Critical quality attributes (CQA) are fundamental to regulatory compliance and typically include data on how the candidate interacts with target proteins, size, and purity. In addition, information on process related CQA such as protein integrity, homogeneity, presence of host cell proteins, and DNA is required. This poster booklet provides a snapshot on how different analytical technologies have been used to look into aspects related to the efficacy, stability, and safety of therapeutic candidates.
This article explains how maximizing the effectiveness of CO2 and yeast removal will assist in improving accuracy in total acidity measurements at every stage of the brewing process.
This report summarizes the results of an anonymous online survey conducted by The Analytical Scientist (Texere Publishing) on behalf of GE Healthcare. The intent was to learn more about the needs and preferences of individuals who were involved with high-performance liquid chromatography (HPLC) sample preparation.
A guide selecting the most relevant environmental parameters to study to retrieve the most useful information from collected samples.
This application note describes the production of adenovirus in HEK293 cells cultured in HyClone™ CDM4HEK293 culture medium.
Working within a high-intensity environment, any strategy to simplify workflows can both relieve pressure on analysts and support data quality, improving lab efficiency and throughput.
The costly proliferation of parts and components that often accompanies the pressure for product differentiation and customization can be controlled through multiple strategies. One of the easiest and most effective of these is to deploy EXALEAD Sourcing & Standardization Intelligence. By combining information sources with semantic information, these new products and applications go beyond the limits of conventional analytics solutions and deliver simple user experiences for decision makers.
Validating host cell protein ELISAs is an essential part of biologics development. But what makes these coverage assays so vital, and what could we improve? Read how this 2D DIBE approach combines the best of existing methods.
Roche (SIX: RO, ROG; OTCQX: RHHBY) today announced that it has received approval from the U.S. Food and Drug Administration (FDA) for the cobas Babesia test for use on the cobas 6800/8800 Systems for individual blood donation testing