Alexion’s CFO Steps Down in Surprise Departure

Alexion finance chief Paul Clancy will step down from running the rare disease biotech's books, the company unexpectedly announced this week, setting in motion a succession plan that will promote current head of business development Aradhana Sarin to chief financial officer.  Clancy, who joined Alexion in June 2017 after serving as Biogen's CFO for a decade, was part of an executive team brought in to refocus the company after a damaging stretch in which senior management was blamed for improperly pressuring staff to meet sales targets. The departure comes as a surprise to many and Clancy does not appear to be retiring from industry according to reports. Learn More

U.S. Senators Urge FTC to Scrutinize Multi-Billion Dollar Pharma Mergers

U.S. Senator Amy Klobuchar leads a letter by U.S. senators that urges the Federal Trade Commission (FTC) to closely scrutinize pharma mergers, raising concerns about the potential harm to customers. They also raised concerns that the deals may reduce innovation in drug development and give the merged companies increased negotiating leverage to secure positions on drug formularies and greater ability to condition buyers' access to their multi-billion-dollar drugs. As Alert readers know, the biopharma industry has seen a string of multi-billion-dollar deals and consolidation is expected to remain a major theme for the rest of the year. Learn More

FDA Lays Out Tech Modernization Action Plan

As part of efforts to prepare for the continued rise in data-rich applications and to help fill the gap separating scientific advances and new therapies, the US FDA has unveiled its Technology Modernization Action Plan (TMAP). Near-term modernization in computer hardware and software technologies are the focus of FDA's TMAP, which offers a broad overview of how the agency needs to adapt. For instance, the TMAP report notes that FDA will need to have a technical infrastructure that can accept, evaluate and analyze novel sources of data (e.g., real-world data) and apply that data to regulatory decision making over the next several years. Learn More

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FDA Lays Out Tech Modernization Action Plan

As part of efforts to prepare for the continued rise in data-rich applications and to help fill the gap separating scientific advances and new therapies, the US FDA has unveiled its Technology Modernization Action Plan (TMAP). Near-term modernization in computer hardware and software technologies are the focus of FDA's TMAP, which offers a broad overview of how the agency needs to adapt. For instance, the TMAP report notes that FDA will need to have a technical infrastructure that can accept, evaluate and analyze novel sources of data (e.g., real-world data) and apply that data to regulatory decision making over the next several years. Learn More

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Continuous In-Line Virus Inactivation for Next Generation Bioprocessing

Viral inactivation plays a critical role in assuring the safety of monoclonal antibody (mAb) therapeutics. Traditional viral inactivation involves large holding tanks in which product is maintained at a target low pH for a defined hold time. The drive toward continuous processing and improved facility utilization has provided motivation for development of a continuous viral inactivation process. To this end, a lab-scale prototype viral inactivation system was designed, built, and characterized. Multiple incubation chamber designs are evaluated to identify the optimal design that enables narrow residence time distributions in continuous flow systems. Learn More

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Do you know if any of the companies that make conventional reusable sensors for pH and DO are offering single-use versions? I need to specify a sensor manufacturer to our bioreactor bag supplier who can work with them to get the sensor integrated into the bag before we receive it.

Not to put too fine a point on it but you are looking for the wholly grail of single-use sensing, and you just might have found it. Industry leaders Hamilton and Mettler Toledo have both addressed this need and I have seen where Broadley James is working with Pall on a solution that was in Beta testing as of this past Spring. Here are links to more information;

Hamilton Single Use

Mettler Toledo Single Use

Broadley James Single Use

Continuous Pharmaceutical Manufacturing: Current Trends and Future Possibilities

This video provides information and insights from end users and suppliers alike on the current trends, and future possibilities, associated with continuous manufacturing.

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Webinar: Raman Spectroscopy for Cell Culture Process Monitoring and Multi-Feed Control

Presenter: Dr. Tom Eyster, Investigator, GSK

Tuesday, September 24th, 2019

In a novel study, Raman spectroscopy was used by GSK to implement simultaneous feedback control of glucose and lactic acid in a 3L CHO bioprocess producing a monoclonal antibody (mAb). Lactic acid feeding to a setpoint of 2 g/L led to a substantially lower level of ammonium and CO2 accumulation. Additionally, from a quality standpoint, higher galactosylation of the mAb was observed with lactic acid control. Therefore, this study shows evidence that the implementation of Raman as a process control tool provides the capability to tune product quality by impacting cell metabolism. In conclusion, this work demonstrates the power of Raman spectroscopy for not only real-time process monitoring, but also implementing feedback control for product quality tuning.

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Cancer Drugs Don’t Always Work as Intended, Researchers Warn

Scientists at Cold Spring Harbor Laboratory (CSHL) have identified 10 cancer drugs currently in clinical trials that do not work how clinicians thought they would. In identifying what went wrong, experts can now work to improve drug discovery and personalized medicine. The discovery started out with an entirely different goal. Over the past few years, CSHL Fellow Jason Sheltzer's lab has been working to identify genes tied to low survival rates among cancer patients. During this work, the researchers discovered that MELK, a protein often found in high levels in tumors, has absolutely no influence on cancer growth. Learn More

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Seeding an Adherent Cell Bioreactor with Non-Adherent Cells Increases Seeding Density Limit and Reduces Required Expansion Time

A U.S. Patent Application for "Seeding an Adherent Cell Bioreactor with Non-Adherent Cells Increases Seeding Density Limit and Reduces Required Expansion Time" was published by Trizell on September 12th, 2019. The present invention is a counter-intuitive way to improve the commercial-scale production of recombinant biological products in adherent-cell bioreactors, which reduces the risk of cell culture contamination, increases total yield and reduces the delay between seeding and harvest, thus minimizing expression product degradation, by inter alia inoculating an adherent culture bioreactor with suspension-adapted producer cells. Learn More

1959 Khrushchev Barred from Visiting Disneyland

On this day in 1959, Soviet leader Nikita Khrushchev learned that he would not be allowed to visit Disneyland. Government authorities feared that the crowds would pose a safety hazard for the premier. Khrushchev exploded, yelling "And I say, I would very much like to go and see Disneyland. But then, we cannot guarantee your security, they say. Then what must I do? Commit suicide? What is it? Is there an epidemic of cholera there or something? Or have gangsters taken hold of the place that can destroy me?" Khrushchev left Los Angeles the next morning. Learn More

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Shouldn’t Sports be Color-Blind?

Sports should be the great racial equalizer, a place where meritocracy reigns and skin color is irrelevant. But journalist Patrick Ferrucci begs to differ. Using sports journalism as his lens, he demonstrates how racial stereotypes have infiltrated the language we use to discuss athletes -- and how everyday racism bleeds into other aspects of life too. Learn More

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New 100,000 Square-Foot Building Planned for Biotech Park

Activation Capital, a nonprofit affiliated with the 34-acre VA Bio+Tech Park, has filed plans with the city of Richmond to build a six-story, 100,000-square-foot research building at 706 E. Leigh St. The building will occupy a roughly 2-acre block bounded by East Jackson, East Leigh, North Seventh and North Eighth Streets. Plans also show a 740-space parking deck. The project  awaits city approval. The property is already zoned with the same designation as other properties in the park, meaning it likely won't require a rezoning or special-use permit. Learn More

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The Aztec’s Created a Whistle in the Shape of Skulls Called a Death Whistle

It produces a horrifying sound, but its exact purpose is unknown. Experts think they may have been used during battle or as part of sacrificial ceremonies.  Learn More