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Aspen Alert

Issue # 3579 | November 11th, 2021      

   News Alert

FDA Touts Success and Challenges in Biosimilar Development

A top official from the US FDA offered a mixed assessment of the agency’s biosimilars program, noting that although the program is growing, there is more uptake of the program in the oncology space, with less activity in other treatment areas. The costly and lengthy process of getting biosimilars approved is also a deterrent to wider uptake. Jacqueline Corrigan-Curay, principal deputy center director for FDA’s Center for Drug Evaluation and Research (CDER), made these observations in her update on the biosimilar development program in her CDER keynote address at this week’s meeting of the Association for Accessible Medicines’ (AAM) GRx+Biosim conference, which was held virtually this year.
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FibroGen Cuts Jobs as it Weighs Anemia Drug's Future in US

FibroGen is cutting jobs and restructuring as it struggles to get an anemia pill back on track in the U.S. after a major regulatory blow. The Food and Drug Administration rejected roxadustat in August, indicating Fibrogen needed more clinical study on the drug's safety. This week, FibroGen said it and partner AstraZeneca are scheduled to meet with the FDA soon to see if there's a viable path forward. The restructuring, meanwhile, will save FibroGen $100 million annually for the next three years. The company laid off about 30 employees in the U.S. and won't fill about 70 previously open positions. About 600 employees globally were employed by the company as of Jan. 31, 2021.
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Amgen Invests $365M in New Biomanufacturing Plant in Ohio

Amgen has broke ground for its newest biomanufacturing plant in New Albany, OH. The final product assembly and packaging plant will support production of medicines for the U.S. and is expected to be operational by 2024. Construction management for the project is being led by Turner Construction and design services are provided by CRB Group. "In building this site, we expect to invest $365 million," said Sam Guhan, vice president of Engineering at Amgen. The new site will be led by Sandra Rodriguez-Toledo, vice president of Site Operations at Amgen Ohio. "When operational, Amgen Ohio will be a state-of-the-art manufacturing facility, which will enable us to continue to bring new innovative medicines to every patient, every time," she said.
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   Quote Alert

   On This Day Alert

Dedication of the Tomb of the Unknown Soldier

Exactly three years after the end of World War I, the Tomb of the Unknown Soldier is dedicated at Arlington Cemetery in Virginia during an Armistice Day ceremony presided over by President Warren G. Harding.
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  TED Alert

Lessons We Can Learn From Veterans 

When we think of veterans, we often think of quasi-functional members of society who are in desperate need of our help. In this talk, Rajiv Chandrasekaran turns that single story on its head and shows how US veterans serve at the frontlines of service to communities around the world. His message is simple: Instead of focusing on how to help veterans, we should instead focus on how veterans can help us to be better people.
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  Poll Alert

Does anyone you communicate with use emojis in ways you don't understand?

► Yes
► No

Previous Poll Results:

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  Bioprocess Alert

Microbioreactor (Micro-Matrix) Potential in Aerobic and Anaerobic Conditions with Different Industrially Relevant Microbial Strains

Microscale fermentation systems are important high throughput tools in clone selection, and bioprocess set up and optimization, since they provide several parallel experiments in controlled conditions of pH, temperature, agitation, and gas flow rate. In this work we evaluated the performance of biotechnologically relevant strains with different respiratory requirements in the micro-Matrix microbioreactor. In particular Escherichia coli K4 requires well aerated fermentation conditions to improve its native production of chondroitin-like capsular polysaccharide, a biomedically attractive polymer. Results from batch and fed-batch experiments demonstrated high reproducibility with those obtained on 2 L reactors, although highlighting a pronounced volume loss for longer-term experiments.
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Survey Alert

Where in the mRNA manufacturing workflow do you see the most innovation likely to occur? Please comment on your reason(s).

► Upstream
► Downstream
► Fill/Finish
► Other

Previous Survey Results:

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  Upstream Alert

Study of a Single-Use Stirred Tank Bioreactor for Manufacturing a Therapeutic Protein in a High Cell Density Microbial Fermentation

Stirred tank single-use bioreactors (SUBs) have been widely adopted for production of biopharmaceuticals such as monoclonal antibodies in mammalian cell culture. However, they are seldom used for commercial production of biologics with microbial fermentation. SUBs offer time-saving advantages because they do not require significant downtime for cleaning and sterilization, so finding a SUB that can perform well with high cell density microbial fermentation processes has the potential to increase the number of production runs. Therefore, for this study, a Histagged protease inhibitor was chosen as a model protein to demonstrate that the Sartorius Biostat STR® MO, is suited for recombinant protein production by high cell density Escherichia coli fermentation processes.
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Event Alert

From Gene to Patient

Tuesday, November 16, 2021

At this one-day virtual event, experts and key opinion leaders in the areas of upstream processing, downstream processing, and analytics related to viral vectors and the gene therapy journey will share their insights. In addition to lectures, the event will provide a platform to facilitate networking and discussions with other experts in the field, including during meet-the-speaker sessions and coffee breaks. There is also the possibility for participants to register for a 1:1 meeting with a Sartorius expert.
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 Downstream Alert

Virus Recovery by Tangential Flow Filtration: A Model to Guide the Design of a Sample Concentration Process

A simple model is developed to describe the instantaneous (rv) and cumulative (Rv) recovery of viruses from water during sample concentration by tangential flow filtration in the regime of constant water recovery, r. A figure of merit, M = rvr, is proposed as an aggregate performance metric that captures both the efficiency of virus recovery and the speed of sample concentration. We derive an expression for virus concentration in the sample as a function of filtration time with the rate-normalized virus loss, =1−, as a parameter. The proposed model can guide the design of the sample concentration process and serve as a framework for quantification and interlaboratory comparison of experimental data on virus recovery.
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  Podcast Alert

Quantum Computing is Tomorrow's Computing, Today

Over the next decade, quantum computing has the potential to revolutionize the way we work and live. In this episode of Smart Talks, Malcolm talks to Dr. Darío Gil, Senior Vice President and Director of IBM Research, about quantum computing and its potential to accelerate discovery and development.
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  Fill/Finish Alert

In Situ Monitoring of Protein Unfolding/Structural States under Cold High-Pressure Stress

Biopharmaceutical formulations may be compromised by freezing, which has been attributed to protein conformational changes at a low temperature, and adsorption to ice–liquid interfaces. However, direct measurements of unfolding/conformational changes in sub-0 °C environments are limited because at ambient pressure, freezing of water can occur, which limits the applicability of otherwise commonly used analytical techniques without specifically tailored instrumentation. In this report, small-angle neutron scattering (SANS) and intrinsic fluorescence (FL) were used to provide in situ analysis of protein tertiary structure/folding at temperatures as low as −15 °C utilizing a high-pressure (HP) environment (up to 3 kbar) that prevents water from freezing.
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  Regulatory Alert

Industry Calls for Technical, Scope Changes in ICH S12 Guideline

In response to the US FDA’s consultation on the ICH S12 guideline on nonclinical biodistribution considerations for gene therapy products, two industry groups and drugmaker Novartis have suggested changes to the document. The guideline reached Step 2b of the ICH process in June and has been released for comment by regulators, including the EMA, to gather feedback before the international guideline can be adopted. The FDA issued the draft version of the document, which is intended to "facilitate the development of investigational [gene therapy] products, while avoiding unnecessary use of animals, in accordance with the 3Rs (reduce/refine/replace) principles, for public comment in September.
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  Discovery Alert

Anxiety Effectively Treated with Exercise

Both moderate and strenuous exercise alleviate symptoms of anxiety, even when the disorder is chronic, a study led by researchers at the University of Gothenburg shows. The study, now published in the Journal of Affective Disorders, is based on 286 patients with anxiety syndrome, recruited from primary care services in Gothenburg and the northern part of Halland County. Half of the patients had lived with anxiety for at least ten years. Their average age was 39 years, and 70 percent were women. Through drawing of lots, participants were assigned to group exercise sessions, either moderate or strenuous, for 12 weeks. The results show that their anxiety symptoms were significantly alleviated even when the anxiety was a chronic condition, compared with a control group who received advice on physical activity according to public health recommendations.
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  Project Alert

New ECU Life Sciences Building Officially Opening

East Carolina University’s new Life Sciences and Biotech Building is finally officially opening after the university had approved days added to the project as a result of weather, Covid and supply chain delays in materials. The $90-million 4-story building at the corner of East 10th Street and Evans Street has been under construction since 2019. It has over 141,000 square feet of space and will be the home for the ECU Department of Biology and ECU researchers. ECU says the original contract completion date was July 14, 2021. 79 days were added due to weather and 22 due to scope, carrying the project completion to Nov 22.
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  Patent Alert

Methods of Replicating a Large Scale Eculizumab Production Cell Culture

A U.S. Patent for "Methods of Replicating a Large Scale Eculizumab Production Cell Culture" was awarded to Alexion on August 31, 2021. The present invention is a method of replicating a large-scale eculizumab production cell culture in a small scale culture, the method comprising: providing a 4-L to 10-L fed batch bioreactor containing a first culture medium that occupies between about 70% and about 90% of the capacity of the bioreactor and has an initial cell density of between about 2.5.times.10.sup.5 and about 7.5.times.10.sup.5 NSO cells/mL, the cells comprising a nucleic acid encoding a recombinant eculizumab heavy chain comprising...
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  Solution Alert

5 Benefits of Using an MES for Pharma and Biotech

Manufacturing Execution Systems (MES) replace paper-based, slow and error-prone processes in the manufacture of pharmaceutical and biopharmaceutical products. But what exactly are the benefits of digitization for pharma and biotech manufacturers? And how do you find the right MES supplier.
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  Humor Alert

  Fact Alert

Veterans Day Facts

Veterans Day occurs on November 11 every year in the United States in honor of the “eleventh hour of the eleventh day of the eleventh month" of 1918 that signaled the end of World War I, known as Armistice Day. Veterans Day originated as “Armistice Day” on November 11, 1919, the first anniversary of the end of World War I. Congress passed a resolution in 1926 for an annual observance, and November 11 became a national holiday beginning in 1938.
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   Career Alert

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

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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