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Aspen Alert

Issue # 3573 | November 3rd, 2021      

   News Alert

Pfizer Reveals Delays Across the Board for Its Clinical Gene Therapy Programs 

At JP Morgan 2020, a year after taking the reins at Pfizer, Albert Bourla claimed the company was poised to become a leader in gene therapy. He’s since thrown hundreds of millions of dollars at those plans, including a $630 million deal just last month for two of Voyager’s AAVs. Now, it appears Phase III readouts are further away than Bourla had hoped. Setbacks have resulted in delays across all three of Pfizer’s clinical gene therapy programs, the company revealed in its Q3 results on Tuesday — including one trial which was paused over safety concerns.
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Yokogawa Acquires Insilico Biotechnology, Developer of Bioprocess Digital Twin Technology

Yokogawa has announced that it has acquired all shares of Insilico Biotechnology AG, a developer and provider of bioprocess software and services. Fostering the development of the bioeconomy is one of the priority issues within Yokogawa’s sustainability goals, and in line with that the company aims to leverage this acquisition to build total bioprocess solutions that support biopharmaceutical development through to manufacturing. Insilico’s digital twin technology uses an advanced hybrid model formed from a mechanistic model of the unique characteristics of an intracellular metabolic network and a data-driven model constructed from process data using the machine learning process. Terms of the deal have not been made public.
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CDC Advisers Endorse Pfizer’s Covid-19 Vaccine for Kids 5-11

Children aged 5 to 11 can begin to be vaccinated against Covid-19 within the next day or two after an expert panel advising the Centers for Disease Control and Prevention recommended that Pfizer’s pediatric vaccine should be used in this age group. The recommendation, which passed by a 14-0 vote, was approved a couple of hours later by CDC Director Rochelle Walensky. The Pfizer vaccine for children 5 to 11 years of age is the first pediatric Covid vaccine authorized for use in this country. The vaccine is one-third of the size of the adult vaccine doses; children will get two injections containing 10 micrograms of antigen given 21 days apart.
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   Quote Alert

   On This Day Alert

One World Trade Center Officially Opens in New York City, on the Site of the Twin Towers

On this day in 2014, One World Trade Center officially opens in Manhattan. The new tower, along with the rest of the World Trade Center complex, replaced the Twin Towers and surrounding complex, which were destroyed by terrorist attacks on September 11, 2001. The initial plans for the site were steeped in post-9/11 patriotic sentiment. Libeskind designed an asymmetrical tower that evoked the Statue of Liberty and stood at the same height as the original World Trade Center, topped with a spire rising to 1,776 feet. Pataki dubbed it the “Freedom Tower,” a name which became commonplace but had largely faded from use by the time One World Trade Center opened.
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  TED Alert

The Pharmacy of the Future? Personalized Pills, 3D Printed at Home

We need to change how we prescribe drugs, says physician Daniel Kraft: too often, medications are dosed incorrectly, cause toxic side effects or just don't work. In a talk and concept demo, Kraft shares his vision for a future of personalized medication, unveiling a prototype 3D printer that could design pills that adapt to our individual needs.
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  Poll Alert

Thinking ahead to your next vehicle purchase, is price the most important factor?

► Yes
► No

Previous Poll Results:

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  Bioprocess Alert

Gamma Irradiating Chromatography Columns Enables Bioburden-Free Integrated Continuous Biomanufacturing

An important consideration for integrated continuous biomanufacturing is that the downstream chromatography steps integrated with the bioreactor should maintain a low bioburden state throughout the entire duration of the operation. One potential strategy to achieve this is to start bioburden-free and functionally close the chromatography system. While chromatography skids themselves can be rendered bioburden-free, limitations exist in applying these methods to chromatography columns. The small column sizes used in continuous multicolumn chromatography enable gamma irradiation of disposable columns to render them bioburden-free. However, this approach has not been widely implemented, likely because gamma irradiation can negatively impact resin performance.
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Survey Alert

Is the spending of year-end money, the idea that you must spend the remainder of your budget before the close of the year or lose it, fact or fiction this year?

► Fact
► Fiction

Previous Survey Results:

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  Upstream Alert

Application of Metabolic Modeling for Targeted Optimization of High Seeding Density Processes

Process intensification by application of perfusion mode in pre-stage bioreactors and subsequent inoculation of cell cultures at high seeding densities (HSD) has the potential to meet the increasing requirements of future manufacturing demands. However, process development is currently restrained by a limited understanding of the cell's requirements under these process conditions. The goal of this study was to use extended metabolite analysis and metabolic modeling for targeted optimization of HSD cultivations. The metabolite analysis of HSD N-stage cultures revealed accumulation of inhibiting metabolites early in the process and flux balance analysis led to the assumption that reactive oxygen species (ROS) were contributing to the fast decrease in cell viability.
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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

Advanced Control Strategies for Bioprocess Chromatography: Challenges and Opportunities for Intensified Processes and Next Generation Products

Recent advances in process analytical technologies and modelling techniques present opportunities to improve industrial chromatography control strategies to enhance process robustness, increase productivity and move towards real-time release testing. This paper provides a critical overview of batch and continuous industrial chromatography control systems for therapeutic protein purification. The implementation of these control systems improves process capabilities to fulfil product quality criteria as processes are scaled, transferred and operated, thus fast tracking the delivery of new medicines to market.
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  Podcast Alert

The CHO Cell Line – From Reliable Workhorse to State-Of-The-Art Protein Powerhouse

In this podcast, Brandy Sargent at Cell Culture Dish speaks with Alan Dickson, Ph.D., Professor of Biology at the Manchester Institute of Biotechnology, University of Manchester about the evolution of the CHO Cell line from isolation to workhorse of the biomanufacturing industry, to gene edited knockout variants. It is an interesting look at why CHO cells have been so successful and how this success continues to be improved upon for manufacture of emerging therapeutics.
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  Fill/Finish Alert

Miniaturized Forced Degradation of Therapeutic Proteins and ADCs by Agitation-Induced Aggregation Using Orbital Shaking of Microplates

Microplate-based formulation screening is a powerful approach to identify stabilizing excipients for therapeutic proteins while reducing material requirements. However, this approach is sometimes not representative of studies conducted in relevant container closures. The present study aimed to identify critical parameters for a microplate-based orbital shaking method to screen biotherapeutic formulations by agitation-induced aggregation. For this purpose, an in-depth methodological study was conducted using different shakers, microplates, and plate seals. Aggregation was monitored by size exclusion chromatography, turbidity, and backgrounded membrane imaging.
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  Regulatory Alert

India Seeks Feedback on Creating Regulatory Framework that Supports Innovation

India has proposed regulatory reforms intended to encourage R&D and innovation in the biopharma and medtech industries. The proposals are part of a broader plan to make India a leader in drug discovery and innovative medical devices by establishing an entrepreneurial environment in the country. In working toward the goal, the Department of Pharmaceuticals (DoP) is proposing to simplify India’s regulatory processes to enable rapid drug discovery and innovation in medical devices. As DoP sees it, the Indian framework needs to expand beyond “the traditional regulatory objectives of safety and quality” by starting to “differentiate in favor of innovation.”
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  Discovery Alert

Study Casts Doubt on Theory That Women Aren't as Competitive as Men

As researchers investigate reasons for America's persistent gender wage gap, one possible explanation that has emerged in roughly the last decade is that women may be less competitive than men and are therefore passed over for higher-ranking roles with larger salaries. But a new study suggests that it's likely not that simple. Researchers found that women enter competitions at the same rate as men -- when they have the option to share their winnings with the losers. The study, conducted by the University of Arizona Center for the Philosophy of Freedom, and the University of San Francisco, is published in the journal Proceedings of the National Academy of Sciences.
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  Project Alert

WuXi Biologics Launches a New GMP Commercial Drug Product Facility

WuXi Biologics has successfully launched the GMP operation of its new drug product facility located in Wuxi, China, which is the eighth operational drug product facility in the global network of WuXi Biologics. The facility, called DP2, features a state-of-the-art isolator filling line for the continuous high-speed production of wide size range – from 2R to 50R of liquid and 20m2/40m2 of lyophilization. Leveraging its innovative design, the facility can switch rapidly between different specifications to maximize its filling efficiency, providing flexible drug product manufacturing solutions to meet customers' needs. DP2 will increase up to 60 million vials for commercial drug production of biologics per year.
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  Patent Alert

Charged Depth Filtration of Antigen-Binding Proteins

A U.S. Patent for "Charged Depth Filtration of Antigen-Binding Proteins" was awarded to Amgen on August 24, 2021. The present invention involves methods of producing an aqueous formulation of an antigen-binding protein or enhancing re-oxidation of an antigen-binding protein are disclosed. The methods comprise (a) contacting an aqueous solution comprising antigen-binding protein molecules with a charged depth filter under conditions sufficient to enhance re-oxidation of the antigen-binding protein molecules and achieve a decrease in the percentage of reduced antigen-binding protein molecules, compared to the percentage of reduced antigen-binding protein molecules observed prior to step (a); and (b) optionally, measuring the amount or relative amount of reduced antigen-binding protein molecules.
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  Solution Alert

Purification of Recombinant Proteins on Nuvia cPrime Hydrophobic Cation Exchange Media: A Simple Approach to Method Development

Here, we describe the use of a Design of Experiment (DOE) approach in the initial screening of chromatographic conditions for the purification of a diverse set of protein targets on Nuvia cPrime hydrophobic cation exchange media. The ligand on this media has three major functionalities: a weak carboxylic acid end group, an aromatic hydrophobic ring, and an amide bond serving as a potential hydrogen bond donor/acceptor. The combined effect of these structural elements provides unique selectivity and good conductivity tolerance, allowing protein purifications to be conducted effectively under gentle conditions.
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  Humor Alert

  Fact Alert

One World Trade Center – An Architectural and Emotional Force

One World Trade (formerly known as the Freedom Tower) has become an architectural and emotional force in Lower Manhattan. Taking heed of every structural and safety failure of the Twin Towers, developers carefully designed the new tower to be the safest office building in the world.
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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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