In “Advances in Biopharmaceutical Analysis,” we highlight the latest developments in biopharmaceutical analysis, tackling topics such as advancing capillary column technologies for high-throughput microscale separations, using machine learning (ML)-based workflows for predicting oligonucleotide separation characteristics, and the changing regulatory landscape thanks to the integration of AI in biopharma for improving chromatographic peak integration.
Quantitative protein expression analysis is essential for advancing mRNA therapeutics, providing the data needed to confirm effective and targeted protein production. This article explores key assay development strategies, analytical challenges, and the application of advanced liquid chromatography-mass spectrometry (LC-MS) techniques to achieve precise and reproducible quantitation of proteins expressed from mRNA therapies.
This article demonstrates the suitability of ultrapure water from a Milli-Q® water system equipped with VOC-Pak® point-of-use cartridge for sensitive VOC analysis. This water is free of 58 VOCs evaluated, making it optimal for Purge and Trap GC-MS analysis of these compounds.
Nitrosamine contamination in pharmaceuticals has become a major regulatory concern due to their potent carcinogenicity, requiring ultra-trace-level detection to ensure patient safety. Advanced LC-MS/MS workflows provide the necessary sensitivity, selectivity, and robustness to accurately quantify nitrosamine drug substance-related impurities (NDSRIs), even within complex pharmaceutical matrices. Case studies with betahistine, orphenadrine, and chloropyramine demonstrate how streamlined LC-MS/MS strategies can reliably detect and confirm nitrosamine impurities well below regulatory thresholds.
Applying Analytical Quality by Design (AQbD) principles to impurity method development enables robust, science-based strategies for characterizing and controlling critical quality attributes in protein therapeutics. This webinar will present a case study on developing a fluorescence-based (FLR) method for quantifying Mannose-5 glycans, demonstrating how risk-based design and systematic evaluation of method parameters enhance reliability, reproducibility, and product understanding across the biopharmaceutical lifecycle.
This white paper covers the determination of nitrosamine impurities in pharmaceutical API’s and addresses issues associated with DMF and NDMA co-elution.
This case study highlights how a pharma company had a problem with low-to-medium task management and how Avantor Services was a solution deployed to meet the challenge with favorable results.
Every delay risks compromising critical samples, derailing progress, and forcing teams to start over. This video follows Ahmed, a scientist working in process development for drug production, as he navigates the challenges of sourcing ultra-high purity solvents, consumables, and chromatography columns for LC-MS analysis.
This article focuses on the important column selection decisions that are required for reversed-phase separations involving large biomolecules such as proteins.
This catalogue provides a comprehensive view of all our premium quality ACE columns for your HPLC and UHPLC needs.
This application note describes the separation of the 20 standard PFAS according to Directive (EU) 2020/2184 in only eight minutes.
High Throughput Quality Control (HTQC) is essential for laboratories analyzing dozens, hundreds, or even thousands of samples daily. This application note explores the critical elements necessary to achieve speed, reliability, and automation in high-throughput analysis. Find out how integrating advanced techniques—focused on increasing speed, sample throughput, and parallel processing—results in a robust system capable of improving your daily sample volume
n this application note, a USP monograph is modernized to a shorter column using 5 µm particles, which can be allowable under USP <621> as long as the N value is within the guidelines. By using highly efficient CORTECS 5 μm particles, this type of modernization is possible and reductions in solvent usage and run times are achieved
In this work the development of two key attributes of the 5um CORTECS Columns is examined. First column efficiency is compared across CORTECS and other solid-core 5 μm columns. Next scalability from sub-2 μm to 5 μm particles is examined between the CORTECS Column lines and competitive column lines. It was found that CORTECS columns have higher efficiency compared to other solid-core columns and that CORTECS particles are fully scalable.
Characterizing intact biotherapeutics such as monoclonal antibodies (mAbs) and antibody-drug conjugates (ADCs) under physiological conditions is essential for understanding their critical quality attributes. This paper will examine several advanced chromatographic and detection solutions—including SEC, HIC, affinity chromatography, MALS, and HRMS—to support structural analysis, molecular weight determination, and DAR quantification.
The first charged aerosol detector (CAD) was introduced in 2005. Nearly twenty years later, this near-universal detector has become an indispensable tool in the analytical chemist’s quantitative arsenal. This paper explores the CAD’s origin story, its adoption into everyday use by separation scientists, and its comparison to evaporative light scattering detector (ELSD). Technical highlights will include how parameters such as evaporation temperature influence application versatility, and how the power function impacts linearity and response behavior.
Ultrashort-chain PFAS (C1–C4) are important due to their widespread presence and here is an application solution for this analysis.
Step inside the world of forensic investigations with “From Sample to Verdict,” a LCGC International digital e-book sponsored by Shimadzu. “From Sample to Verdict” highlights recent advancements in analytical techniques for forensic science, particularly involving chromatography and mass spectrometry.
Slalom chromatography separates nucleic acids >3 kbp in <6 minutes using shear-based molecular stretching for high-resolution, gel-free analysis.
he United States Pharmacopeia (USP) has designations for all columns stationary phases used in the monograph methods. These designations outline the stationary phase type, i.e. fully porous or solid-core, and any ligand attachments, i.e. C18 or Phenyl to be used.1 However, beyond that no column specifics are given. With a multitude of columns that fit into the different designations, understanding that not all columns are the same is vital when selecting a stationary phase for a monograph method. This application note examines three columns that all fit into the L1 designation when analyzing paracetamol impurities. Selectivity differences between the columns are considered in relation to the impurities.
Explore how wide-pore SEC delivers sharp, reproducible separation of megadalton-sized DNA vectors and plasmids with minimal secondary interactions.
VUV’s diesel fuel application enables rapid, automated measurement of saturates, aromatics, PAHs, and FAMEs in a single GC–VUV run using ASTM D8368. This direct-injection method requires no sample prep or calibration curves, delivers class-based spectral validation, and provides accurate results in under 30 minutes
VUV’s GC–VUV platform with ASTM D8267 enables rapid, automated measurement of total, mono-, and diaromatic content in jet fuel with superior precision and reproducibility compared to FIA and HPLC. This direct-injection method requires no sample prep or calibration curves, delivers results in 14 minutes, and significantly lowers cost per analysis
VUV’s GC–VUV platform with ASTM D8071 enables fast, automated PIONA and multi-parameter gasoline analysis in a single run. It delivers superior precision and reproducibility compared to traditional methods, requires no sample prep or calibration curves, and consolidates multiple regulatory tests into one cost-efficient workflow
VUV detection extends HPLC sensitivity into 150–290 nm, enabling direct detection of underivatized amino acids with higher signal and linearity than PDA, eliminating the need for derivatization
Demonstrate reliable measurement of water at trace levels and beyond in acetonitrile using gas chromatography (GC) combined with the LUMA Multi-Channel Vacuum Ultraviolet (VUV) Absorbance detector. Additionally, we will demonstrate the ability of LUMA to detect water and multiple solvents in a single analysis.
HPLC columns are the critical component of any SEC/GPC experiments. Selecting the right column, compatible with your mobile phase, temperature range, particle size, and pore size, is essential for accurate results. Using this Column Selection Guide simplifies this process, helping you choose the ideal column for your analysis with confidence.
This article demonstrates the suitability of ultrapure water from a Milli-Q® water system equipped with VOC-Pak® point-of-use cartridge for sensitive VOC analysis. This water is free of 58 VOCs evaluated, making it optimal for Purge and Trap GC-MS analysis of these compounds.