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January 21, 2025

Newsletter Sponsor

Next Generation Sequencing for Cell and Gene Therapy

Biosafety testing is required for all biopharmaceuticals, including more advanced modalities like cell therapy, gene therapy, and mRNA products. With the unique nature of gene therapy, traditional GMP biosafety characterization and release methodologies may not be appropriate, and the use of alternative test methods are required. One primary alternate method being widely adopted across the industry is Next Generation Sequencing (NGS). Download this white paper to learn how NGS provides high quality, regulatory-accepted results to assure product safety and accelerate getting medicines to patients.

	Industry News

Bluejay Therapeutics Receives FDA Breakthrough Therapy Designation for Treatment of Chronic Hepatitis Delta
Bluejay Therapeutics announced that its lead product candidate brelovitug (also known as BJT-778) ... read more »

BioNet Wins BARDA Patch Forward Prize for Microneedle mRNA Vaccine Innovation
BioNet announced its selection as a Concept Stage winner in the United States Biomedical Advanced ... read more »

Health Canada Approves Long-Acting Injectable Treatment for Schizophrenia
Otsuka Pharmaceutical Canada Inc. and Lundbeck Canada Inc. announced that Health Canada has issued a... read more »

Amgen’s Lumakras® Approved for Colorectal Cancer
Amgen announced that the U.S. Food and Drug Administration (FDA) has approved LUMAKRAS® (sotorasib)... read more »

	QC Corner

Streamlining Environmental Monitoring: A CMO’s Success with 3P® ENTERPRISE
This case study explores Selkirk’s journey with 3P^® ENTERPRISE. Download now to learn how it ... read more »

	Cell and Gene Therapy Circuit

Cell and Gene Therapy Analytical Testing Considerations: Innovations from Thermo Fisher Scientific
Topics covered include key analytical testing considerations that are unique to cell and gene ... read more »

	Infographic

Pharmaceutical Sterility Testing
This infographic explores the drawbacks to traditional methods and the ways in which rapid testing methods are revolutionizing pharmaceutical ... read more »

	Featured Articles

		Executive Q&A: Biopharmaceuticals/ Biosimilars The market need is the main driver. Today, access to quality Biologics drugs is limited to a minority of the patients around the world. Increasing the... read more »

		Defining VHP Sterilization and Biodecontamination – Common Denominators and Differences VHP Applications History VHP has decades of successful use as a bio-decontamination process in the pharmaceutical industry and as a sterilization ... read more »

	Featured Video

On-Demand Webinar: Establishing a Facility Isolate Program to Support QC Testing and Validation
Join us for a comprehensive webinar on establishing a local facility isolate program based on environmental and process monitoring microflora trending... watch »

On-Demand Webinar: Overcoming Non-Conformance Challenges with Handheld Raman Devices for Raw Material ID
Join us to learn about Spatially Offset Raman Spectroscopy (SORS) and the Agilent Vaya Raman for identifying materials through both opaque and ... watch »

	Featured Products

MicroQuant™
ATCC MicroQuant™ by ATCC is a new product line of accurately quantitated microbial reference materials ... learn more »

Bettersizer 2600 Particle Size and Shape Analyzer (DIA+LD)
Bettersize Instruments The Bettersizer 2600 utilizes proven Laser Diffraction (LD) Technology to measure particle sizes ... learn more »

VACUUBRAND® VACUU-PURE® 10C Chemically Resistant Dry Screw Pump
BRANDTECH® Scientific The VACUU·PURE® 10C dry screw pump reliably delivers the benefits of oil-free vacuum technology in ... learn more »

	Featured Whitepaper

eBook: QC in Cell & Gene Therapy: Ensuring Safety, Efficacy, and Consistency
This eBook is a guide for QC labs in cell and gene therapy to ensure safety, efficacy, and consistency. Topics covered include a look at the future of QC micro labs, addressing the QC challenges in ... read more »

Ready-to-use Quantitative Microorganisms for Quality Control Testing
Ready-to-use quantified microbial standards enhance workflows and turnaround times in biopharmaceutical and cosmetic assays. Traditional methods require extensive efforts and revalidation. Our novel ... read more »

	More Products

Acconon Mixtures for Bioavailability and Emulsion Learn More
APW Active Ingredient Processing Workstation Learn More
Chemreveal LIBS Desktop Elemental Analyzer Learn More

	Directory Categories

Excipient Search Search More

Pharmaceutical HPLC Instruments Search More

Pharmaceutical Bioreactors and Fermentors Search More

	Events

INTERPHEX 2025
Javits Center – 04/01/2025
INTERPHEX is the leading global pharmaceutical and biotechnology event that fuses industry innovation with expert led conference. Taking place at the ... event details »

4th mRNA Analytical Development & Quality Control Summit
Boston, Massachusetts – 02/25/2025
Excitement for mRNA therapeutics continues as RNA technologies are awarded the Nobel Prize for the second year running. Yet, despite optimized ... event details »

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