INSIGHTS ON QUALITY CONTROL
-
Accelerate Biologics Product Release With Seamless Viral Testing
Explore viral safety testing for biologics, focusing on prevention, detection, and removal strategies, updated regulatory guidance, and common challenges in unprocessed bulk testing.
-
Vial Breakage During Lyophilization: Root Causes And Mitigation
Learn how controlling freezing rates, using specialized vials, and employing optimized stoppering techniques can reduce the risk of vial breakage during lyophilization and ensure high product quality.
-
Comparative Study On Secondary Contamination Risk
Accurate testing results are crucial for product safety. Explore the findings of a comparative study evaluating two different platforms for the membrane filtration of microorganisms in quality control.
-
Next-Gen Medium And Feeds System To Improve CHO Cell Line Productivity
Choose the right CHO medium and feed system to optimize your upstream processes and secure a seamless scaling up.
-
The Problem With Construction Quality10/21/2024
Data center construction quality management is inadequate, with issues traced to human error. A stronger focus on quality control and assurance is needed for success.
-
Water Activity And Primary Packaging For Oral Solid Dose Products7/10/2024
The draft of the general chapter USP<922> says water activity determination can be used to assess the level of protection of primary packaging for an oral solid dosage product over its entire shelf life.
-
Digitalizing Pharma Control Strategies: A Roadmap1/24/2025
Digitalizing control strategies in pharmaceutical manufacturing enhances product quality, compliance, and efficiency, leveraging data-driven approaches like QbD, and digital CPV for optimized processes.
-
Quantitative Determination Of Amorphous And Crystalline Drug In Polymer Microspheres12/30/2024
Biodegradable polymer microspheres control drug release through crystalline and amorphous properties, analyzed using DSC, MDSC, and TGA to determine composition and stability for precise delivery.
-
Mitigating Risks In Sterile Injectable Manufacturing: How CMOs Can Ensure Product Safety7/23/2025
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.
QUALITY CONTROL SOLUTIONS
-
Flexible, reliable control and bioreactor systems for laboratory applications
Thermo Scientific™ HyPerforma™ bioprocess control systems are designed to optimize your process from the laboratory bench to full cGMP manufacturing. Our innovative control platform combines a flexible operating system with scalable, modular hardware, novel single-use sensors, and state-of-the-art bioreactors for strategic and streamlined bioprocess control.
HyPerforma benchtop solutions offer robust management of both cell culture and fermentation processes. The open architecture provides process flexibility, and dedicated hardware control allows for expansion. Thermo Scientific™ TruBio™ software is designed to support easy process control and scaling.
-
Developed for plasma protein binding determination and free fraction analyses, the Supel™ BioSPME 96-Pin Devices greatly improve upon the speed and simplicity of current sample preparation techniques.
-
Realize the full potential of your cell therapy research. Experience end-to-end support to overcome developmental complexities, helping you to efficiently and safely commercialize your groundbreaking treatments.
-
Learn how the right partner can ensure that your facilities maintain cGMP-compliance and help establish the correct testing program and parameters based on your needs.
-
Bioburden testing and microbial limit testing are quality control tests for determining the total number of viable microorganisms of pharmaceutical and medical products. Thanks to its many cleverly designed features, the Milliflex Oasis® is a particularly productive and reliable membrane filtration method for performing bioburden testing in accordance with USP, EP, and JP recommendations, ensuring that patients can call upon microbially safe products.