Explosion and Fire at Russian Research Center Studying Lethal Viruses

A major Russian research center studying lethal viruses including Ebola, Smallpox, HIV and the Plague, says there was no biological contamination from an explosion and fire in one of its buildings. The fire, which spread to roughly 300 sq. ft. before being extinguished, was caused by the explosion of a gas canister during refurbishment work at the Vektor Center in Koltsovo, a town near Novosibirsk in Siberia. The explosion, which occurred on the fifth floor of the six story lab building, blew out windows and sent one person to intensive care with severe burns.  A statement by Vektor notes that there was no major structural damage in the incident and "no work with biological materials was going on there". Learn More

Biogen Stops Phase 2 Study in Another Hit to ‘High-Risk’ Pipeline

Biogen has confirmed that it has ended a Phase 2b study early for an experimental treatment for idiopathic pulmonary fibrosis, or IPF, citing safety concerns with the drug. Analysts flagged the trial discontinuation earlier this week, which appears to have been the only active trial for the monoclonal antibody called BG00011 and, formerly, STX-100. Biogen determined the drug's benefit-risk profile "no longer met the criteria to continue the clinical trial," a company spokesperson said in a statement. Biogen acquired the antibody in 2012, when the company bought the privately-held biotech Stromedix for $75 million in upfront monies. Learn More

Sienna Bio Files for Bankruptcy

Sienna Biopharmaceuticals, a California based biopharmaceutical company, has filed for bankruptcy.  The clinical-stage biotech filed for Chapter 11 bankruptcy after several pipeline flops, including an issue with its experimental acne drug SNA-001 in 2017. Sienna expects to maintain business operations while looking for a strategic partner or purchaser. The company has listed its assets at $107.6 million and debts at $80.7 million in its Chapter 11 bankruptcy petition and hired both outside legal counsel and an investment bank to help it navigate the process. Learn More

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FDA Issues 53 Product-Specific Guidances to Help with Generic Drug Development

The US FDA this week released 53 product-specific guidance documents to aid generic drug development, including 34 new guidance documents, 26 guidances for treatments that lack generic competition and 16 for complex products. When finalized, the guidance documents will represent the current thinking of FDA on, among other things, the product-specific design of bioequivalence studies to support abbreviated new drug applications. This is the third time in 2019 that FDA has released new and revised guidance documents, with the previous releases occurring in May and February. 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: Scalable Purification Strategies for Viral Vectors and Vaccines

Thursday, September 19th, 2019

Large-scale downstream processing of viruses can face a range of obstacles different from those of many biotherapeutics. These challenges mostly arise from the size and complexity of the virus, which can affect product purity and recovery. Improvements of purification tools are necessary to overcome these challenges and must be engineered for easy scalability to meet manufacturing demands. Dr. Mark Snyder will discuss the difficulties when developing purification strategies for vaccine production and gene therapy. Dr. Snyder will explore innovative resin designs and functionalities and examine recent case studies and current processes that benefit from these resins and purification strategies.

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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

1973 Jimmy Carter Files Report on UFO Sighting

On this day in 1973, future President Jimmy Carter files a report with the National Investigations Committee on Aerial Phenomena (NICAP), claiming he had seen an Unidentified Flying Object (UFO) in October 1969. Carter promised that, if elected president, he would encourage the government release "every piece of information" about UFOs available to the public and to scientists. After winning the presidency, though, Carter backed away from this pledge, saying that the release of some information might have "defense implications" and pose a threat to national security. Learn More

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Why the Hospital of the Future Will be Your Own Home

Nobody likes going to the hospital, whether it's because of the logistical challenges of getting there, the astronomical costs of procedures or the alarming risks of complications like antibiotic-resistant bacteria. But what if we could get the lifesaving care provided by hospitals in our own homes? Health care futurist Niels van Namen shows how advances in technology are making home care a cheaper, safer and more accessible alternative to hospital stays. 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 Space Pen was Developed by NASA to Prevent Fires

Pencils contain graphite which is conductive and can cause short circuits and potentially fires.  Learn More