The IT5's automation features allow for real-time communication and control of the instrument through secure OPC UA (Open Platform Communications united Architecture) communication, ensuring reliability and security for filter integrity testing.
In final filtration and filling operations, where maintaining sterility is critical to assuring drug safety for patients, sterilized single-use assemblies offer many advantages. This application note describes testing performed to assess volume loss in SURF assemblies and shows how both assembly design and filtration operations can be adapted to minimize volume and product loss in the system.
Owing to the sheer volume of data streaming from sensor profiles, anomalies observed during process monitoring in historical data are extremely difficult to search due to a lack of time series search tools. See how Bio4C™ ProcessPad’s new “Pattern Search” feature provides process engineers this ability to easily extract an anomaly profile from a time series for a time-range or within a batch.
In this tech note, we investigate the interactions between the spike glycoprotein binding with ACE2, binding with mAb/pAb to inhibit the interaction with ACE2, and spike glycoprotein and anti‑spike antibodies.
The Series 4000™ single-round filter housing line provides a range of pre-configured designs to meet all your process and filtration needs. It is available in T-Line and In-Line designs, with a wide range of tube sizes.
The Mobius® Chrom 20 system is a flexible, automated, single-use chromatography system that enables consistent and reliable separation and purification of mAbs, vaccines, plasma, and therapeutic proteins at clinical and process scales.
With a revolutionary three-dimensional macroporous hydrogel structure that provides a high density of binding sites and rapid mass transfer, Natrix® membranes deliver binding capacity that exceeds resin-based columns with fast flow rates. This combination of performance and speed enables scalable solutions for efficient purification of biologics.
The complexity of processes to manufacture cell and gene therapy medicinal products can cause confusion around definitions of raw materials, starting materials, process intermediates, drug substance and drug products. This document will discuss the definitions of the above process components.
Viral contamination is a risk for all biotechnology products. Establishing robust viral removal/inactivation steps mitigates the risk of adventitious and endogenous viral contamination and is essential for ensuring the safety of gene therapy products. Recent studies have shown that viral retentive filtration is one of the most robust steps in removing all types of viruses. In this study, we focused on the initial development process of the retroviral-retentive Viresolve® NFR filter.