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Aspen Alert

Issue # 3599 | December 9th, 2021      

   News Alert

Biogen Considering Massive Layoffs in Wake of Disappointing Aduhelm Rollout

According to a report by STAT, massive layoffs could be headed to Biogen due to the disappointing rollout of its Alzheimer's drug Aduhelm. The company could lay off as many as 1,000 employees as it continues to deal with the controversial treatment. The process is still being ironed out by the company's leadership and board of directors, but the axe could fall before the end of the holiday season, leaving many people looking for a new job in 2022. Additionally, some of the blame for Aduhelm's failure is being placed on the company's head of R&D, Alfred Sandrock. Citing conversations "with people close to the situation," STAT says Sandrock is being forced to shoulder the blame for the controversial approval of Aduhelm, as well as its less than impressive commercial launch.
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FDA Advisers Unanimously Agree Reata's Kidney Drug is Not Effective at Slowing Disease Progression

A panel of FDA advisers has voted unanimously, 13 to 0, that Reata Pharmaceuticals' chronic kidney disease (CKD) med was not effective. The committee said bardoxolone did not prove effective in slowing the progression of CKD in patients with Alport syndrome and that its benefits did not outweigh its risks based on data Reata submitted. The FDA is slated to decide the drug's fate Feb. 25, 2022. If given the green light, Reata's drug would be the first approved treatment for Alport syndrome. While bardoxolone achieved its primary and key secondary goals in a phase 3 trial, dubbed CARDINAL, the agency's review team questioned whether the drug actually reduced disease progression.
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Pfizer, Ex-Employee Reach a Deal in COVID-19 Vaccine Trade Secrets Case

A now-former Pfizer employee is playing nice after the drugmaker sued her in November alleging the 15-year veteran uploaded more than 12,000 sensitive files—including documents on the company's wildly successful COVID-19 vaccine—to personal devices and a Google Drive account. The defendant, Chun Xiao Li, agreed to let Pfizer's lawyers search her personal emails, Google drive accounts and all other personal computing devices or accounts that could contain confidential information or trade secrets by Dec. 6, court documents filed this week show. Pfizer aims to complete its search by Dec. 29, at which point it will return Li's devices and accounts.
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   Quote Alert

   On This Day Alert

1965 - "A Charlie Brown Christmas", the First Peanuts Animated Special Premieres  

More than 50 years since its premiere on CBS on December 9, 1965, A Charlie Brown Christmas remains one of the most beloved holiday specials of all time. Like Charlie Brown himself, the flaws—scratchy voice recordings, rushed animation—have proven endearing.
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  TED Alert

Why Do We Kiss Under Mistletoe?

The sight of mistletoe may either send you scurrying or, if you have your eye on someone, awaiting an opportunity beneath its snow-white berries. But how did the festive tradition of kissing under mistletoe come about? Carlos Reif explains how this long-lived custom intertwines the mythology and biology of this intriguing plant.
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  Poll Alert

Do you think the U.S. should give money to poorer countries to help them move to cleaner energy sources?

► Yes
► No

Previous Poll Results:

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  Bioprocess Alert

Intensified DoE Can Help Biopharma Cut Process Development Costs

To ensure a biomanufacturing process is consistent and efficient, scientists use a statistical analysis technique called design-of-experiment (DoE) to understand the relationship between the materials (inputs) and varied parameters tested in separate production runs. But while the approach is effective, it is time consuming according to a Boehringer Ingelheim analytical development scientist, Verena Nold, PhD, who says intensified DoE (iDoE) may be a better fit for drug companies that want to do more in less time, more efficiently.
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Survey Alert

How concerned are you about the Omicron variant of COVID-19? Please comment on your reason(s).

► Very Concerned
► Somewhat Concerned
► Not Concerned

Previous Survey Results:

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  Upstream Alert

Implementation of QbD Strategies in the Inoculum Expansion of a mAb Production Process

The quality by design approach was introduced to the biopharmaceutical industry over 15 years ago. This principle is widely implemented in the characterization of monoclonal antibody production processes. Anyway, the early process phase, namely the inoculum expansion, was not yet investigated and characterized for most processes. In order to increase the understanding of early process parameter interactions and their influence on the later production process, a risk assessment followed by a design of experiments approach was conducted. It was found that the passage duration as well as the initial viable cell density for each passage during the inoculum expansion have severe effects on the growth rate and viability of the early process phase.
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Event Alert

Current Technological Trends and Advancements in Vector Purification

Wednesday, December 15th, 2021

Ashish Saksule, Cell and Gene Therapy Process Development Lead, Takeda

Demand for adeno-associated viral (AAV) vector-driven gene therapy space continues to grow, as the sector migrates into indications with larger patient population and dosage requirements. It is imperative that downstream processing doesn’t apply a handbrake to recent gains made in increasing upstream process scale and titer.
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 Downstream Alert

Process Analytical Technology in Continuous Processing: Model-based Real Time Control of pH Between Capture Chromatography and Viral Inactivation for Monoclonal Antibody Production

A real time mechanistic model-based control strategy is demonstrated for in-line pH adjustment post-capture chromatography and prior to viral inactivation for continuous processing of monoclonal antibodies. At this point in the process, tight control of pH is essential, as pH fluctuations above 3.5 can result in incomplete viral inactivation, while fluctuations below 3.5 can lead to significant aggregate formation. The present approach predicts the pH profile during the transition phase between chromatography wash and elution steps by modelling the process stream at the column outlet as a mixture of two independent buffer systems. Control of pH in this transition phase is a critical consideration in capture chromatography as a significant amount of mAb material is eluted at this time.
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  Podcast Alert

The Twisted History of Dentistry

If you think going to the dentist now is not fun, just wait until you hear about what they did in the Middle Ages.
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  Fill/Finish Alert

Critical Considerations in the Formulation Development of Parenteral Biologic Drugs

Biopharmaceuticals, unlike chemically synthesized small-molecule drugs, are marginally stable, with most of them requiring 3D structures to retain their activity and/or potency. This implies challenges to formulate these molecules for a shelf life >2 yrs and also to minimize the cost of goods for manufacturing. Patient compliance has become a key consideration in the design and development of suitable dosage forms in the modernized world. Thus, here we describe different classes of biological therapeutics, with an emphasis on molecular properties, formulation challenges, and development strategies. We also present statistics on the different classes of approved biologic drugs and dosage forms.
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  Regulatory Alert

FDA Rolls Out More Guidance on 'N of 1' Gene Therapies

Developers of individualized investigational antisense oligonucleotide (ASO) therapies for ultra-rare diseases received additional guidance from the US FDA. In two draft documents, the agency has provided new information for sponsor-investigators and for those overseeing manufacture of these so-called “N of 1” therapies for people with severely debilitating or life-threatening genetic disease. The newly released draft guidance’s complement a January 2021 draft guidance covering administrative and procedural considerations for ASO developers and an April document that focuses on nonclinical testing of the therapies.
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  Discovery Alert

The Impact of Drugs on Gut Microbes is Greater Than We Thought

We are one of the most medicated generations of humans to live on our planet. Cardiometabolic diseases like type 2 diabetes, obesity, and coronary artery disease continue to increase in prevalence and together constitute the highest cause of mortality worldwide. Affected people often have to take multiple daily medications for months or even years. Researchers from the Bork group at EMBL Heidelberg, working together with a European consortium involving more than twenty European institutes, have now shown that many commonly used drugs have powerful effects on our gut microbes. These include drugs used to treat cardiometabolic disorders and antibiotics. The results were published in the journal Nature.
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  Project Alert

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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  Patent Alert

Method for Virtually Configuring a Piece of Equipment, Computer Program Product and Corresponding Augmented Reality System

A U.S. Patent for a "Method for Virtually Configuring a Piece of Equipment, Computer Program Product and Corresponding Augmented Reality System" was awarded to Sartorius on September 21st, 2021. The present invention is a method for virtually configuring a piece of equipment comprises providing an augmented reality system having a computer unit and at least one sensor unit, detecting a sensor dataset associated with a physical environment by means of the at least one sensor unit, determining a virtual environment based on the sensor dataset by means of the computer unit, and determining a virtual arrangement of at least one virtual and/or physical equipment element relative to the virtual environment.
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  Solution Alert

Selecting the Best Biomass Monitoring Technology for Your Application

Biomass concentration is defined as the concentration of microbial cells in a culture at a given point in time. Biomass monitoring follows the development of the cell concentration over time and characterizes the growth of the cultivated microorganism. To describe the development of biomass over time, various parameters (such as backscatter, absorbance, turbidity, optical density (OD), cell dry weight, or cell count) but also synonyms for biomass (like cell density and total cell density or TCD) are used. No matter what it’s called, biomass is one of the most important critical process parameters (CPPs) in microbial upstream bioprocessing.
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  Humor Alert

  Fact Alert

Cherry Trees Were Once Used as Christmas Trees 

These days, the most popular Christmas trees are Scotch pine, Douglas fir, Fraser fir, balsam fir, and white pine. However, in the early days before everyone settled on firs and pines, some Europeans used cherry or hawthorn trees as their Christmas greenery, according to Sandborn. The appeal of these trees was in their flowers. If you cut off a branch, brought it inside, and set it in a pot of water, it would flower just in time for Christmas.
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   Career Alert

Siemens
Validation/Quality Lead
Harleysville, PA
The Validation Quality Lead will be responsible for driving our pharmaceutical applications based on our process control system SIMATIC PCS 7 and PCS neo in addition to our Manufacturing Execution System Opcenter Execution Pharma by optimally adapting our systems to the customer’s validation strategy. Learn More

Bio-Rad
Senior Product Manager – Chromatography
Hercules, CA
We are looking for a highly motivated Senior Product Manager to join our team in the Protein Purification Business at Bio-Rad Laboratories.  We work with scientific researchers to develop new products, internally manage the development of those products, create go-to market strategies to commercialize products, and implement global business strategies. Learn More

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

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