Bayer Buying AskBio for $2 Billion in Cash

                                                                                          Issue # 3316 | October 27th, 2020     




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News Alert


Bayer Buying AskBio for $2 Billion in Cash

Bayer has agreed to acquire Asklepios Biopharmaceuticals, a privately held gene therapy developer formed nearly two decades ago by one of the field's pioneers, University of North Carolina researcher Jude Samulski. The German healthcare conglomerate will pay $2 billion in cash for AskBio, which has several programs in preclinical and early development as well as its own contract gene therapy manufacturing business. The deal's value could as much as double if AskBio's research hits certain development milestones. The buyout should help establish Bayer as an emerging player in the cell and gene therapy field, something it's sought to accomplish through dealmaking. Learn More




Vaccine Makers Can Skip Site Inspections by U.S. FDA
 
The U.S. FDA inspects a few thousand drug manufacturing plants every year to ensure their standards are up to par. Many of those inspections are required before a biopharma company can gain approval of a new drug. They serve as a check on whether drugmakers can produce quality therapies. But that won't be the case for Covid-19 vaccine developers that gain emergency authorization of a shot. FDA regulations don't require what's known as a pre-approval inspection for products seeking emergency use, said Jerry Weir, director of the Division of Viral Products in the FDA's vaccines office. Weir spoke last week at a meeting of FDA advisers to discuss standards for Covid-19 vaccines. Learn More
 


FDA Delays Decision on Spectrum Pharma's Drug Candidate Due to Travel Curbs

The US FDA has deferred a decision on Spectrum Pharmaceuticals' SPPI.O drug candidate to treat chemotherapy induced loss of white blood cells in cancer patients due to COVID-19 related travel curbs. This comes after the regulatory agency was unable to inspect the company's South Korea-based manufacturing plant, a step required before the approval of the drug, the company said. The regulator had warned in April it may not be able to sustain its current level of timely reviews and approvals of marketing applications as many of its staff were allocated to the coronavirus crisis. Learn More

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Quote Alert


On this Day Alert

2006 Chick-fil-A Founder Takes Last Ford Taurus



On this day in 2006,  the last Ford Taurus rolls off the assembly line in Hapeville, Georgia. The keys to the silver car went to 85-year-old Truett Cathy, the founder of the Chick-fil-A fast-food franchise, who took it straight to his company's headquarters in Atlanta and added it to an elaborate display that included 19 other cars, including one of the earliest Fords. Learn More

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TED Alert

How Understanding Divorce Can Help Your Marriage


To understand what makes marriages work, we need to talk about why they sometimes end, says family law professor Jeannie Suk Gersen. Follow along as she lays out three ways that thinking about marital decisions through the lens of divorce can help you better navigate togetherness from the beginning. Learn More

Poll Alert

Do you approve or disapprove of Pope Francis saying, "Homosexuals have a right to be a part of the family. They are children of God and have a right to a family"?

Approve
Disapprove


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Bioprocess Alert

Bioprocess Intensification: Aspirations and Achievements
 

   
There are many drivers to intensify the manufacturing of a biological product. Advances are occurring throughout the biomanufacturing arena, from process development techniques to improved manufacturing platforms, equipment and facilities. Many employ the term 'bioprocess intensification' to refer to systems for producing more product per cell, time, volume, footprint or cost. This need is being driven by two emerging priorities: cost control and process efficiency. We are seeing great interest in the power of such disciplines as synthetic biology, process simplification, continuous bioprocessing and digital techniques in the optimization of bioprocess development and manufacturing. Other powerful disciplines here include process automation, improved monitoring and prefabricated facility modularity and podularity. Learn More

Survey Alert


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Upstream Alert

Adaptation of Mammalian Cell Lines to Serum-Free Culture Media



Traditional mammalian cell culture is usually anchor-dependent and serum-supplemented. Animal-derived components tend to introduce lot-to-lot variability and blood-borne pathogens. Use of serum also tends to increase immunogenicity and production costs. Because of these issues, suspension cultures in animal-derived component free (ADCF) cell culture media are usually preferred for situations like recombinant protein production or viral vector/virus production due to its suitability to industrial processing and scale up. However, transitioning from adherent to suspension serum-free culture has its own set of challenges and is time consuming. Learn More

Event Alert


Webinar: Stem Cell Derived Exosome Production in Stirred-Tank Bioreactors

Thursday, November 5th, 2020

Speakers: Jorge Escober, Senior Research Scientist and Aurelie Tacheny, Project Manager and Application Specialist at Eppendorf

Exosomes are a population of naturally occurring mobile, membrane-limited, 30 - 100 nm in diameter, extracellular vesicles containing a large number of proteins, lipids, messenger, and micro-RNAs. Stirred-tank bioreactors offer the possibility to tightly control and monitor the production of exosomes, as well as the scalability, to produce increasing amounts. However, the cultivation of stem cells in stirred-tank bioreactors requires profound knowledge and precise control of the process. In our talk, we will highlight the potential and benefits of stirred-tank bioreactors in the cultivation of stem cells for exosome production.


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Downstream Alert

Tangential Flow Filtration to Concentrate Aqueous Environmental Samples


In this video, Dr. Timothy Martin & Dr. Russell Davenport of Newcastle University demonstrate tangential flow filtration to concentrate aqueous environmental samples. Included in this demonstration is an overview of the concentration process, procedures for cleaning and maintenance and an example concentration. Learn More

Podcast Alert
 
Hard Hits


When a race car hits the wall at 200 mph, how much force is involved? How much energy is behind a punch to the face? On this episode of StarTalk Sports Edition, Neil deGrasse Tyson and co-hosts Chuck Nice and Gary O'Reilly are investigating the physics of all the hard hits you love in sports. Learn More

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Regulatory Alert

FDA Delays Decision on Spectrum Pharma's Drug Candidate Due to Travel Curbs

 
The US FDA has deferred a decision on Spectrum Pharmaceuticals' SPPI.O drug candidate to treat chemotherapy induced loss of white blood cells in cancer patients due to COVID-19 related travel curbs. This comes after the regulatory agency was unable to inspect the company's South Korea-based manufacturing plant, a step required before the approval of the drug, the company said. The regulator had warned in April it may not be able to sustain its current level of timely reviews and approvals of marketing applications as many of its staff were allocated to the coronavirus crisis. Learn More

Discovery Alert

DrugCell: New Experimental AI Platform Matches Tumor to Best Drug Combo


 
Only 4 percent of all cancer therapeutic drugs under development earn final approval by the U.S. FDA. "That's because right now we can't match the right combination of drugs to the right patients in a smart way," said Trey Ideker, PhD, professor at University of California San Diego School of Medicine and Moores Cancer Center. " In a paper published on October 20th, 2020 in Cancer Cell, Ideker and Brent Kuenzi, PhD, and Jisoo Park, PhD, postdoctoral researchers in his lab, describe DrugCell, a new artificial intelligence (AI) system they created that not only matches tumors to the best drug combinations, but does so in a way that makes sense to humans. Learn More

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Project Alert

Wuxi Biologics Unveils New PD Facility in King of Prussia, Pennsylvania


WuXi Biologics has announced the opening of a new process development and testing lab in King of Prussia, Pennsylvania. WuXi Biologics partnered with Discovery Labs and Integrated Project Services (IPS) to lease and renovate the 33,000-square-foot facility, which will include a development lab and shipping, delivery and storage space. The company has already hired more than 50 highly skilled employees to work at the facility, with plans to hire at least 50 more in the coming months. The King of Prussia site is the first of three WuXi Biologics facilities being opened in the United States. Learn More
 
Patent Alert

Method and Unit for the Sterile Filling of a Final Basic Container with Content Intended for the Biopharmaceutical Field


 
A U.S. Patent for "Method and Unit for the Sterile Filling of a Final Basic Container with Content Intended for the Biopharmaceutical Field" was awarded to Sartorius on October 6th, 2020The present invention is a method for the sterile filling of at least one final basic container, includes: providing at least one sterile chamber having at least one sterile entrance port and providing a source container containing the content, located outside the chamber; providing a communication element, a dispensing element and at least one filling member, to form when all are assembled, a sterile fluid filling and transfer line; inserting at least one final container into the chamber... Learn More

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Solution Alert

Do you know of a flow sensor that can be used with reinforced tubing? It would need to be non-invasive, I'm thinking a clamp-on would be ideal.


This is an increasingly common challenge that I'm pleased to get a chance to address. While most clamp-on flow sensors will make a claim to suitability for applications requiring braid reinforced tubing, few can deliver. That being said, I would recommend you take a look at the offering from Sonotec. I have actually heard first-hand from end users like yourself that their flow sensors work well with reinforced tubing. Here is a link to more information;
Fact Alert

To Shoot the Movie Babe Required 48 Actual Pigs


This was due to the rapid rate at which the pigs grow. Learn More

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Career Alert

 

Merck, Associate Director, Engineering Automation - West Point, PA
Manage a professional staff of ~ 14 engineers that provide process automation support to enable reliable and compliant supply of vaccines. Learn More

Aldevron Madison, Scientist III Fermentation, Process Development - Madison, WI
The ideal candidate leads complex projects in the areas of recombinant protein expression and fermentation, with an emphasis on methods development. Learn More

Bionova Scientific, Scientist II Cell Culture - Fremont, CA
This person will actively contribute to the development and technology transfer of projects at the Bionova Scientific West Warren site. Learn More

NewAge-AdvantaPure, Director of Product Management - Southampton, PA
This individual will lead a team of product managers to develop, propose and launch innovative products to meet customer demand and drive company growth. Learn More

Kerry, R&D Director, Pharma - Beloit, WI
The role entails managing a technical team with a focus on cell nutrition (cell culture and microbiology) in addition to having functional leadership responsibilities. Learn More