Quality Assurance

INSIGHTS ON QUALITY ASSURANCE

Customer Story: Emergent BioSolutions Enhances Aseptic Filling Process
Upgrading outdated filling systems is essential for meeting future production demands and regulatory standards. Learn how one manufacturer modernized its approach to ensure compliance and efficiency.
Measuring ADC Positional Isomers Using Nonreduced CE-SDS And HIC
Combining HIC and nonreduced CE-SDS data enables estimation of ADC positional isomers. See how a system-of-equations approach offers practical structural insight without adding specialized assays.
Cryogenic Storage Of IV Bags For Cell And Gene Therapies
Cryogenic storage can compromise packaging integrity for cell and gene therapies. Learn how vacuum decay technology detects micro leaks and ensures product safety under extreme conditions.
Overcoming Challenges In Ophthalmic Formulations Through Polymer Selection
The growing demand for ophthalmic drugs is driven by aging populations and increased screen time, which contributes to rising eye conditions. Explore innovative solutions in ophthalmic drug development.

Biopharma Supply, Reimagined: Blarney, A Climate-Neutral Facility For Best-In-Class Filters
11/11/2025

Explore how a new, climate-neutral manufacturing facility strengthens biopharma supply chains. Understand the benefits of its advanced filtration technologies and commitment to environmental sustainability.
Robust, High-Throughput Automated Solution For Water Endotoxin Testing
4/21/2026

High-throughput water endotoxin testing doesn’t have to sacrifice consistency. Gain insight into how an automated workflow delivers reliable results, low variability, and strong control recovery.
Preparing For Future Changes To USP <87>: What Customers Should Know Today
7/16/2026

Upcoming updates to a key bioreactivity standard could impact qualification, supplier oversight, and testing. Learn how in vitro and risk-based approaches may shape future compliance.
Regulatory Compliance And Audits For Parenteral Manufacturing Precision
6/30/2025

CMOs play a critical role in regulatory compliance for parenteral manufacturing, using audits, quality systems, and proactive strategies to ensure product safety and patient well-being.
A Comparison Of Sizing And Quantification Performance
2/27/2026

Explore how automated electrophoretic analysis improves protein QC by delivering sharper sizing accuracy, stronger quantitative linearity, and greater consistency than conventional gel workflows.

Xcellerex™ X-Platform Bioreactors: A Next-Generation Single-Use Bioreactor System

Accelerate your gene therapy manufacturing with the Xcellerex™ X-platform – a next-generation single-use bioreactor system designed for viral vector workflows.
Aerosol Checkweigher

Ensure accurate aerosol can filling with this aerosol checkweigher, with a precision of ± 10 mg and a capability of up to 150 cans per minute.
Enhanced Opacity With Ideal Particle Properties

Titanium dioxide is extensively used in solid dosage forms as an opacifier and colorant. Due to regulatory developments and restrictions by authorities, formulators are increasingly interested in titanium dioxide-free solutions for both dietary supplements and medicinal products. Uniform colored and white coatings applied to tablets not only have an aesthetic function but also improve patient compliance.
The #1 Quality Management System (QMS) For Life Sciences

Unify your compliance and data ecosystem on a single platform. Automate training, manage document changes, and accelerate software validation seamlessly.
A Powerful Platform To Accelerate Operational Efficiency And Time-To-Market

This manufacturing platform optimizes fields such as digitizing work processes, quality management, and digital transformation in pharmaceutical companies. Looking to digitize? Read more here.