Bio/Pharmaceutical Analysis, HPLC/UHPLC

Instrumentation advancements over the past 30 years have certainly enabled greater efficiency in pharma development and analysis despite slow adoption by the industry.

The LenS3 Multi-Angle Light Scattering (MALS) detector, presented at Pittcon 2019 in Philadelphia, PA, uses a new approach for measuring molecular weight and radius of gyration of synthetic polymers, polysaccharides, proteins, and biopolymers.

HPLC coupled with charged aerosol detection is a suitable analytical technique to quantitate and characterize polysorbate-80 in therapeutic products; allowing quality assessment of raw material, content confirmation during manufacturing, and monitoring product stability.

Investigation of peak purity failure during HPLC method validation led to discovery of a co-eluting impurity under the main peak. Spectral analysis, including three-dimensional modelling, was used to characterize the peak, leading to the development of a new HPLC method for analysing impurity content.

Leveraging vast quantities of analytical data requires digitalization and platform integration.

The company has built a fit-for-purpose liquid chromatography–mass spectrometry (LC–MS) system to streamline analytical monitoring tests for biopharmaceuticals.

By adapting techniques from other sciences-and exploring better tools for biologics drug development-researchers are addressing challenges of protein characterization.

Integration of new modeling and analytical tools with flow chemistry are notable trends.

As it investigates the root cause of an impurity discovered in valsartan, FDA extends its studies to APIs with similar synthesis processes.

Flush solutions for liquid chromatography mass spectrometry (LC-MS) systems and ultrapure solvents for ultra-high-performance LC-MS systems from Thermo Fisher Scientific can minimize interference and maximize lab instrument uptime.

The company’s next-generation ultraperformance liquid chromatography platform is designed to meet the evolving laboratory requirements for chromatographic performance.

Access to multiple analytical techniques is essential for fully characterizing complex protein formulations.

New, user-friendly analytical systems provide high-throughput comprehensive characterization and quantitation of small and large molecules.

New technologies, such as NIR and Raman, enable online measurements of blending and content uniformity in the production of solid dosage forms.

Experts share insights on the various methods used for purity and impurity analysis of therapeutic proteins.

The company added new products to its InfinityLab LC Series which will be showcased at HPLC 2017 in Prague.

This paper describes a unique Prep-rP-HPLC technique that uses a C-18/C-8 derivatized silica coated with a hydrophobic quaternary ammonium salt or quaternary phosphonium salt that acts as an additional/surrogate stationary phase (AsP/ssP).

The Nexera-i MT from Shimadzu incorporates two flow lines, which allow for both UHPLC and HPLC analysis.

Process analytical technology paved the way for continuous manufacturing.

W.R. Grace & Co. will sell its chromatography product lines, which includes chromatography instruments, columns, and other related products.

Today’s analytical laboratory equipment reflects the realities of downsizing, outsourcing, and the need for speed.

Shimadzu’s Nexera MP UHPLC Front End system for LC/MS is perfect for LC/MS analysis conducted in pharmacokinetics and synthesis stages in drug detection processes. read more

Shimadzu has introduced the i-series of integrated HPLC and UHPLC systems. The analyzers meet the needs of any analytical environment with high speed, outstanding performance, maintainability and economic efficiency.

Shimadzu’s Nexera Method Scouting system provides an outstanding platform for efficient HPLC method development and implementation. It is based on the Nexera X2 next-generation ultra-high performance liquid chromatograph, an all-round LC system for ultra-high-speed analysis.

Shimadzu’s Nexera MP UHPLC Front End system for LC/MS is perfect for LC/MS analysis conducted in pharmacokinetics and synthesis stages in drug detection processes.

Shimadzu’s Nexera Method Scouting system provides an outstanding platform for efficient HPLC method development and implementation. It is based on the Nexera X2 next-generation ultra-high performance liquid chromatograph, an all-round LC system for ultra-high-speed analysis.