Search results for " comparability"
Article
The Outlook for CMO Outsourcing in 2019
By Eric Langer and Ronald A. Rader
Biopharmaceutical industry-related indicators and trends are supporting continued incremental increases in outsourcing of pre- and commercial AP…
Article
Scaling Up Novel Therapies
Scaling Up Novel Therapies
Platform processes have improved monoclonal antibody scale-up. Can they do the same for personalized therapies?
By Agnes S…
Article
Recent Advances in the Use of Exoglycosidases to Improve Structural Profiling of N-glycans from Biologic Drugs
Recent Advances in the Use of Exoglycosidases to Improve Structural Profiling of N-glycans from Biologic Drugs
Analytical exoglycosidases are transitioning from being largely academic tools to being s…
Article
Process Economy Simulations on a Protein A Capture Step
MabSelect PrismA is a next‐generation protein A chromatography resin that offers significantly enhanced alkaline stability and capacity compared with its predecessor products. This application note …
Article
CoAs Help Secure the Supply Chain
CoAs Help Secure the Supply Chain
Certificates of analysis can be used to monitor the reliability of products and their suppliers.
By Susan J. Schniepp, distinguished fellow at…
Article
Making the Move to Continuous Chromatography
Making the Move to Continuous Chromatography
Early adopters are benefiting from lower costs and increased productivity.
By Cynthia A. Challener
Tashatuvango/Shu…
Article
Manufacturing Standards Key to Advancing Cellular and Gene Therapies
Anne Plant, division chief for biosystems and biomaterials at NIST, observed that comparability assessment is key to determining that changes in a production process do not undermine quality and safet…
Article
Development and Future of Protein A Chromatography Technology: Q&A with Jonathan Royce, Business Leader Chromatography Resins, Cytiva
This week Process Development Forum talks about Protein A with Jonathan Royce, business leader for Cytiva chromatography resins.
mAb purification platforms are very well established, and …
Article
Impact of Media Components on CQAs of Monoclonal Antibodies
The authors review how media components modulate the quality of monoclonal antibody products.
By Anurag Rathore, Rajinder Kaur, Dipankar Borgayari
Recombinant protein products have…
Article
Evaluating E&L Studies for Single-Use Systems
Extraction studies demonstrate approaches for evaluating single-use bio-pharmaceutical manufacturing materials.
By Irene Cecchini, Daniele Mastroianni, Silvia Rocchi, Gabriella Angiuoni
Biop…