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American Pharmaceutical News In Review
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February 25, 2021
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  [Webinar] Integrated Production Process of mRNA from E. coli to Highly Purified mRNA
In vitro transcription (IVT), the enzymatic process used for mRNA vaccines' production, is different from from biological fermentation processes as it requires linearized plasmid DNA. The linear isoform is produced with restriction enzymes from open circular and supercoiled pDNA. Employing a traditional pDNA manufacturing process, which removes linear and open-circular isoforms, will reduce the production yield. However, when pDNA and mRNA are treated as a single production process, the purification steps can be optimized, yields improved, and the overall production cost reduced. This will be presented in this webinar.

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» Industry News
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  The Antares Vision Group Acquires rfXcel Corporation
Antares Vision has entered into an agreement for the acquisition of rfXcel Corporation, a US-based ... read more »
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  AstraZeneca Withdrawals Imfinzi Indication in Advanced Bladder Cancer
AstraZeneca announced the voluntary withdrawal of the Imfinzi indication in the US for previously ... read more »
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  OTIVIDEX Trial for Ménière’s Disease Does Not Meet Primary Endpoint
Otonomy announced the Phase 3 clinical trial of OTIVIDEX in patients with Ménière’s disease did not ... read more »
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  Intra-Cellular Therapies Applies for FDA Approval of CAPLYTA for Bipolar Depression
Intra-Cellular Therapies has recently submitted sNDAs to the FDA for two indications for CAPLYTA. read more »
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  BrainStorm Receives FDA Feedback on ALS Clinical Development Program
BrainStorm recently met with senior leadership from the FDA and received feedback on a high-level ... read more »
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  Gala Therapeutics Receives FDA Approval for RheOx Trial for Chronic Bronchitis
Gala has announced the FDA conditional IDE approval to commence its pivotal clinical trial called ... read more »

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» QC Corner
QC Corner
  Horseshoe Crab Sustainability Project
In this poster video, Brett Hoffmeister, the LAL Production Manager from the Associates of Cape Cod ... read more »
QC Corner
  Rely on Data, Not Lore to Meet Rising Demand
The COVID-19 pandemic has forced countless difficult decisions to be made in the face of ... read more »

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» Featured Articles
Reader Survey: Vaccine Manufacturing
As the industry focuses its efforts to bring COVID-19 treatments swiftly to market, there is renewed interest in the development and manufacturing of ... read more »
Pharmaceutical P.I.N. Points Patent Innovation News
The purpose of this column is to highlight and summarize recent key patents in the pharmaceutical arena issued by the US Patent Office from August-... read more »
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» Featured Video
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  On-Demand Roundtable: A Quality Perspective Roundtable Discussion on the Successes and Challenges of Making Changes to Pharma Workflow
In this roundtable you’ll learn about challenges faced by pharmaceutical quality teams in their material analysis workflows, and real-world solutions,... watch »
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  On-Demand Webinar: Development and Validation of a Duplex qPCR assay for the Detection of Residual Sf9 Host Cell DNA and Baculovirus DNA
In this webinar, you will learn more about current regulatory requirements for residual host DNA clearance for biological products and what that means... watch »

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» Featured Products
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  MAS-100 ISO NT Microbial Air Sampler
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  BacT/ALERT 3D Microbial Detection System
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» Featured Whitepaper
White Paper: Validation Guidance for Residual Host Cell DNA Testing of Biologics
Assurance of product safety and quality are top of mind for all biotherapeutic manufacturers read more »
eBook: Slope Spectroscopy Method
The SoloVPE System is an innovative instrument for the UV-VIS-NIR spectroscopy. read more »

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| Events
EVENT
  IFPAC - 2021
Virtual –  02/28/2021
IFPAC - 2021 will be held February 28 - March 5, 2021 LIVE, REAL-TIME event. The goal of IFPAC remains to support, connect, and unite our Community. ...
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EVENT
  Pittcon 2021
Virtual –  03/08/2021
Pittcon is a dynamic, transnational exposition and comprehensive technical conference, a venue for presenting the latest advances in research and ...
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