Moderna Opens New 200,000 Sq. Ft. Manufacturing Site

                                                                                          Issue # 2729 | July 18th, 2018      
















































































































































































News Alert



Moderna Opens New 200,000 Sq. Ft. Manufacturing Site

Moderna Therapeutics this week opened its new state-of-the-art manufacturing facility in Norwood, Massachusetts. The digitally-enabled and environmentally sustainable 200,000 square foot clinical development manufacturing plant was built to advance Moderna's pipeline of mRNA-based medicines. Designed to Current Good Manufacturing Practices (cGMP) specifications, the site gives the company the capacity to develop materials for preclinical toxicology studies as well as Phase 1 and 2 clinical development programs, and to manufacture, test and run fill/finish operations for its portfolio of mRNA development candidates.




Mylan Signs U.S. License Deal on Humira with AbbVie

AbbVie has announced a licensing deal with Mylan for its proposed biosimilar to Humira. The deal provides Mylan with rights that begin on July 31st, 2023. It calls for Mylan to pay royalties to AbbVie beginning in 2023 while requiring no payments from AbbVie. In an interesting aside, there is no acceleration clause in the deal should rival products from Amgen or Samsung enter the market.  The move is seen as giving AbbVie more near-term control over the competition.
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FDA Issues Warning Letter to Baxter Owned Injectables Manufacturing Site

The U.S. FDA this week published a warning letter sent July 5th, 2018 to a Baxter-owned manufacturing site following a nine-day inspection last July and August. In two instances, the Claris Injectables Ahmedabad, India based site, was found to have invalidated out-of-specification (OOS) results without adequate investigation and scientific justification. Alert readers will recall that Baxter the site as part of a more than $600 million acquisition that closed in July 2017. In a statement, Baxter notes that its ownership of the site had occurred just hours after the FDA's inspection had already begun but said it was committed to fully implementing the requisite corrective and preventive actions.  Learn More

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Quote Alert



On this Day Alert

1986 Video of Titanic wreckage released


Taken on the first manned expedition to the wreck, videotapes of the sunken ocean liner were relased to the public.
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TED Alert

What Happens in Your Brain When You Pay Attention?


Attention isn't just about what we focus on -- it's also about what our brains filter out. By investigating patterns in the brain as people try to focus, computational neuroscientist Mehdi Ordikhani-Seyedlar hopes to build computer models that can be used to treat ADHD and help those who have lost the ability to communicate. Hear more about this exciting science in this brief, fascinating talk.  Learn More

Poll Alert

Has college been a good investment for you?
     


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Bioprocess Alert

Overview of Lactate Formation and Recycling


This video, which has 22,000+ views, provides an overview of lactate formation and the associated recycling.  Learn More

Market Alert


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Event Alert



Ceramic Hydroxyapatite Chromatography Media - How to Start

Wednesday, July 18th, 2018

In this webinar our expert, Dr. Mark Snyder, will discuss the application use of CHT XT at process-scale and provide guidelines on where to start when selecting a hydroxyapatite media for your purification.  Our newest mixed-mode media, Ceramic Hydroxyapatite XT, is a calcium affinity cation exchange chromatography media. It is used for the purification of numerous types of biomolecules and provides single-step clearance of impurities and aggregates for monoclonal antibody purification. CHT XT is an easy-to-use mixed-mode chromatography media. Unlike other chromatography media it is both the ligand and the support matrix.

Topics to be discussed:
  • Introduction of hydroxyapatite mixed-mode media
  • Monoclonal antibody purification
  • Virus purification
  • Guidelines for selecting hydroxyapatite media


Resource Alert



Integrated Continuous Biomanufacturing Platform with ATF Perfusion and One Column Chromatography Operation for Optimum Resin Utilization and Productivity

A new integrated continuous biomanufacturing platform for continuous production of antibodies at fixed cell volumes and cell concentrations for extended periods with immediate capture is presented. Upstream antibody production has reached technological maturity, however, the bottleneck for continuous biomanufacturing remains the efficient and cost-effective capture of therapeutic antibodies in an initial chromatography step. In this study, the first successful attempt at using one-column continuous chromatography (OCC) for the continuous capture of therapeutic antibodies produced through alternating tangential flow perfusion is presented...  Learn More

 
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Regulatory Alert



FDA Announces Voluntary Recall of Drugs Containing Valsartan

Earlier this month, the European Medicines Agency (EMA) initiated recalls of certain valsartan-containing medicines with active substance supplied by China-based Zhejiang Huahai Pharmaceuticals, pending a review of an impurity. Now the U.S. FDA is announcing a similar voluntary recall. Both recalls are due to an impurity, N-nitrosodimethylamine (NDMA), which was found in the recalled products. However, the FDA says, not all products containing valsartan are being recalled.  Learn More

Discovery Alert



Study Finds Potential DNA Damage from CRISPR "Seriously Underestimated"

Research published this week in Nature suggests that CRISPR-Cas9 can cause significantly greater genetic havoc than experts thought, the study concludes, perhaps enough to threaten the health of patients who would one day receive 
CRISPR-based therapy. The DNA damage found in the new study included deletions of thousands of DNA bases, this includes deletions at spots far from the edit. Some of the deletions can silence genes that should be active while activating genes that should be silent, including genes know to cause cancer.  Learn More

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Project Alert



BMS Site in Wallingford Could be Demolished

The soon to be former BMS site in Wallingford, Connecticut could see its single massive building demolished and repalced with two smaller industrial buidlings if a suitable tenant cannot soon be found. This comes amid news that BMS has filed a WARN notice with Connecticut detailing plans to eliminate an additional 149 staffers at the site between now and mid-August. Alert readers will recall that the real estate firm Calare Properties acquired the 915,000 sq. ft. BMS complex earlier this year and that BMS plans to vacate the site by years end.  Learn More

Patent Alert