Whitepapers

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.

Pharmacopoeias are collections of recognized and binding quality regulations that specify, among other things, test requirements and methods for the analysis of drugs. Both the European Pharmacopoeia (Ph. Eur.) and the United States Pharmacopeia (USP) contain specific chapters that deal with the use of laboratory balances. The chapters emphasize the criticality of weighing samples accurately in pharmaceutical analytical processes. The aim of this white paper is to present the testing requirements for laboratory balances as described in the relevant chapters of the pharmacopoeias and the associated certificates offered by Sartorius Service.

The purity of the solvents used, primarily that of water, is a decisive criterion for interference-free and reproducible analysis by liquid chromatography and for the sensitivity of this method, especially for applications in trace analysis. In a study, different sources of ultrapure water used as eluents were compared in high-performance liquid chromatography with diode-array detectors (HPLC-DAD) and mass spectrometry (MS) systems in various experiments

The Cubis® II balance series was designed for customizable modularity, which means the user can choose from many hardware and software options for thousands of different configurations. Choose from among 45 weighing modules, seven draft shields, two display and control units, and five software packages, including more than 60 software Apps.

In many laboratories, space is at a premium. Especially when centralized laboratory water systems are required to dispense pure and ultrapure water for your applications. To maximize your lab space capabilities, you shouldn’t have to adapt your water system to the laboratory. The system should adapt to your needs. In addition to being economical in terms of its footprint, flexibility in dispensing water is essential. Users need full control over quality parameters at the point of use and the ability to fill different sized containers at the same time across the lab. Sartorius will discuss an innovative and flexible lab water solution that addresses all of these requirements.

Water is a major component of all cell culture media and is, therefore, needed to prepare media, buffers, and additives, as well as to serve many ancillary functions, such as heating, cooling, cleaning and rinsing. Thus, water quality plays an important role in the outcome of cell culture experiments.

HPLC is an analytical procedure for separation, identification and quantification of substances using liquid chromatography. The beginnings of HPLC – High Pressure Liquid Chromatography – go back to the 60’s. Thanks to improved column materials and equipment, it has come to be known as High Performance Liquid Chromatography since the end of the 70’s.

In this Q&A, BioPharm International spoke with Sebastian Weber, product manager for lab weighing at Sartorius, about how to achieve data integrity, minimize risk and the potential for FDA violations, and how digital workflows can be supported by technology like the Cubis II lab balance.

An examination of Novel gene therapy development, understanding the biologic, the materials it contacts and intricacies of equipment, service offerings and partners to ensure effective cold-chain scale-up in cryogenic operations.

Whitepaper on the importance of a robust biopharmaceutical cold chain. Explore the logistical challenges involved in cold chain transport. Read about critical drivers for solution selection by biologic, developmental phase, and operations.

Screening studies of candidate proteins are critical in biopharmaceutical discovery. Preliminary assessment of the quality of the protein solutions by dynamic light scattering is imperative for reliable binding results.

The seasonal influenza vaccine market is projected to reach more than $4 Billion USD by the end of 2022. It is a safe assumption that as demand for seasonal influenza vaccines increases, so too with the demand for contract manufacturing organizations (CMOs) to support.

The Lucullus process information management system facilitates bioprocess development and optimization by centralizing data management and control of multiple BR1000 bioreactor systems that each employ dynamic PAT-driven glucose feeding