Waters Corporation

Articles by Waters Corporation

CDMS is reshaping the characterization of complex biotherapeutics by enabling precise analysis of large, heterogeneous biomolecular complexes and gene therapy vectors. This article explores how CDMS enhances resolution in quality assessments across biotherapeutic development and structural biology research—surpassing the capabilities of conventional analytical techniques.

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.

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.

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.

Frontage laboratories wanted to improve the efficiency and quality of their operations and invest in ways to streamline their workflows. They implemented Waters NuGenesis™ Lab Management System (LMS) to progress their digital transformation journey and combine synergistic data, workflow, and sample management capabilities to support the entire product lifecycle from discovery through manufacturing.

Shandong Loncom Pharmaceutical Co. implemented NuGenesis LMS to help with generation of reliable and compliant production data, address electronic data management challenges, achieve accurate and efficient sample tracking, and manage increasing amounts of data. Learn more about how NuGenesis™ LMS enables labs to collect, record, and analyze experimental data for improved operational efficiency and data accuracy.

Level up your Empower data with in-depth dashboards and powerful custom data analytics. waters_connect Data Intelligence Software provides real-time, in-depth dashboards and powerful, purpose-built analytics on your Empower Software data to reduce risk, save money, improve productivity, and accelerate time- to-market.

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.

HPLC method development of structurally similar components is an arduous task to undertake. Understanding the principles of liquid chromatography and applying them in a structured, streamlined approach not only speeds up the method development process but also provides traceability for the activity in an easy-to-follow format. Having a structured protocol for method development also allows novice users to develop methods independently, without the oversight of expert chromatographers. This app note shows fast method development using a structured protocol called the systematic screening protocol. The protocol used to develop the method relies on MaxPeak™ High-Performance Surfaces (HPS) technology, featured in MaxPeak Premier Columns, to mitigate any non-specific adsorption (NSA) seen between the column and the analytes. Employing this column technology, along with the systematic screening protocol, a method was developed which provides good peak shape and complete separation of all eight dyes.