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American Pharmaceutical News In Review
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September 09, 2024
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  Ensuring Regulatory Compliance in Cell Therapies from Lab to Bedside

Bringing a new cell therapy treatment to market requires innovative and compliant solutions that can accelerate progress from the lab, all the way to the patient, safely and cost effectively. To streamline regulatory submission and smooth the transition from R&D toward manufacturing, it is crucial to maintain comprehensive and precise electronic records from the lab equipment used. Learn about solutions that can simplify 21 CFR Part 11 compliance in a cell therapy workflow in this video.

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» Industry News
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  FDA Approves Travere Therapeutics’ FILSPARI® for Kidney Disease
Travere Therapeutics announced that the FDA granted full approval to FILSPARI® (sparsentan) to slow ... read more »
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  Amneal and Shilpa Announce FDA Approval of BORUZU a an RTU Version of Bortezomib for Subcutaneous Administration
Amneal Pharmaceuticals, Inc. and Shilpa Medicare Limited announced FDA approval of BORUZU™, a new ... read more »
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  Vetter's European Clinical Site Successfully Completes First 100 Aseptic Fills
Vetter has successfully completed the first 100 clinical batches of liquid and lyophilized vials at ... read more »
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  FDA Clears Medigene’s IND Application for T Cell (TCR-T) Therapy for Multiple Solid Tumor Indications
Medigene AG announced that the FDA cleared the Company’s Investigational New Drug (IND) application ... read more »

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» QC Corner
QC Corner
  Enhanced Cleanroom Control: Modern Methods for Accurate Mold Detection
In this webinar, hear from Dr. Doug Botkin from Charles River Laboratories as he discusses Enhanced ... read more »

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» Cell and Gene Therapy Circuit
Cell and Gene Therapy Circuit
  Advances in Electroporation Technology: Cell & Gene Therapy Development Innovations from MaxCyte
Join Mike Auerbach, editor-in-chief at American Pharmaceutical Review and Debra Barberini, PhD, ... read more »

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» Infographic
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  Five Reasons Why Additive Manufacturing is Important and Beneficial for Drug Delivery
Download our latest infographic now for five reasons why additive manufacturing is important and beneficial for drug delivery. read more »
» Featured Articles
EVENT   Testing of High-Risk Drug Components for Diethylene Glycol and Ethylene Glycol
Ethylene Glycol and Diethylene Glycol contamination in liquid formulations pose significant safety risks. In recent years, multiple fatalities have ... read more »
EVENT   From Bitter to Better: How Capsules Improve Patient Acceptance of Medications
Understanding and enhancing patient acceptability towards medication regimens, particularly within the pharmaceutical sector, is paramount for ... read more »
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» Featured Video
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  On-Demand Webinar: How to Achieve Growth Based Microbial Contamination Detection in Less than 24 Hours
In this webinar, we will look together into real-world data that was generated during numerous validations of Growth Direct® Systems at various sites ... watch »
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  Live Webinar: Understanding the Invisible Threat: Mycoplasma Contamination in Cell Cultures
Join microbiology experts from Sartorius to learn about the causes, challenges, and solutions for maintaining Mycoplasma-free cell cultures. watch »

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» Featured Products
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  OMNIS NIR Analyzer
Metrohm USA The OMNIS NIR Analyzer series consists of modern, Swiss-made laboratory instruments for quality ... learn more »
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  BIOne Single-Use Fermentor
Distek, Inc. The BIOne Single-Use Fermentor (SUF) by Distek is ideal for numerous microbial fermentation ... learn more »
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  CHO-HCP ELISA Kit
Charles River Introducing the world’s first IgY based CHO-HCP ELISA kit specifically designed to close the ... learn more »

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» Featured Whitepaper
EVENT   eBook: Accelerating Process Chemistry
Are you juggling process data in ELNs, Excel, and other file-sharing systems? Luminata helps avoid the error-prone and time-consuming process of consolidating vast amounts of data. Learn how ... read more »
EVENT   Drivers of Implementation of Recombinant Technologies for Endotoxin Testing
This article explores the fundamentals of using recombinant Cascade Reagents (rCR), their analytical performance and equivalency to LAL reagents, current developments within the regulatory framework. read more »

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» More Products
AccuSizer SIS Liquid Particle Counter System Learn More
DSC 200 F3 Maia Differential Scanning Calorimeter Learn More
Mobius® Power MIX 100, 200, 500 L HDPE single-use mixing systems Learn More
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» Directory Categories
Pharmaceutical Tablet Press Machines Search More
Pharmaceutical Bioreactors and Fermentors Search More
Pharmaceutical Excipients Search More
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| Events
EVENT
  CPHI Worldwide 2024
Fiera Milano, Italy –  10/08/2024
With 62,000 attendees, CPHI Milan is the largest gathering in the pharma industry. We help you to discover, plan and connect with the community to ...
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EVENT
  PDA Pharmaceutical Microbiology Conference 2024
Washington, DC –  10/07/2024
Connect science and compliance at the 19th annual Pharmaceutical Microbiology Conference and navigate the crucial nexus between scientific advancement...
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