Sartorius

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.

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.

Wednesday, July 14, 2021 at 11am EDT| 8am PDT| 4pm BST| 5pm CEST

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.

The Sartorius-developed software, the Extractables Simulator, allows flexible combination of multiple component extractables data and prediction to facilitate the use of single-use systems in critical processing operations.

This whitepaper discusses the potential implications on media management when implementing process intensification and explores strategies for overcoming this in both new and existing facilities.

Correct data is fundamental in a GxP quality system. This podcast will discuss what needs to be put in place to achieve data integrity and minimize the risk for an organization. We will discuss how to achieve data integrity and give real examples from FDA warning letters about the most frequent violations. To prevent violations, processes and systems should be designed to follow the ALCOA principles which will be explained in detail. We will review how a modern lab instrument can provide all the technical features which are needed to automate processes, ensuring that data integrity compliance issues are not created. As an example, we will present the functionalities of Cubis II, the 2nd generation premium laboratory balance from Sartorius. We will also discuss software applications for QC- or production-relevant applications like Tablet & Vial checker (Uniformity of dosage, USP chapter ), Loss on Drying (USP Chapter ), Standard preparation (USP Chapter ), Pharma Filling (Transfer of liquid products) or MYCAP CCX (Transfer of media and inoculum). The software applications safely guide operators through the workflow, automatically calculate the results and have conformity checks included.