Search results for " CQA"
Article
A Closer Look at Affinity Ligands
Leached protein A is considered a CQA (critical quality attribute) to measure for with a release specification that must be met before the product can be released.Much progress has been made in recent…
Article
What is process development?
What is process development?
Biopharma process development comprises the activities that help you create a series of steps to produce a biomolecule – a monoclonal antibody (mAb), recomb…
Webcast
A route to deeper process understanding-Studying resin variability using a Process Characterization
Process robustness and success requires a thorough understanding of critical process parameters (CPP), critical material attributes (CMA), and sometimes interactions between these. Chromatography resi…
Article
On-Demand Webinar: A Route to Deeper Process Understanding—Studying Resin Variability Using a Process Characterization Kit
Process robustness and success requires a thorough understanding of critical process parameters (CPPs), critical material attributes (CMAs), and sometimes interactions between these. Chromatography …
Article
The Evolving Role of Starting Materials in Cell and Gene Therapy
The Evolving Role of Starting Materials in Cell and Gene Therapy
Accelerated approval pathways and growing demand for cell and gene therapies are putting pressure on providers of cellular starting m…
Article
Leveraging Computational Models of Glycosylation for Biopharma QA
Close collaboration between academic and industrial groups is vital to ensuring glycosylation models are fit for deployment.
By Ioscani Jiménez del Val
Good Studio/S…
Article
Sensitive and Reproducible SPR-Based Concentration and Ligand-Binding Analyses
Surface plasmon resonance (SPR) assays are used across the life cycle of a biopharmaceutical, from target identification, through CQA determination, development, and on-going quality control. This art…
Article
Process Development: What May Lie Ahead in 2018?
Article
Being Thorough When Transferring Technology
Communication and taking the time to develop the process are key to successful transfer and scale up of biologics.
By Susan Haigney
Editor's note: The following is an extended version of the…
Article
Going Small to Achieve Success on the Commercial Scale
Scale-down modeling is instrumental in supporting the development of downstream biopharma manufacturing processes.
By Cynthia A. Challener
Biopharmaceutical manufacturing involves a series o…