The FDA has shelved its National Priority Voucher pilot, leaving sponsors that built CMC and launch-readiness plans around 1- to 2-month reviews facing uncertain timelines.
News|Articles|July 2, 2019
- Pharmaceutical Technology-07-02-2019
- Volume 43
- Issue 7
Plate Reader Offers Real-Time Detection and Analysis
Tecan’s Spark Cyto cell plate reader offers real-time detection and analysis of biological, chemical, and physical events while consistently capturing the maximum amount of data from every well.
Tecan’s Spark Cyto cell plate reader offers real-time detection and analysis of biological, chemical, and physical events while consistently capturing the maximum amount of data from every well.
The device combines the flexibility of a high-end multimode plate reader with whole well imaging and comprehensive environmental control for cell-based assays. Capable camera components and a patent-pending LED autofocus system provide real-time data acquisition and analysis for 6- to 384-well formats.
The reader allows qualitative and quantitative information to be integrated into multiparametric data sets, delivering insights faster than previously available, the company states. With three magnification levels and four acquisition channels, the device enables entire cell populations to be investigated by capturing the whole well area of 96- or 384-well microplates in just one image without tiling or distortion.
Articles in this issue
over 7 years ago
Playbooks Are Not Just Child’s Playover 7 years ago
New Line of Rotary Valvesover 7 years ago
Planetary Dual Dispersers and Advanced Discharge Systemsover 7 years ago
Updated Pump Headover 7 years ago
FDA Revamps Biosimilar Quality Requirementsover 7 years ago
Automating Quality Checksover 7 years ago
Considerations for Sterile Filtration of Biologic Drugsover 7 years ago
Gene Therapies Propel Outsourcing Investmentover 7 years ago
A Biologics Partisan DivideRelated to this article
Regulators will test pharma companies against their own internal AI policies. Jaenisch, Muraru, and Pandey explain how to build defensible, inspection-ready AI practices.
Terry Katz, CEO and co-founder of ForgeStop Technology Corporation, explains how its connected technology can enhance anticounterfeiting and how data are handled within the product.
Celtic Renewables won the CPHI Award for Sustainable Pharma Excellence for its green chemicals used in pharmaceutical manufacturing. Bettina Brierley, chief commercial officer, talks about the adoption, capacity, and pricing of biosolvents.
Terry Katz, CEO and cofounder of ForgeStop Technology Corporation, explains the company’s CPHI Award-winning connected product technology and how it helps to combat drug counterfeiting.
FDA approved pimicotinib for TGCT based on a 56% response rate; its Project Orbis review signals tighter global launch planning for manufacturers.
Bettina Brierley, chief commercial officer at Celtic Renewables, discusses commercialization of biosolvents for pharmaceutical manufacturing.
From AI validation to microstructure imaging, AAPS PharmSci 360 speakers pushed toward faster drug development backed by stronger evidence. Here are PharmTech's biggest takeaways.
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