Whitepapers

In this White Paper, Sartorius outlines the challenges of scaling a bioprocess and presents solutions to maintain control over critical quality attributes.

This paper explores a Quality by Design (QbD) approach to applying Artificial Intelligence (AI) in pharma manufacturing.

Technical proficiency in downstream processes is critical for successful drug substance manufacturing. Utilizing a CDMO’s experience and expertise in developing appropriate processes for your molecule can help achieve program goals.

This application note describes multi-attribute analysis of monoclonal antibodies. The analyzer combines multidimensional chromatographic multimethod analysis options.

See how implementing an enhanced approach, like Analytical Quality by Design (AQbD), for method development can help you to access high quality, reportable data.

This case study determines the adoption of Waters ACQUITY UPLC and ACQUITY QDa™ technology in contributing to the success of independent pharmaceutical service provider Chromicent, by providing more information faster and earlier in the method development process.

In this work, an UltraPerformance Liquid Chromatography method was developed for the analysis of Valsartan and a mixture of six genotoxic impurities using the Analytical Quality by Design (AQbD) approach. Findings indicated that using the AQbD approach and automated software helps gain a deep knowledge about the method and as a result, increases method robustness and reproducibility.

Learn how Hovione, a global CDMO, has determined that the combination of Waters instrumentation and AQbD is a powerful strategy for method development that leads to better, faster, greener analytical methods, enables resource optimization, and more.

Analytical method performance is critical to ensure the quality, safety, and efficacy of pharmaceutical products. Two of the most commonly used ones are One Factor at a Time (OFAT) and Analytical Quality by Design (AQbD). In this work, a robust method for budesonide, formoterol, and related compounds was developed using a Quality by Design approach on an ACQUITY UPLC H-Class PLUS System running Empower 3 and Fusion Software.

Chromatographic methods developed to analyze pharmaceutical compounds must distinguish low-level impurities before they reach alert/action levels. Parameters such as retention, peak shape, and sensitivity are very important to successfully accomplish this. Read this app note to learn more about MaxPeak Premier Technology.

This white paper describes the use of Empower™ 3 Control Charts to facilitate the continued procedure performance verification stage of the analytical procedure lifecycle approach.

Modern approaches to analytical procedure development such as Analytical Quality-by-Design (AQbD) focus on the reliability and accuracy of the final result, encouraging Analytical Developers to understand how aspects of sampling, storage, sample preparation, personnel training, instrument parameters, and data handling might affect result reliability. Find out more about AQbD and the best tools to design and develop fit-for-purpose methods.

This infographic demonstrates about Waters’ products, support, training, and expertise for a seamless Analytical Quality by Design (AQbD) implementation in your lab.

Replace ELISA and HPLC with Octet® systems for quantitation of antibodies and recombinant therapeutic proteins. Accurate and fast assays are also easy to develop and transfer to QC and manufacturing.

The 1290 Infinity II Bio LC including High-Speed Pump, with its iron‑free flow path, is optimally suited for the conditions used in biochromatography.

This paper describes the requirements for electronic records and electronic signatures for regulated pharmaceutical organizations.

Analysis of antibody drug conjugates using hydrophobic interaction chromatography with the Agilent 1290 Infinity II Bio LC System

The Agilent Bio-Monolith rProtein A (recombinant protein A) analytical column is the latest addition to the Bio-Monolith and affinity chromatography family.

Superior resolution in size exclusion chromatography (SEC) protein separation made possible by the Agilent 1290 Infinity II Bio LC System.

The Agilent 1290 Infinity II Bio LC System is the new platform for UV and MS-based primary structure and PTMs analysis of mAbs.

This study demonstrates how to increase sample throughput for glycan characterization workflows using the Agilent AssayMAP Bravo liquid handling platform.

Peptide-mapping analysis shows excellent performance and high method compatibility compared to the Agilent 1290 Infinity II LC System.