Search results for " hcp"
Article
Challenging Host Cell Protein Assays for Improved Risk Mitigation
We will address how to challenge your assays early to ensure accurate measurements, build confidence, and reduce the risk of unexpected HCP levels.
Article
Host cell protein quantitation using ELISA
However, it’s challenging to detect HCP, and this step can be time-consuming.
This application note shows how using the sensitive HCPQuant™ CHO ELISA kit (Cytiva) and automating wash steps using Aqu…
Article
Re-use of Protein A Resin: Fouling and Economics
Thus, Protein A is considered to be the most crucial step in the purification process and a major contributor towards achieving the stringent purity levels expected of biotech therapeutics with HCPs r…
Article
Evolution of the Monoclonal Antibody Purification Platform
Though it may not be as efficient as Protein A in terms of selectivity of HCP, it can be used in combination with effective HCP precipitation step. Additionally, to gain similar HCP clearance compared…
Article
The Development and Application of a Monoclonal Antibody Purification Platform
After cation exchange, diafiltration was performed to prepare the product for anion exchange chromatography in flow through mode, in which impurities such as DNA and some HCPs were captured on the res…
Article
Current Trends in Host Cell Protein Detection for Biologics Manufacturing
Commonly accepted HCP analytical methods, the challenges of HCP assay, and recommendations on what can easily be accomplished in-house and when it may be better to outsource.
Read more here…
Poster
Comparison of Three Different Screening Techniques for Predicting Step Elution Conditions for a Cation Exchanger
Selected conditions were applied in column step elution experiments and antibody yield, pool volume and reduction of HCP was compared.
Click below to download the poster.
Article
Moving PAT from Concept to Reality
“Trace metals, glucose, lactate, pH, DO, amino acid content, glycosylation profiles, and HCPs must be measured to monitor the process and enable feedback/feedforward control to optimize yield (in-line…
Article
Impurity Testing of Biologic Drug Products
For example, ELISA is the gold standard and work horse for host cell protein measurement, but it only measures the total HCP and can’t give detailed information on the level of each individual host ce…
Article
Comparing Protein A Resins for Monoclonal Antibody Purification
A prototype Protein A resin is evaluated for purification performance, reusability, and cost performance.
With greater economic pressure on monoclonal antibody (mAb) production for therapeutic …