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November 14, 2024

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Free Webinar: Risk-Based Development to Support Process Qualification for SDD
Sponsored by Lonza Small Molecules
This session delves into a risk-based approach for supporting process qualification of amorphous solid dispersions produced by spray drying. Our expert speakers discuss the integration of process design and qualification into the broader process validation strategy, emphasizing how small-scale experiments can optimize drug substance usage and mitigate risks during the qualification stage. We also cover critical elements of product design, illustrating how a risk-based approach can create robust processes with inherent manufacturing flexibility.

	Industry News

FDA Approves Gene Therapy for Treatment of Aromatic L-amino Acid Decarboxylase Deficiency
The FDA approved Kebilidi (eladocagene exuparvovec-tneq), an adeno-associated virus vector-based ... read more »

FDA Authorizes AI-Driven MRI Solution for Safer Alzheimer's Treatment
The FDA granted icometrix clearance for icobrain aria, an AI software approved for detecting, ... read more »

Orsini to Distribute Vertex’s CASGEVY® Gene-Editing Therapy
Orsini has been chosen by Vertex Pharmaceuticals Incorporated to dispense gene-editing therapy ... read more »

Merck Licenses LM-299, An Investigational Anti-PD-1/VEGF Bispecific Antibody from LaNova Medicines
Merck and LaNova Medicines Ltd. announced an exclusive global license to develop, manufacture and ... read more »

	QC Corner

Lab Balances in QC Labs
Watch this video to learn more about the solutions offered by Sartorius that will help you achieve ... read more »

	Cell and Gene Therapy Circuit

eBook: Mastering Advanced Cell Cultures with Superior Media and Live-Cell Insights
This eBook explores the vital role of media in reliable, reproducible cell maintenance, including ... 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

		From Laboratory to Market: Advanced Analytical Approaches in Biopharma The drug development landscape has undergone a massive transformation in recent years, driven by advancements in bioprocessing and the rise of ... read more »

		Lyophilization Technology for Improving Stability of Small and Large Molecules The instability of drugs constitutes a major barrier in the commercial development and manufacture of pharmaceutical products. Lyophilization, or ... read more »

	Featured Video

Moving Towards Sustainable BET Testing
Download this video to learn how you can meet the demands of supply security while protecting a natural resource. watch »

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 »

	Featured Products

BioTrak® Real-Time Viable Particle Counter
TSI Incorporated Isolators are designed to keep operators out and sterile product safe. Nevertheless, traditional ... 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 »

Early Development to Commercial Supply
Serán BioScience, LLC Serán’s New Commercial Manufacturing Facility will enable end-to-end support for your drug ... learn more »

	Featured Whitepaper

eBook: Mastering Advanced Cell Cultures with Superior Media and Live-Cell Insights
This eBook explores the vital role of media in reliable, reproducible cell maintenance, including the challenges of developing 3D cell models. read more »

Live-Cell Analysis for Quantification of Organoid Growth Dynamics Using Sartorius RUO Growth Factors and Cytokines
This application note investigates the efficacy of recombinant growth factors in enhancing organoid expansion and allowing researchers meticulous control over culture conditions. read more »

	More Products

AccuSizer SIS Liquid Particle Counter System Learn More
BioFlo® 320 Bioprocess Control Station Learn More
Cary 3500 Flexible UV-Vis Spectrophotometer Learn More

	Directory Categories

Excipient Search Search More

Pharmaceutical and Bioprocess Filtration Systems Search More

Pharmaceutical HPLC Instruments Search More

	Events

3rd Annual PAT & Real Time Quality Summit
Philadelphia, PA – 12/11/2024
With drug developers and manufacturers facing closer scrutiny on product quality than ever before, it’s time to make the most of evolving process ... event details »

Eastern Analytical Symposium and Exposition (EAS) 2024
Crowne Plaza Princeton Conference Center – 11/18/2024
The Eastern Analytical Symposium and Exposition (EAS) is an annual gathering of scientists and students of the analytical and allied sciences. It ... event details »

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