Quality Control

INSIGHTS ON QUALITY CONTROL

Detection And Quantification Of Amorphous Content In Materials
Complementary analytical techniques like DSC, MDSC, cRHp, DVS, and SolCal accurately quantify amorphous content in pharmaceuticals to ensure stability, compatibility, and efficiency.
Achieving Licensing For A Healthcare Solution
Facing strict regulations and tricky powders, a healthcare client sought an advanced filling solution. Learn how an expert collaboration led to licensed product, boosting precision and productivity.
Tackling Residual DNA Testing In Biotherapy Manufacturing
Controlling residual host cell DNA is critical for the safety and efficacy of biotherapeutics. Learn about robust, highly sensitive analytical methods for effective DNA clearance and process control.
Optimizing Contamination Control: Strategy Planning And Execution
A robust contamination control strategy using a plan-do-study-act framework ensures compliance, product quality, and operational efficiency in biopharmaceutical manufacturing facilities.

HPLC Autosampler Performance I: Challenging USP Methods
9/16/2024

In this study, the injection precision of an Alliance iS HPLC System was evaluated using four compendial HPLC methods from the USP with challenging method conditions and strict system suitability criteria.
Experience The Future Of Bioseparations
4/16/2024

Learn about an HPLC System designed to improve outcomes in QC labs with ease of use and simplicity at its core.
Innovative Technology For Developing, Scaling Peptide-Based Therapeutics
11/18/2024

Watch as experts walk through several technologies and case studies, focusing on liquid-phase peptide synthesis, crystallization, method development for impurity analysis, and more.
Mitigating Risks In Sterile Injectable Manufacturing: How CMOs Can Ensure Product Safety
7/23/2025

Sterile injectable manufacturing carries high risks. CMOs like Afton Scientific use rigorous quality systems, audits, and training to ensure patient safety, compliance, and product integrity.
A New Framework For Identifying Nitrosamine Risks And Derisking Products
6/18/2024

Examine a new methodology that holds significant promise for identifying APIs at risk for NDSRI formation, enabling manufacturers to prioritize risk mitigation strategies and ensure compliance.

R&D And Analytical Services

Our team of analytical experts provides experience, efficiency, and technical proficiency in the development/validation of analytical methodology and GMP testing support for your project.
Culture Media For Biological Indicators

Soybean Casein Digest Broth is the recommended media for use with Biological Indicators. The use of another media may detrimentally affect the outgrowth of spores.
A Full Spectrum Of Compliant, Ready-To-Use Mycoplasma Media With An Extended Shelf Life

As the only major supplier worldwide, we offer all three media to test for Mycoplasma according to EP 2.6.7 and USP 63 as both broth and agar plates. These ready-to-use Friis, Frey, and Hayflick culture media help to make the cumbersome compendial procedures of testing cell cultures, raw materials, intermediates, and final products for mycoplasmas easier.
FlexUP Technology Renewal Program: Keep Your Lab At The Forefront Of Science

Choose the ideal mix of services with our FlexUP Technology Renewal Program for continuous operation in your laboratory and across your enterprise.
Instrument For Accurate Filter Integrity Testing

The Palltronic Flowstar V integrity test instrument ensures accurate filter integrity testing with a further reduction in test time, full compliance with 21 CFR Part 11, advanced automation capabilities, and simplified network integration saving the user time while improving process efficiency.