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January 15, 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

Sen-Jam Pharmaceutical Announces Preliminary Results from Phase 2 Clinical Trials of SJP-002C for Upper Respiratory Infections/COVID-19
Sen-Jam Pharmaceutical announced the preliminary results from its recently completed Phase 2 ... read more »

Adimab Provides Update on Pipeline
Adimab announced that five therapeutic products containing molecules discovered or optimized by ... read more »

TNF Pharma Announces Positive Clinical Data Supporting Clinical Trial Expansion
TNF Pharmaceuticals, Inc. announced that it has achieved a key safety data milestone supporting ... read more »

Lilly Updates 2024 Revenue Guidance, Announces 2025 Revenue Guidance
Eli Lilly and Company announced that it expects 2024 full-year worldwide revenue to be approximately... 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

		Is the Timing of the Microbial Release Testing of Drug Products Important? The authors have become aware that regulators, especially during site inspections, are beginning to ask questions about whether pharmaceutical ... read more »

		Real Time Analytics Implementation in Continuous Manufacturing Process monitoring and control support the maintenance of a state of control during production and allow real-time evaluation of system performance. ... 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

OMNIS NIRS Analyzer: Metrohm
Metrohm USA The new OMNIS NIRS Analyzer is designed to redefine routine measurement. Whether you are measuring ... learn more »

Lab Incubator for Cell Culture
PHC The PHCbi Cell-IQ™ CO2 Laboratory Incubator MCO-170AICUVHLPA is a sophisticated cell culture ... 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 »

	Featured Whitepaper

Whitepaper: From LAL to rFC Assays - A More Sustainable Future for Endotoxin Testing
Sustainability is important to Lonza and the pharmaceutical and biomedical industries and our whitepaper highlights the importance and need for sustainable approaches. It also highlights the below ... read more »

PyroCell® MAT Rapid Systems - Quick Start Guide
For over 30 years, Lonza has supported QC testing for endotoxins and pyrogens. Our portfolio now includes two PyroCell® MAT Rapid Systems with optimized reagents for sensitive pyrogen detection. ... read more »

	More Products

AccuSizer Mini LE System Learn More
Zetasizer Nano ZS Size Analyzer Learn More
DSA 5000 M Density and Sound Velocity Meter Learn More

	Directory Categories

Excipient Search Search More

Pharmaceutical Bioreactors and Fermentors Search More

Cell Culture Media 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 »

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