Copy
Newsletter/Marketing

Having trouble viewing this email? Click here

Aspen Alert

Issue # 3581 | November 15th, 2021      

   News Alert

BioPharma Giant Johnson & Johnson Will Split Into 2 Companies

Johnson & Johnson, the New Jersey-based biopharmaceutical giant, will separate into two publicly traded companies, creating an entirely new, rebranded consumer health business, the company has announced. It’s a major change for the 135-year-old institution. The split will see J&J separate its consumer products arm — responsible for Band-Aids, Tylenol, Listerine and Neutrogena — from its biopharmaceutical and medical device branches within 18 to 24 months, the company said. The decision was first reported by The Wall Street Journal. The company’s pharmaceutical and medical device divisions will operate under the Johnson & Johnson brand. It’s unclear what the new consumer health company will be named.
Learn More

Biden Nominates Califf as FDA Commissioner

After months of speculation – and just days before a statutory deadline – President Joe Biden has announced he would nominate Robert Califf to serve as Commissioner of the FDA for the second time. The long path Biden took to nominating a permanent commissioner to helm the FDA struck many as a curious move at a time when the agency has had a highly visible role at the forefront of the nation's public health response to the COVID-19 pandemic. However, many observers' concerns were allayed by Biden's choice of veteran regulator Janet Woodcock to serve as acting commissioner. Woodcock first joined FDA in 1986 and has twice served as director of the Center for Drug Evaluation and Research (CDER), most recently from 2007 to 2020, before stepping away from that role to assist on Operation Warp Speed.
Learn More

Merck's COVID-19 Antiviral Pill vs. Pfizer's: What's the Same, What's Different

Both Merck and Pfizer have recently released data suggesting their COVID-19 antiviral pills are safe and effective ways to treat COVID-19, and if approved, both could be game changers in the fight against the virus. Merck's antiviral is called molnupiravir. The drugmaker has already filed for emergency use authorization of the drug, saying it cuts the risk of hospitalization or death from COVID-19 by about 50 percent. The FDA's advisory committee is set to meet Nov. 30 to discuss authorizing the drug. Pfizer's antiviral is called Paxlovid, and the drugmaker said it cuts the risk of hospitalization or death by 89 percent. The company plans to file for emergency use authorization from the FDA as soon as possible.
Learn More

ADVERTISEMENT

   Quote Alert

   On This Day Alert

1904 King C. Gillette Patents the Gillette Razor Blade

On this day in 1904, Boston-based inventor King Camp Gillette received a patent for an improved safety razor with a disposable blade. After almost 10 years of work, Gillette succeeded in mass-producing a sharp blade stamped from inexpensive sheet steel. He realized that profits lay in selling the razor for less than it cost to make and the disposable blades for more. His revolutionary idea has come to be known as the "Razor and Blades," or "loss leader," business model. Gillette was a marketing genius as well as a clever inventor. He introduced the practice of having professional athletes endorse a product and made sure that every American soldier went off to the First World War and returned home with a Gillette safety razor set.
Learn More

ADVERTISEMENT

  TED Alert

Why Do We Have Hair In Such Random Places?

Discover how humans lost their fur as they evolved from primates, and why we still have hair on our bodies.
Learn More

  Poll Alert

If you had to choose one of the following unpleasant options, which would you prefer?

► I’d rather be too hot
► I’d rather be too cold

Previous Poll Results:

ADVERTISEMENT

Learn More

  Bioprocess Alert

An Automated Sampling System for Online Monitoring as a Process Analytical Technology (PAT) Tool

This application note demonstrates the use of the Agilent 1290 Infinity II 2D‐LC system in combination with the Flownamics Seg‐Flow system for automated bioreactor sampling as a UHPLC‐based process analytical technology (PAT) tool for upstream titer and product quality assessments of mAbs and fusion proteins. This combination enables the determination of multiple upstream critical quality attributes (CQAs) using a single setup and saves time and costs during the development of biotherapeutics. 2D‐LC heart‐cutting combined with a flow split after the first dimension enables shorter run time, improved peak shape, and therefore faster results to control the process.
Learn More

View More

Survey Alert

When do you anticipate a return to “normal” for our industry? “Normal” defined as being like it was prior to the challenges of the past 18+ months. Please comment on your reason(s).

► Now
► 3-6 Months
► 6-12 Months
► 12-24 Months
► Never

Previous Survey Results:

ADVERTISEMENT

Learn More

  Upstream Alert

Innovative Approaches for Selecting and Optimizing Versatile Chemically Defined Media

At the 2021 Multi-Functional Cell Therapies (MFCT) Summit, Robert Newman, PhD, CSO, FUJIFILM Irvine Scientific, presented innovative approaches that his R&D team uses to select and optimize versatile, chemically defined media, as well as how these efforts drive the successful development and production of combination biotherapies.
Learn More

View More

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.
Learn More

ADVERTISEMENT

Learn More

 Downstream Alert

Complex Pump-Driven Blending in a Bioprocess Application

There are quite a few applications that require multiple streams to converge into a single process flow. Two such examples are buffer formulation and liquid chromatography gradient elution. In bioprocess applications, the required feeds are not typically pressurized, making it necessary to have a dedicated pump for each. A multi-head diaphragm pump is the optimal choice for low flow pulsation and high repeatability – these pumps must pull suction when primed in order to steadily drive process fluid from a bag or carboy into the system. Then again, WFI or PW utilities may reach the system at a much higher pressure than other process inlets. If this occurs, a sanitary liquid regulator can be used to balance the water inlet with all other contributing feeds.
Learn More

View More

  Podcast Alert

Programming Cell Therapies to Overcome Solid Tumor Defense Systems

While CAR-T cell therapies have emerged as promising anti-cancer agents, their success have been focused on hematologic cancers. ArsenalBio is working to develop more robust cell therapies capable to treating a broader range of cancers by using synthetic biology to make them programable. We spoke to Ken Drazen, CEO of ArsenalBio, about the company’s next-generation T cell therapies, how it is able to program functions into these cells to overcome solid tumor defenses, and the company’s collaboration with Bristol-Myers Squibb announced at the start of the year.
Learn More

ADVERTISEMENT

Learn More

  Fill/Finish Alert

How Single Use Systems Could Revolutionize Fill Finish Changeover

When it comes to assuring product sterility, you can’t take shortcuts – or can you? Single-use systems could be the key to speeding up change-over of fill finish production lines without compromising sterility. After a series of complex processes, parenteral fill finish is the final manufacturing stage of sterile dosage drugs. Since they are administered intravenously there are critical safety requirements and risks, and to ensure the product is sterile global regulatory authorities have stringent guidelines on the implementation of robust operational and quality systems. In the case of aseptic drug products this is particularly crucial because we cannot test the sterility of the finished product.
Learn More

  Regulatory Alert

Biden Nominates Califf as FDA Commissioner

After months of speculation – and just days before a statutory deadline – President Joe Biden has announced he would nominate Robert Califf to serve as Commissioner of Food and Drugs for the second time. Califf, who previously headed the US FDA from February 2016 to January 2017, is a renowned clinical trialist and a founding director of the Duke Clinical Research Institute. Since leaving the FDA in 2017, Califf has served as a senior adviser to Alphabet's life sciences arm Verily and has continued teaching, research and clinical duties at Duke University School of Medicine. The long path Biden took to nominating a permanent commissioner to helm the FDA struck many as a curious move at a time when the agency has had a highly visible role at the forefront of the nation's public health response to the COVID-19 pandemic.
Learn More

ADVERTISEMENT

Learn More

  Discovery Alert

Anxiety Cues Found in the Brain Despite Safe Environment

Imagine you are in a meadow picking flowers. You know that some flowers are safe, while others have a bee inside that will sting you. How would you react to this environment and, more importantly, how would your brain react? This is the scene in a virtual-reality environment used by researchers to understand the impact anxiety has on the brain and how brain regions interact with one another to shape behavior. "These findings tell us that anxiety disorders might be more than a lack of awareness of the environment or ignorance of safety, but rather that individuals suffering from an anxiety disorder cannot control their feelings and behavior even if they wanted to," said Benjamin Suarez-Jimenez, Ph.D., assistant professor in the Del Monte Institute for Neuroscience at the University of Rochester and first author of the study published in Communications Biology.
Learn More

  Project Alert

$165 Million Biopharmaceutical Center ‘A Big Game Changer’ for University of Delaware

When the Ammon Pinizzotto Biopharmaceutical Innovation Center opened at the University of Delaware’s STAR Campus in late February 2020, officials were excited to begin using the glimmering, $165 million facility meant to foster collaboration between different disciplines of science. Less than a month later, the pandemic dashed those plans, delaying the full occupancy of the building and postponing any public celebration of its completion. Recently, UD officials finally got to celebrate the opening of the building, holding a ribbon-cutting ceremony and donor recognition event. The six-story, 228,000-square-foot Ammon Pinizzotto Biopharmaceutical Innovation Center – called A.P. Bio for short – houses NIIMBL, the Delaware Biotechnology Institute, the Department of Biomedical Engineering and Biopharmaceutical Sciences.
Learn More

ADVERTISEMENT

Learn More

  Patent Alert

Linked Perfusion to Continuous-Flow Stirred Tank Reactor Cell Culture System

A U.S. Patent for "Linked Perfusion to Continuous-Flow Stirred Tank Reactor Cell Culture System" was awarded to Boehringer Ingelheim on August 31, 2021. The present invention addresses methods of protein production in a linked culture and production bioreactor system are provided. Such methods include a culture bioreactor (N-1 bioreactor) linked to production bioreactor (N bioreactor). More specifically, the methods include (a) culturing cells with a gene that encodes the protein of interest in a continuous perfusion culture bioreactor (N-1 bioreactor); inoculating a continuously stirred tank reactor (CSTR) production bioreactor (N bioreactor) with cells obtained from step (a); and culturing the cells in the CSTR production bioreactor under conditions that allow production of the protein of interest.
Learn More

  Solution Alert

Single Use Valve for Biopharmaceutical Applications

The Equilibar® back pressure regulator and flow control valve is now available in a sanitary single use design to accommodate the rapidly expanding single use technology (SUT) field in the biopharmaceutical industry. Single use systems (SUS) require lower cost components that can be sterilized through irradiation and disposed of after use. The patent pending Equilibar® SD series is manufactured using USP Class VI polymers and stainless steel. The polymer body and diaphragms are disposable and are inserted into a stainless-steel support housing with wing nut closure for quick and easy assembly.
Learn More

View More

ADVERTISEMENT

Learn More

  Humor Alert

  Fact Alert

Men Have Been Shaving For 5,000 Years

Man first learned to shave using raw materials like flint, shark teeth, and clam shells. These tools appeared in drawings found in prehistoric caves. The very first razors were made from copper and solid gold – as discovered in Egyptian tombs that date back to the 4th millennium B.C. It was a custom in ancient Egypt (for men and women) – to shave their heads and facial hair.
Learn More

ADVERTISEMENT

Learn More
Subscribe

ADVERTISEMENT

ADVERTISEMENT

ADVERTISEMENT

ADVERTISEMENT

ADVERTISEMENT

ADVERTISEMENT

ADVERTISEMENT

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

   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

Aspen Media, Inc.
Contact

My Account
Login
Custom Notifications
Favorites

Aspen Alert
Past Issues
Subscribe

Aspen Atheneum
Archive

Aspen Marketplace
Aspen Events Calendar
Aspen Career Center

Contribute

Aspen Atheneum
Aspen Events Calendar
Aspen Career Center
Aspen Surveys

Privacy Center
Privacy Policy
Terms of Use
Do Not Sell My Personal Info

Follow Us On Social Media!

 POWERED BY ASPEN MEDIA, INC. © COPYRIGHT 2021







This email was sent to <<Email Address>>
why did I get this?    unsubscribe from this list    update subscription preferences
Aspen Media, Inc. · 1776 Park Avenue, Suite 4223 · Park City, UT 84060 · USA