Whitepapers

Wyatt’s instruments and techniques constitute platform methods for effective product and process development, as well as quality control, of AAVs for gene therapy.

SEC-MALS identifies monomers, dimers, hexamers and higher aggregates of insulin to determine optimal formulation, storage and administration conditions.

Multi-angle light scattering, a powerful technology for biophysical characterization of biologics and LNPs, can also serve as an effective PAT tool to monitor product attributes during DSP.

SEC-MALS and CG-MALS characterize viral glycoprotein (vGP) self-association and the absolute stoichiometry and affinity of vGP:antibody interactions.

Watson-Marlow Fluid Technology Group (WMFTG), fluid path solutions provider of peristaltic pumps and single-use component, outlines the results of a study which makes comparisons between the semi volatiles extractables profile of post-cured and non post-cured samples of its Pumpsil platinum-cured silicone tubing.

This white paper presents the characterization of protein-DNA complexes using two complementary multi-angle light scattering techniques, SEC-MALS and CG-MALS.

Light scattering quantifies key attributes of lipid nanoparticle gene vectors such as payload, size, titer, and stability in formulation and physiological media.

This note demonstrates the use of DLS and online multi-angle light scattering with field-flow fractionation (FFF-MALS) for characterizing retrovial viral vectors.

Dynamic and static light scattering are applied to show that the choice of heating rate significantly impacts thermostability measurements of an IgG.

Measurement of the diffusion interaction parameter versus temperature by dynamic and static light scattering provides comprehensive analysis of protein stability.

Light obscuration analysis is standard, but size data alone is not adequate to ensure safe and effective drugs. FlowCam LO combines light obscuration and flow imaging in a single instrument.

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.

Using the Analytical Quality by Design (AQbD) approach, an Ultra High Performance Liquid Chromatography method was developed for the analysis of a mixture of metal chelating and non-chelating compounds. DryLab, Empower, and Waters systems were used to automate the method development process.

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.