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American Pharmaceutical News In Review
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September 08, 2021
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  Introducing the CTech FlowVPX System for In-line Concentration Measurement

Take control of your process with the FlowVPX System. Our newest in-line variable pathlength solution for GMP manufacturing delivers high quality and highly reproducible results enabling increase process understanding, improved cycle time and reduction in-process control testing efforts. The in-line Slope Spectroscopy® method enables users to monitor and optimize critical process parameters and make real-time decisions for enhanced biologic product consistency and quality. Eliminate off-line measurements, out-of-spec results, and costly and time-consuming deviation reports by incorporating the FlowVPX System as part of your in-process control strategy.

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» Industry News
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  FDA Launches Novel Excipient Review Pilot Program
The FDA introduced a new pathway for manufacturers to obtain FDA review of certain novel excipients ... read more »
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  Merck’s KEYTRUDA® (pembrolizumab) Approved in China for First-Line Treatment of Patients With GEJ Carcinoma
Merck’s anti-PD-1 therapy was approved by the National Medical Products Administration (NMPA) in ... read more »
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  Dr. Reddy’s Laboratories Sells Anti-Cancer Agent E7777
Dr. Reddy’s Laboratories announced a definitive agreement with Citius Pharmaceuticals. Citius now ... read more »
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  Purdue Pharma L.P. Regorganizes into New Company – “Knoa Pharma”
Following the United States Bankruptcy Court approval of the Purdue Pharma L.P. chapter 11 plan of ... read more »

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» Infographic
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  Considerations to Get the Most Accurate TOC Performance Using Real Time Online Measurement
On-line, continuous Total Organic Carbon (TOC) monitoring has become the gold standard for detecting TOC in pharmaceutical ultra-pure water systems. ... read more »
» Featured Articles
Countering Misinformation Spread About the COVID-19 Pandemic
Today it’s a free-for-all on social media, which has become the main source of information for people on the COVID-19 pandemic, and sometimes a major ... read more »
Quantification of Residual Host Cell DNA in Protamine Sulfate Drug Product Using Droplet Digital PCR
Protamine Sulfate (ProS) is the only FDA approved anticoagulation reversal agent for unfractionated heparin. ProS is biologically derived from chum ... read more »
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» Featured Video
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  On-Demand Webinar: Development and Validation of a Platform Assay Method Using Variable Pathlength Technology for Oligonucleotide Drug Products
This webinar will share Ionis’ experience with developing and validating a platform SoloVPE® in-process assay method for GMP manufacturing of ... watch »
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  On-Demand Webinar: Clarifying Pharmacopeial Requirements for Pharma Waters and Process Analytics
In this webinar you’ll learn answers to common questions to distinguish actual pharmacopeial requirements for pharmaceutical waters vs what has become... watch »

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» Featured Products
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  Sievers Eclipse Bacterial Endotoxins Testing (BET) Platform
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» Featured Whitepaper
Accelerating mRNA-based Therapy Development with Scalable Purification of In-Vitro Transcribed mRNA
The potential of mRNA in therapies seems to be endless but obtaining larger quantities of synthetic mRNA for clinical treatment remains a challenge. The current available methods for mRNA purification... read more »

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| Events
EVENT
  SMi’s Aseptic Processing Conference
London, UK –  09/20/2021
The aseptic processing industry has seen many changes during its progression towards the 21st century. With advances in innovative therapeutic ...
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EVENT
  Wearable Injectors and Connected Devices Conference 2021
London, UK –  10/18/2021
SMi’s 2nd annual Wearable Injectors and Connected Devices Conference will explore real world case studies of on-body device design and development for...
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