Inside the Chinese Lab Central to the Search for the Coronavirus' Origin

                                                                                          Issue # 3261 | August 11th, 2020     




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News Alert


Inside the Chinese Lab Central to the Search for 
the Coronavirus' Origin

Cloistered off a major thoroughfare, the Wuhan Institute of Virology could pass for a college campus, its red brick buildings distinguishable from their busy surroundings only by a long, imposing driveway lined with cameras, with a security guard standing sentry. On the neatly manicured grounds beside a small man-made lake is a newer structure with silver sidings and few windows. This, the institute's BSL-4 lab - the first in China to receive the highest level of biosafety clearance - stands at the center of an international firestorm of recrimination over China's role in the coronavirus pandemic. Recently, NBC News became the first foreign news organization to be granted access to the institute since the outbreak began. Learn More



Seres Finds the Microbiome Data It's Been Waiting For

A small biotech is worth more than four times what it was last week, thanks to a capsule filled with spores. Seres Therapeutics has become the first company to detail positive results from a pivotal study of a microbiome drug. The study looked at 182 patients with recurring infections from a bacterium called C. difficile, and found those who took Seres' capsule were significantly less likely to see their infections return. In fact, after eight weeks, nearly 90% of patients on the drug were without C. diff infections. Seres said the results provide enough support to submit its capsule for approval, putting the company in position to win the first-ever regulatory clearance for a microbiome-based drug. Learn More



FDA's Reopening Plan Will Keep Biologics Labs Shuttered Far Longer Than Other Government Labs

The FDA is keeping its biologics labs shuttered far longer than other government research labs, according to internal FDA documents obtained by STAT. FDA officials told staff last month that it will keep the labs, which research ways to improve the safety of existing vaccines and gene therapies, closed until there are fewer than 10 coronavirus cases per 100,000 people in the counties surrounding the agency's White Oak, Md., campus. Currently, just 16 states meet that metric. Learn More

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Quote Alert


On this Day Alert

1973  American Graffiti Opens


On this day in 1973, the nostalgic teenage coming-of-age movie American Graffiti, directed and co-written by George Lucas, opens in theaters across the United States. Set in California in the summer of 1962, American Graffiti was nominated for five Academy Awards, including Best Director and Best Picture, and helped launch the big-screen careers of Richard Dreyfuss and Harrison Ford, as well as the former child actor and future Oscar-winning filmmaker Ron Howard. The film's success enabled Lucas to get his next movie made, the mega-hit Star Wars (1977). Learn More

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TED Alert

The Past, Present and Future of Nicotine Addiction


Tobacco use remains the leading cause of preventable disease and death in the United States, killing more people each year than alcohol, AIDS, car accidents, illegal drugs, murder and suicide combined. Follow health policy expert Mitch Zeller into the murky depths of the tobacco industry as he details the sordid history of nicotine addiction -- and invites us to imagine a world where policy change helps stop people from becoming addicted in the first place. Learn More

Poll Alert

Should the US government ban the social video-sharing app TikTok on the grounds that it poses a national security threat?

Yes
No  


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Bioprocess Alert

BioProfile FLEX2 and BioProfile FLEX Linearity, Precision, and Comparability



This report summarizes linearity, precision, and comparability of the new generation BioProfile FLEX2 to the previous generation BioProfile FLEX cell culture analyzer. As part of the internal validation for BioProfile FLEX2, sample replicates for all measurable parameters (pH, pCO2, pO2, glucose, lactate, glutamine, glutamate, ammonium, sodium, potassium, and calcium) were analyzed across the full analytical range on both BioProfile FLEX2 and BioProfile FLEX. Twenty replicate samples of control material were also analyzed consecutively on BioProfile FLEX2 to determine precision. BioProfile FLEX2 provided a high degree of precision, accuracy, and comparability against BioProfile FLEX analyzer. BioProfile FLEX2 exceeded all validation criteria for release. Learn More

Market Alert


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Upstream Alert

An Additive Manufacturing Approach to Bioreactor Design for Mesenchymal Stem Cell Culture



Bioreactor design is a challenging endeavor that aims to provide the most ideal environment in which cells can grow and biological reactions can occur. The emergence of regenerative medicine and stem cell therapies has led to the need for more diverse environmental requirements in the bioreactor design space. The study presented uses an additive manufacturing approach for the initial design phase of a packed/fluidized bed bioreactor for mesenchymal stem cell expansion. Combining 3D-printing with CFD for precision control over the bioreactor flow dynamics. Novel flow distributors were developed to engender swirling particle fluidization. Learn More

Event Alert


Webinar: Efficient and Rapid Purification of E. coli Expressed Toxin Recombinant Protein Fragments

Wednesday, August 26th, 2020

Presenter: Andrew Lees, PhD
                  Founder and Scientific Director 
                  Fina Biosolutions

In this brief webinar, Dr. Lees will present a case study on a purification process for rTTHc using polymeric chromatography resins. rTTHc was expressed at high levels as a soluble, properly folded intracellular protein in Fina Bio proprietary Escherichia coli strain. The protein has a molecular weight of 50 kDa with pI ~6. Multiple resins were screened using an automated chromatography system. Nuvia Q anion-exchange (AEX) resin (120 µm) was selected as the capture step and Macro-Prep Methyl hydrophobic-interaction chromatography (HIC) resin selected for polishing step. This two-step purification protocol was optimized for scale-up, resulting in >98% pure purified target protein.


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Downstream Alert

Final Filling



In this case study the author, AdvantaPure, describes the design and implementation of a custom molded filling assembly used in final fill. The primary objective of the customer was to re-design the current filling process to minimize potential assembly leak points and maintain sterility assurance level (SAL 10-6). Additionally, the customer was looking to maximize throughput and repeatedly produce accurate fill volumes. Learn More

Podcast Alert
 
Cancer and Evolution



In this episode of Stuff to Blow Your Mind, Joe chats with Kat Arney about her upcoming book "Rebel Cell: Cancer, Evolution, and the New Science of Life's Oldest Betrayal." Learn More

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Regulatory Alert


FDA Guides Drug-Drug Interaction Studies for Therapeutic Proteins

A new draft guidance from the US FDA gives industry direction in how to assess drug-drug interactions for therapeutic proteins. The guidance, issued jointly by the Center for Drug Evaluation and Research (CDER) and the Center for Biologics Evaluation and Research (CBER) recommends that sponsors use a "systematic, risk-based" approach to determine whether their therapeutic protein candidates for investigational new drug applications (INDs) and biologic license applications (BLAs) require drug-drug- interaction studies. The draft document covers therapeutic proteins (TPs) licensed as therapeutic biological products, but the FDA notes that the general concepts could be applicable to other biological products. Learn More
 
Discovery Alert


Mouthwashes Could Reduce the Risk of Coronavirus Transmission, Study Shows

Sars-Cov-2 viruses can be inactivated using certain commercially available mouthwashes. This was demonstrated in cell culture experiments by virologists from Ruhr-Universität Bochum together with colleagues from Jena, Ulm, Duisburg-Essen, Nuremberg and Bremen. High viral loads can be detected in the oral cavity and throat of some Covid-19 patients. The use of mouthwashes that are effective against Sars-Cov-2 could thus help to reduce the viral load and possibly the risk of coronavirus transmission over the short term. This could be useful, for example, prior to dental treatments. However, mouth rinses are not suitable for treating Covid-19 infections or protecting yourself against catching the virus. Learn More

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Project Alert



MeiraGTx Planning Major Expansion in Ireland
 
MeiraGTx has announced plans to significantly expand its manufacturing facility in Shannon, Ireland. The expanded facility will be designed for the manufacture of commercial-grade gene therapies. The facility will cover roughly 90,000 sq. ft. (8,300 sq. meters) in two separate buildings and will be designed to meet global regulatory requirements, including the US FDA. The unit at Shannon will be used for the manufacture of MeiraGTx viral vectors for gene therapies and the plasmid DNA that is one of the starting materials in viral vector production. The plasmid production facility is expected to be operational by the end of 2020, and the second viral vector manufacturing facility to be operational by the end of 2021. Learn More

Patent Alert



Protein Purification by Anion Exchange Chromatography
 
A U.S. Patent for "Protein Purification by Anion Exchange Chromatography" was awarded to Baxalta on July 28th, 2020The present invention is a method for the purification of a divalent cation binding protein comprising the steps of: (a) loading a first anion exchange resin material with the divalent cation binding protein in a loading buffer in the absence of divalent cations or at a low concentration thereof; (b) washing the loaded anion exchange resin material with a washing buffer comprising between 175 mM NaCl and 190 mM NaCl in the absence of divalent cations; (c) eluting the divalent cation binding protein with an eluant comprising a counter-anion... Learn More

Solution Alert



Do you know of a study of rocker-based bioreactor platforms that addresses the fundamentals like fluid mixing and mass transfer? No marketing materials or sponsored whitepapers please, something done independently.

You definitely know what you want, or don't want as the case may be, and I think I have found it. A 202-page doctoral of engineering thesis prepared at University College London with the support not of the manufacturer but of no less an independent source than Eli Lilly. Complete with chapters dedicated to fluid mixing, mass transfer and so much more. Here is a link to more information;
 
Fact Alert

Canada Only Gained Full Independence from the United Kingdom in 1982


The Canada Act 1982 is an act of the Parliament of the UK which "patriated" Canada's constitution, ending the power of the British Parliament to amend the Constitution of Canada. Learn More
 
Career Alert

 

Genentech, Manufacturing Technician, Bioprocess - Vacaville, CA
Work will occur in a clean room environment and involve routine production of mammalian cell culture products within the Vacaville Manufacturing Facility. Learn More

Emergent Biosolutions, Sr. Director, Drug Substance Development - Gaithersburg, MD
This person will lead a team of Drug Substance Subject Matter Experts developing solutions for complex problems across all aspects of the biopharma process. Learn More

Catalent Pharma Solutions, Manufacturing Supervisor - Harmans, MD
Responsible for supporting the overall GMP upstream or downstream manufacturing process, through the application of broad knowledge. Learn More

Banks Integration, Automation Engineer, DeltaV - Oceanside, CA
We are looking for an experienced engineer to work within a project team to develop, program, and commission equipment running on a DeltaV platform. Learn More

AbbVie, Scientist I/II, Biologics, Protein Purification - Lake County, IL
The candidate should have proficiency in all standard bioprocess and chromatography techniques, and have the ability to drive process development activities. Learn More