Whitepapers

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. 

Dynamic and static light scattering are applied to test the effect of ramp rate on thermostability measurements of an IgG. The choice of heating rate significantly impacts results.

This application demonstrates excellent performance in method development for the analysis of raw materials for oligonucleotide synthesis using a biocompatible UHPLC.

The coupling of FPLC to MALS not only detects but also quantitatively determines the absolute molecular weight and size of each species, including the targeted molecules, impurities, and its aggregates.

Comparison of HPLC and Octet® system to determine MAb concentration in a complex feedstock using mAbs breakthrough as the analyte while monitoring method accuracy, precision, dynamic range, LoQ and cost per sample.