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.
Homogeneous environments are essential for successful bioprocesses. Using a benchtop model, we characterized system mixing dynamics and demonstrated the potential of power input and flow direction to effect system homogeneity.
Here, we demonstrate how you can reliably measure concentrations as low as 50 pg/mL of double-stranded DNA with our SpectraMax® Multi-Mode Microplate Readers and the Quant-iT Pico Green assay.
Here, Sartorius provides an overview of cell line development and the associated hurdles. We will then discuss potential solutions that form part of an effective risk-management strategy and improve productivity.
This document outlines references to 21 CFR Part 11 and EudraLex Annex 11 and how they apply to the implementation of SoftMax Pro GxP Data Acquisition and Analysis Software in regulated environments.
Combining high performance protein A capturing and a single polishing step on a salt-tolerant anion exchange resin, downstream costs were reduced by 45% in this Tosoh 2-step process for mAb purification.
Small batch applications may benefit from pre-sterilized ready-to-use primary packaging components supplied directly to the filling station as an alternative to operating a washing and sterilizing line.
