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Aspen Alert

Issue # 3336 | November 24th, 2020      

   News Alert

RESILIENCE Launches to Change the Future of Medicine through Manufacturing Innovation

RESILIENCE, founded by ARCH Venture Partners' Robert Nelsen, formally launched this week. The first-of-its-kind biopharmaceutical manufacturing and technology company, which has raised over $800 million in capital, will invest heavily in developing powerful new manufacturing technologies across multiple therapeutic modalities, including cell and gene therapies, viral vectors, vaccines, and proteins. According to the announcement the company will be led by a highly accomplished team of biopharma industry executives and advisors, many of whom household names in our community.
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Cyber Attacks on BioPharma Industry Escalate 

Attacks on the biotech and pharmaceutical industry increased by 50% between 2019 and 2020, according to a BlueVoyant report. The report highlighted that nation-states are ramping up cyber-attacks on companies that are developing vaccines, and this is likely to increase as production and distribution gets underway. The analysis examined open-source records of 25 publicly reported attacks that have taken place in the last four years. It set out to define key risks and how COVID-19 has changed the threat landscape. Establishing that ransomware is still the number one threat vector for this industry, the report identifies the key risks that companies face and the steps they need to take to mitigate these.
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Merck to Acquire OncoImmune for $425 Million in Cash

Merck will acquire clinical-stage biopharmaceutical company OncoImmune for $425 million, per a definitive agreement announced this week. This comes just two months after OncoImmune’s COVID-19 therapeutic candidate CD24Fc demonstrated efficacy during an interim analysis of Phase III data. Prior to the completion of the acquisition, OncoImmune will spin-out certain rights and assets unrelated to the CD24Fc program to a new entity to be owned by the existing shareholders of OncoImmune; and Merck will invest $50 million and become a minority shareholder in the new entity. The closing of the acquisition is expected before the end of 2020.
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   Quote Alert

   On This Day Alert

"Origin of Species" is Published 

On the Origin of Species by Means of Natural Selection, a groundbreaking scientific work by British naturalist Charles Darwin, is published in England. Darwin’s theory argued that organisms gradually evolve through a process he called “natural selection.”
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  TED Alert

Before I die I want to … 

In her New Orleans neighborhood, artist and TED Fellow Candy Chang turned an abandoned house into a giant chalkboard asking a fill-in-the-blank question: "Before I die I want to ___." Her neighbors' answers -- surprising, poignant, funny -- became an unexpected mirror for the community. (What's your answer?)
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  Poll Alert

Do you personally know anyone who has experienced domestic violence? 

► Yes
► No

Previous Poll Results:

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  Bioprocess Alert

Story of the Steritest™ Invention: How Millipore Made the Sterility Test Reliable in the 1970s

Fernand Burghard, Millipore’s European Manufacturing Director until 2000, was part of the Steritest™ adventure from the beginning. In an interview, he tells us about how this breakthrough sterility testing system came into being.
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Survey Alert

Do you expect single-use bioreactors to get larger or smaller? 

► Larger
► Smaller

Previous Survey Results:

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  Upstream Alert

Performance Comparison of CHO-S Cell Cultivation and mAb Production in the Allegro™ STR 200 Single-Use Bioreactor and in Conventional Single-Use Bioreactor

Today, the benefits of single-use (SU) technologies for upstream processing are much more prevalent and heavily adopted within biopharmaceutical industry. Pall has developed the Allegro™ STR stirred single-use bioreactor family which is currently available in 4 sizes: STR 50, STR 200, STR 1000, and STR 2000. The direct-bottom mechanically driven impeller allows large range of power inputs from 0.002 W/kg up to 0.3 W/kg, while the macro sparger seated below the three 45-degree elephant ear blades results in high oxygen transfer rates (kLa up to 40 h-1) and short mixing time (minimum tM~10 s).
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Event Alert

Meeting Challenging Market Demands: Can Traditional Column Chromatography Be Eliminated?

Thursday, December 3rd, 2020

Xindao Mao, Product Manager Chromatography Systems

Process intensification is one possibility to meet these goals. In the past, the focus of process intensification was mainly on the upstream side, which pushed the bottlenecks into the downstream area. An important step in DSP is mAb capture. Here the mAb is very specifically captured by a protein A ligand, resulting in >95% of purity. For several decades the default technology has been the use of packed bed column chromatography and diffusion-limited affinity resins. This is a significant pain point in the downstream process, as the flow rate limitations and subsequent underutilization of these resins present considerable investments and process risks for drug manufacturers. Rapid Cycling Chromatography (RCC) is one way to overcome the limitations of processes based on protein A resins.

In this exciting webinar, we will present how Sartorius addresses the needs for downstream process intensification with a newly developed Protein A membrane and an optimized RCC skid.
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 Downstream Alert

5 Case Studies Can Help You Improve Pharmaceutical Quality

This new case study collection highlights innovative weighing solutions that can help improve processes and product quality in pharmaceutical manufacturing, It shows how having a dependable and proficient partner that offers complete and innovative weighing solutions can help you achieve a higher level of productivity, compliance and safety than ever before. In this case study collection, you will find pharmaceutical weighing solutions and pharmaceutical best practices to help you.
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  Podcast Alert

When the Monkeys Met the Chimps 

Brian Cox and Robin Ince are joined by Dr Jane Goodall DBE, comedian Bill Bailey and primatologist Dr Cat Hobaiter to find out what we've learnt in the 60 years since Jane first discovered the chimpanzees of Gombe. From tool use, to language and even to culture, her revolutionary work has transformed our understanding of our great ape cousins, and ourselves. The panel chat about how far our understanding has come in that time, and talk about their own unique close-up experiences of chimpanzees, macaques and baboons, and Bill gets a masterclass in how to speak Chimp from a true expert!
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  Regulatory Alert

AstraZeneca to Seek FDA Authorization for Vaccine Based on Foreign Trial Data 

AstraZeneca says that it will submit preliminary data from large clinical trials in the U.K. and Brazil to the FDA as part of an application for emergency authorization. Data from those trials show the vaccine was about 70 percent effective across two different dosing regimens. When the vaccine was given as a half dose and then a full dose one month later to about 2,700 participants, it had an efficacy of 90 percent. When given as two full doses at least one month apart to about 8,900 participants, it showed 62 percent efficacy. The company says it will work with the FDA to adjust the design of its late-stage U.S. trial to test the half-dose regimen, rather than the higher dose that proved less effective in the U.S and Brazil studies.
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  Discovery Alert

Helicates Meet Rotaxanes to Create Promise for Future Disease Treatment 

A new approach to treating cancers and other diseases that uses a mechanically interlocked molecule as a 'magic bullet' has been designed by researchers at the University of Birmingham. Called rotaxanes, the molecules are tiny nanoscale structures that resemble a dumbbell with a ring trapped around the central post. This new design uses a much larger cylindrical-shaped supramolecular 'helicate' molecule -- around 2nm long and 1nm wide -- which have remarkable ability to bind Y-shaped junctions or forks in DNA and RNA. In laboratory tests, the Birmingham researchers have shown that, when they bind to the junctions, the cylinder molecules are able to stop cancer cells, bacteria and viruses from reproducing. The results are published in the Journal of the American Chemical Society.
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  Project Alert

Pharmactive Eyes Biotech Drug Manufacturing Facility in Turkey with South Korea's Polus 

Turkish pharmaceuticals manufacturer Pharmactivecplans to establish a biotechnological pharmaceutical factory in Turkey following the clinical trial results of five biotechnological drugs it is developing in partnership with South Korean firm Polus. Pharmactive Technical Operations General Manager Fatih Elay said in a report published by Turkish daily Dünya that the production process of five biotech drugs, which they developed jointly with Polus, was completed, and clinical trials were initiated. He said that if the results came back positive from those trials, they will make the factory investment in Turkey and build a factory that mirrors the one they currently have in Incheon.
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  Patent Alert

Process for Manufacturing Factor VIII Having an Improved Ratio of FVIII:C/FVIII/AG

A U.S. Patent for a "Process for Manufacturing Factor VIII Having an Improved Ratio of FVIII:C/FVIII/AG" was awarded to Octapharma on November 3rd, 2020. The present invention is a process for manufacturing of a Factor VIII product having a ratio of FVIII:C/FVIII:Ag of at least 0.7 in the Factor VIII product by using chromatography wherein at least one chromatographic step is performed by means of employing; An affinity chromatography resin having an affinity for specifically binding of Factor VIII which is effected by an affinity ligand which is immobilised on the affinity chromatography resin, said affinity ligand is a 13 kD yeast derived Fab antibody fragment directed to the Factor VIII molecule. An anionic chromatography resin. A size exclusion resin...
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  Solution Alert

Fermentation

Development of Redox Potential-Driven Fermentation Process for Recombinant Protein Expression
 
A redox potential-driven fermentation, maintaining dissolved oxygen at a prescribed level while simultaneously monitoring the changes of fermentation redox potential, was developed to guide the cultivation progress of recombinant protein expression. A recombinant E. coli harboring prolinase-expressing plasmid (pKK-PepR2) was cultivated using the developed process. Two distinct ORP valleys were noticeable based on recorded profile. The first ORP valley is equivalent to the timing for the addition of inducing agent, and the second ORP valley serves to guide the timing for cell harvesting. The final prolinase activity is 0.172 μmol/mg/min as compared to that of 0.154 μmol/mg/min where the optical density was employed to guide the timing of inducer addition and an empirically determined length of the cultivation.
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  Fact Alert

Pumpkins Are 90% Water, Which Makes Them a Low-Calorie Food

One cup of canned pumpkin has less than 100 calories and only half a gram of fat. In comparison, the same serving size of sweet potato has triple the calories. They also have more fiber than kale, more potassium than bananas, and are full of heart-healthy magnesium and iron.
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   Career Alert

AdvantaPure/NewAge Industries
Manufacturing Director
Southampton, PA
Directs the thermoplastic, thermoset extrusion, molding and assembly manufacturing group in production and development. Provides new technologies to improve existing thermoset and thermoplastic extrusion, molding and assembly. Learn More

Kiniksa Pharmaceuticals
Senior Director, Upstream Process Dev & Mfg
Lexington, MA
This position will provide technical oversight and strategic guidance for all upstream development and manufacturing activities. Learn More

AbSci
LIMS Scientific Lead
Vancouver, WA
The LIMS Scientific Lead will lead and manage the implementation and maintenance of a LIMS system. Learn More

Spark Therapeutics
Technology Capital Projects Leader
Philadelphia Area, PA
This role is responsible for establishing and managing the overall project schedules from design through construction, commissioning, qualification and start-up. Learn More

Pfizer
Senior Associate Scientist Bioprocess R&D
Chapel Hill, NC
This person will provide science and technology expertise in the disciplines of macromolecule purification sciences for the development and optimization of vaccine manufacturing processes. Learn More

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