Novartis to Build $55M Gene Therapy Manufacturing Facility

                                                                                          Issue # 2691 | May 25th, 2018      

























































































































































News Alert



Novartis to Build $55M Gene Therapy Manufacturing Facility in North Carolina

AveXis,  recently acquired by Novartis for $8.7 billion, will invest  $55 million to build a new manufacturing facility in Durham, North Carolina. The facility will create 200 jobs and offer employees a signfiicantly competitive salary. AveXis will use the new site to make its first product candidate, AVXS-101, a gene therapy to treat three types of spinal muscular atrophy (SMA). Durham was competing with the state of Illinois for the site. Illinois approved tax credits of almost $8 million to bring the jobs to Libertyville, Illinois. But instead, AveXis took a $3 million incentive package in North Carolina.




Merck's Successful Appeal to the U.S. Supreme Court Appears More Likely 

Merck & Co.'s effort to take its Fosamax appeal to the Supreme Court just got a boost, and the entire biopharma industry should take note. The U.S. Solicitor General is urging the justices to take on the appeal, which centers on a set of closely watched lawsuits alleging Merck failed to fully flag the risks of its osteoporosis drug Fosamax. If the high court hears the drugmaker's appeal, its decision could ripple through product liability lawsuits across the drug business. That's because at its heart is the issue of preemption, which is to say whether FDA decisions can protect drugmakers from state-level legal challenges.  Learn More




Venture Capitalists Put $260 Million Into New Chinese Biotech

A group of venture capitalists have put $260 million into a new Shanghai biotechnology firm, Brii BioSciences, that will develop new medicines exclusively for the Chinese market. "The company I am trying to build is only going to do China," says Brii Chief Executive Zhi Hong. "I will not have any other market." For 11 years, Hong has headed infectious disease drug development at GSK, where he spearheaded a turnaround that resulted in one of the company's biggest recent successes, Tivacay, for HIV. The new company will be focused not on drug discovery but on clinical trials, regulatory approvals, and commercialization.  Learn More

Quote Alert



On this Day Alert

1977 Star Wars Released


The release of Star Wars on a holiday weekend in the States, and the resulting hundreds of millions in sales directly, and billions in sales indirectly, effectively redefined the term "Blockbuster". The term had been coined just two years earlier to describe"Jaws".  Learn More

TED Alert

Better Baby Care - Thanks to Formula 1


During a Formula 1 race, a car sends hundreds of millions of data points to its garage for real-time analysis and feedback. So why not use this detailed and rigorous data system elsewhere, like at children's hospitals? Peter van Manen tells us more.  Learn More

Poll Alert

Is serving on a jury part of what it means to be a good citizen?
     



Bioprocess Alert

How to Use an Autoclave


This video, which has 130,000+ views, demonstrates the use of an autoclave to sterilize materials in the lab. For this demonstration, 2 common applications: 1. Sterilize a solution using slow exhaust. 2. Sterilize and dry some empty glassware using fast exhaust, are conducted.  Learn More

Market Alert



Event Alert: Webinar



Finding the Common Road to Quality for Single Use Materials

Wednesday, June 6th, 2018
 
GMP requirements touch every single use assembly used, from clinical studies to commercial manufacturing and everything in between. As such, it is imperative that GMP practices be followed when producing these single use assemblies so as to ensure there is no risk to patients in clinical trials and with future commercial products. Failing to do so will further the perception of some that there are inadequate quality controls on single use assemblies which will lead to the use of said assemblies not being accepted by regulatory agencies and internal quality departments.


Spotlight Alert



A New pH-Responsive Peptide Tag for Protein Purification

This paper describes a new pH-responsive peptide tag that adds a protein reversible precipitation and redissolution character. This peptide tag is a part of a cell surface protein B (CspB) derived from Corynebacterium glutamicum. 
Proinsulin that genetically fused with a peptide of N-terminal 6, 17, 50, or 250 amino acid residues of CspB showed that the reversible precipitation and redissolution depended on the pH. The transition occurred within a physiological and narrow pH range. A CspB50 tag comprising 50 amino acid residues of N-terminal CspB was further evaluated as a representative using other pharmaceutical proteins...  Learn More


Regulatory Alert



Novartis Receives EU Approval for Biosimilar Zessly

Novartis has announced that its Sandoz division received approval from the European Commission for its biosimilar Zessly (infliximab). Zessly is approved for use in all indications of the reference medicine including rheumatoid arthritis, adult and pediatric Crohn's disease, adult and pediatric ulcerative colitis, ankylosing spondylitis, psoriatic arthritis and plaque psoriasis according to Novartis. Zessly is the sixth approved biosimilar medicine for Sandoz, with several more major oncology and immunology launches expected globally by 2020. Learn More

Discovery Alert



Researchers Identify Gene That Helps Prevent Brain Disease

Scientists know that faulty proteins can cause harmful deposits or "aggregates" in neurological disorders such as Alzheimer's and Parkinson's disease. Although the causes of these protein deposits remain a mystery, it is known that abnormal aggregates can result when cells fail to transmit proper genetic information to proteins. University of California San Diego Professor Susan Ackerman and her colleagues first highlighted this cause of brain disease more than 10 years ago. Now, probing deeper into this research, she and colleagues have identified a gene, Ankrd16, that prevents the protein aggregates they originally observed. 


Project Alert



AstraZeneca Opens New Facility in Bay Area

AstraZeneca announced this week that it has opened a new facility in South San Francisco. The facility will combine Bay Area employees from Acerta Pharma, MedImmune, Pearl Therapeutics and AstraZeneca's TIDE group. Both Acerta and Pearl were previously in Redwood City, California while the Medimmune employees will be transitioning from a site in Mountain View, California. It should be noted that roughly 400 employees in the Bay area began moving into the new site at the end of last year. Learn More

Patent Alert



Methods for Reducing Aggregate Content in Protein Preparations

A U.S. Patent for "Methods for Reducing Aggregate Content in Protein Preparations"  was awarded to ASTR  on May 22nd , 2018 The present invention is a method of reducing aggregate and product-contaminant complex content in a protein preparation including a desired protein includes (i) contacting the protein preparation with at least one solid surface comprising at least one surface-bound ligand capable of binding a metal, the surface-bound ligand being capable of binding a metal is initially substantially devoid of a metal, the operating conditions are selected to substantially prevent the binding of the desired protein to the at least one solid surface... Learn More


Xchange Alert



Development of a Recursive Time Series Model for Fed-Batch Mammalian Cell Culture 

Recursive time series models are developed in this work for a fed-batch mammalian cell culture producing monoclonal antibodies, with key culture variables measured at different sampling frequencies. Glucose and glutamine feed rates are considered as inputs. The data required for parameter estimation are generated from simulated fed-batch experiments using a well-tested first principles model. The predictions for glucose, glutamine, and viable cell concentrations track very well the data for these, with the errors for the high prediction horizons considered being limited to 10% or less. The prediction accuracy can be increased further if data from prior experiments with dynamic similarities are available. Learn More


Career Alert
 
Bristol-Myers Squibb
Devens, MA.

Genomatica
San Diego, CA.

Regeneron
Tarrytown, NY.

Genentech
Vacaville, CA.

JSR Life Sciences
Research Triangle Park, NC.

Cole-Parmer
Vernon Hills, IL.


Fact Alert

"Nope" Adds a Button to Your Browser that Calls You When You Click It


Once you answer the phone, you hear instructions on how to look like you're sorry you had to take an "important" call, and hopefully they'll get the hint and leave you alone.  Learn More