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October 03, 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.

	Industry News

FDA Clarifies Policies for Compounders as National GLP-1 Supply Begins to Stabilize
The FDA determined the shortage of tirzepatide injection, a glucagon-like peptide 1 (GLP-1) ... read more »

Legend Biotech to Establish Cell Therapy Research and Development Facility in Philadelphia, PA
Legend Biotech Corporation is establishing a new, state-of-the-art research and development (R&D) ... read more »

Eton Pharmaceuticals, Inc to Acquire Increlex®
Eton Pharmaceuticals, Inc. has entered into an asset purchase agreement to acquire Increlex® (... read more »

Charles River and Lundbeck to Use AI-Powered Logica® to Advance the Discovery of Novel Drugs for Neurological Disease
Charles River Laboratories International, Inc. announced an agreement with H. Lundbeck A/S to ... read more »

	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 »

	Infographic

Revolutionizing Bioburden Testing
Download this infographic to learn ten benefits of the Sievers Soleil Rapid Bioburden Analyzer, including comprehensive monitoring, rapid time to ... read more »

	Featured Articles

		The Many Ways How Digitalization Is Improving Sterility Testing Do you know what percentage of citations in post-inspection, FDA Warning Letters relate to documentation issues and written procedures? The answer is ... read more »

		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 »

	Featured Video

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 »

Ensuring Regulatory Compliance in Cell Therapies from Lab to Bedside
To streamline regulatory submission and smooth the transition from R&D toward manufacturing, it is crucial to maintain comprehensive and precise ... watch »

	Featured Products

QUALIS UV Laser Printer
Qualicaps As a pioneer in capsule and tablet manufacturing, Qualicaps has accumulated a wealth of expertise ... learn more »

JCF-100 Fully Automatic Auger Capsule Filling Machine
Qualicaps As a pioneer in capsule manufacturing, Qualicaps has accumulated a wealth of know-how and ... learn more »

BIOne Single-Use Fermentor
Distek, Inc. The BIOne Single-Use Fermentor (SUF) by Distek is ideal for numerous microbial fermentation ... learn more »

	Featured Whitepaper

eBook: Principles of Bioburden Testing
This eBook covers automation in bioburden testing, aligning automated bioburden testing and regulatory policy, the impact of USP <1117>, and more. read more »

eBook: Navigating Today and Tomorrow’s Sterility Testing Landscape
This eBook aims to provide a comprehensive overview of the sterility testing landscape, exploring both the present and the future. read more »

	More Products

Antaris Target NIR Blend Analyzer Learn More
B-395 Pro Encapsulator Learn More
Cary 6000i UV-Vis-NIR Spectrophotometer Learn More

	Directory Categories

Excipient Search Search More

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	Events

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 ... event details »

PDA Universe of Pre-Filled Syringes and Injection Devices Conference 2024
Phoenix, AZ – 10/22/2024
Learn about groundbreaking innovation in injectable drug delivery at the 21st edition of this popular conference! The largest event on pre-filled ... event details »

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