

NIH to Assert Legal Claim to Some of Moderna’s Key Covid-19 Patents

The U.S. NIH is doubling down on its right to be credited on some of Moderna’s key Covid-19 vaccine patents, according to Reuters, setting the stage for a legal battle with the biotech firm that could determine the shot’s future price and availability.  A year-long spat over who invented key parts of Moderna’s Covid-19 vaccine, first reported by the New York Times this week, has been simmering between the biotech firm and the NIH. This comes after Moderna, despite years of close collaboration, excluded government-funded scientists from key patent applications covering the shot, insisting its own scientists developed crucial elements of the vaccine.
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Novartis Backed Gamida's Approval Plans for Cell Therapy Hits a Snag with FDA Asking for Manufacturing Data

The FDA is requesting more data from Gamida Cell on the company’s wholly owned manufacturing facility before it can go ahead with asking for approval for its cell therapy. The regulatory agency wants to compare omidubicel data from that plant with records from separate facilities that manufactured the drug for the company’s phase 3 study. Gamida, which is backed by Novartis, earlier this year said its registrational trial showed benefits over umbilical cord blood and passed the bar for that study. The FDA's request came during a pre-BLA meeting during which the agency didn't ask for “additional clinical data to initiate the BLA submission once analytical comparability is demonstrated,” Gamida said in a statement.
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Samsung Biologics to Build New Facility for Genetic Medicines in Songdo

Samsung Biologics has purchased land in Songdo, Incheon, to build a production facility for genetic medicines, the Incheon Free Economic Zone Authority announced. The biopharma firm has signed a deal with the authority, which oversees a plan to develop a bio cluster in Songdo, to purchase 100,000+ sq. ft. (10,000 square meters) of land in the city. The site was put up for sale in June. There, Samsung Biologics is expected to construct a new facility to produce materials and drug platforms for genetic medicines, the authority added. According to published reports Samsung will invest roughly $259 million into the facility. The schedule for the project has construction beginning next year with completion planned for 2023..
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   Quote Alert

   On This Day Alert

1933 – First Known Photo of So-Called Loch Ness Monster Was Taken by Hugh Gray. 

Twenty two years on, Constance Whyte visited Hugh Gray in May 1955 who still had vivid memories of that day in 1933 and also recounted five other times he claimed to have seen the monster over those decades. Whyte's account can be found in her book "More Than a Legend".
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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

Have you used COVID-19 as an excuse to get out of something you did not want to do?

► Yes
► No

Previous Poll Results:

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  Bioprocess Alert

Comparison Between Batch and Continuous Monoclonal Antibody Production and Economic Analysis

This work aims to evaluate the benefits of the continuous process in biopharmaceutical manufacturing of monoclonal antibodies (mAbs). An integrated continuous process is designed and built using a process simulator and compared with a fed-batch process production line. The comparisons are based on cost of goods (COG/g) calculation and sensitivity analysis. The fed-batch process results in operating COG/g of $99/g in mAbs production, whereas the continuous process accounts for $51/g. Because of the smaller footprint and fewer storage tanks required in the continuous process, the facility cost reduced by 66%, compared to the fed-batch process. In continuous production, there is a better utilization of the primary capture resin, which leads to a reduction in consumables cost by 68%.
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Survey Alert

Which of these will be the greatest barrier to the development of mRNA as a suitable technology in the next five years? Please comment on your reason(s).

► Efficacy
► High Cost
► Regulatory Constraints
► Other

Previous Survey Results:

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  Upstream Alert

Effect of Baffle Structure on Flow Field Characteristics of Orbitally Shaken Bioreactor

Disposable orbitally shaken bioreactors have been widely used for mammalian cell culture in suspension. Three kinds of baffle structures: vertical baffle, inclined baffle and horizontal baffle were designed in this work. The flow fields of the shaking bioreactor with different baffle structures were simulated, and the turbulence, dissolved oxygen and shear strain rate of the bioreactor were analyzed. The results showed that the quasi-steady-state flow patterns of the unbaffled shaking bioreactors were broken for the bioreactors with the strengthening effects of baffles. The mixing and the oxygen volumetric mass transfer coefficient (kLa) (simulated results) were improved significantly, and the shear strain rates were also increased greatly for the baffle bioreactors. The shear strain rates of the baffle bioreactors were mainly in the range of 0–20 s−1, and they were still low enough for CHO cell cultures.
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Event Alert

The Search for Funding: What You Should Prepare Prior to Your Pitch

Wednesday, November 17, 2021

Lee Johnson, Patents and Innovations Partner at Wilson Sonsini

In the hunt for financing, once you have done your research and secured VC introductions that lead to meetings, it’s time to prepare for the diligence and pitching stages. It’s vital that company founders prepare a pitch to meet VC expectations and create a compelling intellectual property and patent portfolio that will hold up to VC scrutiny and funding agreements. The steps required to prepare for VC meetings and partnerships can be daunting, so significant planning and preparation is key.
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 Downstream Alert

Two New Capture Options for Improved Purification of Large mRNA

One of the barriers to development of industrial purification platforms for large mRNA has been an inadequate selection of high-performing capture-purification tools. Hybridization-affinity uses a polythymidine (Oligo dT) ligand to base-pair with the polyadenine tail of mRNA. It can be used for capture but it cannot discriminate dsRNA (double-stranded) from ssRNA (single-stranded) and it supports only brief cleaning with 100 mM sodium hydroxide. Traditional anion exchangers elute only mRNA smaller than about 500 bases unless the columns are heated to 50–70°C. Hydrophobic interaction chromatography (HIC) and reverse phase chromatography (RPC) separate ssRNA from dsRNA and short transcripts, but their sensitivity to fouling by proteins and aggregates makes them better suited for polishing than for capture.
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  Podcast Alert

Enabling Process Development for Continuous Bioprocessing: Answering the Call for Small Scale Tools That are Fit for Purpose

In this podcast, we discuss the challenges facing biotech companies as they move their therapeutic candidates through the clinic and on to commercial manufacturing. The priority of speed to market is often at odds with issues around development resources, facility space, and infrastructure for both development and manufacturing. Continuous bioprocessing provides solutions for many of these challenges in certain applications, but to deliver on this promise we need fit-for-purpose tools and technologies to enable process development and provide reliable transfer to commercial manufacturing.
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  Fill/Finish Alert

Volume Dispensing with SONOFLOW® CO.55 and FCS Controller: Fill & Finish Application with Ultrasonic Flow Meter

Historically, a peristaltic pump has been used to dispense a set volume into a vial, bag, or bottle. Dispensing pumps calculate volume based on displacement per revolution or counting internal pulses to determine when the desired volume has been reached. Due to the mechanical action of occlusion, the tubing wears over time. Variation of the suction conditions as liquid level decreases in the filling source, as well as tubing degradation, lead to a drop off in volume dispensed until a re- calibration must be implemented to maintain the required accuracy of volume dispense. Depending on the filling application, every 50-100 dispenses are quality control checked and an “on the fly” pump re-calibration may be implemented to maintain compliance to application requirements.
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  Regulatory Alert

Real World Data Not Ready for Post Approval Prime Time

For drugs and biologics that receive accelerated approval, could information drawn from real-world data sources supplant traditional post approval clinical trials to confirm that the therapies have benefit? Real-world data (RWD) are not yet robust enough to confirm the benefit of drugs awarded accelerated approval based on surrogate endpoints, answered the authors of a recent study. “The findings of this cross-sectional study suggest that none of the 50 [FDA]-required post approval confirmatory trials for therapeutic agents granted accelerated approval between 2009 and 2018 could have been feasibly emulated using currently available claims and/or structured [electronic health record] data,” wrote Yale’s Joshua Wallach and colleagues in a November 9 health policy research letter published in JAMA Network Open.
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  Discovery Alert

Cellular Aging: A Basic Paradox Elucidated

In a study published in Nucleic Acids Research, the team of cancer researcher Francis Rodier, an Université de Montréal professor, shows for the first time that cellular senescence, which occurs when aging cells stop dividing, is caused by irreversible damage to the genome rather than simply by telomere erosion. This discovery goes against the scientific model most widely adopted in the last 15 years, which is based on one principle: telomeres, caps located at the ends of chromosomes whose purpose is to protect genetic information, erode with each cell division. When they get too short, they tell the cell to stop dividing, thus preventing damage to its DNA. Made dormant, the cell enters senescence.
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  Project Alert

Zoetis to Expand Its Manufacturing Capability in Tullamore, Ireland

Zoetis is expanding its manufacturing and development facility in Tullamore, Ireland, which should significantly increase its capacity for producing veterinary monoclonal antibodies (mAbs) over time. These therapeutic biopharmaceuticals are the latest breakthroughs in animal medicine from Zoetis’ innovative pipeline of products. The current Tullamore site supports development and manufacturing services across all phases of biopharmaceutical development and commercialization, including the manufacture of Solensia. The expansion is planning, subject to approvals, to break ground in early 2022 and become fully operational by 2025.
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  Patent Alert

Coating a Bioreactor

A U.S. Patent for "Coating a Bioreactor" was awarded to Terumo BCT on August 31, 2021. The present invention provides for introducing a first fluid into a bioreactor and while introducing the first fluid into the bioreactor, circulating a second fluid with a reagent at a first flow rate through the bioreactor. The bioreactor may be maintained in a first orientation for a first period of time to allow at least a first portion of the reagent to coat the bioreactor. The second fluid may then be circulated at a second flow rate slower than the first flow rate to allow a second portion of the reagent to coat the bioreactor. Introduction of the first fluid may promote coating of the bioreactor by ultrafiltration. The introduction of the first fluid may be stopped. A third fluid may be circulated through the bioreactor to remove a portion of the reagent not coated on the bioreactor.
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  Solution Alert

Analytical Reusable & Single-Use Sensors

The deployment of single-use bioreactors (SUBs) is well established in the bioprocessing industry. SUB technology for mammalian cell culture and microbial cells has achieved major breakthroughs in process safety and reliability to comply with the industry’s strict requirements. This application note explains the differences in operation of pH and DO single-use and reusable sensors when employed in single-use bioreactors. Regardless of whether reusable or single-use pH and DO sensors are selected for your SUBs, METTLER TOLEDO can offer highly reliable sensors of both types. Single-use InSUS 310 sensors for pH, and InSUS 607 sensors for DO measurement are supplied as integrated components in SUB assemblies from leading single-use stirred-tank bioreactor manufacturers.
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  Humor Alert

  Fact Alert

How Much Water Should You Drink A Day? Hyponatremia

Over the last decade, there have been at least 15 cases of athletes who have died from over-hydration during sporting events. Too much fluid consumption can dilute the sodium in the blood, which creates a swelling of the brain and lungs.
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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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