Search results for " monoclonal"
Poster
Fast Trak Services: a collaborative project to accelerate downstream biosimilar process development
The molecule exhibits monoclonal antibody (mAb) behavior, however, with a challenging glycosylation profile and complex tertiary and quaternary structures. Consequently, low product recovery and pur…
Article
Fusion Proteins Pose Manufacturability Challenges
“Overall,” he adds, “a fusion protein will often have liabilities that will need to be addressed by more process development than would be typically needed for monoclonal antibodies (mABs), which are …
Article
Being Thorough When Transferring Technology
BioPharm: Are there specific challenges for the tech transfer of antibody-drug conjugates (ADCs)? Monoclonal antibodies? Cell therapies?
Moscariello and Young (CMC Biologics): The major challenges…
Article
Downstream Processing for Cell-Based Therapies
Unlike the traditional manufacture of monoclonal antibodies (mAbs) and other biologics, the production and processing of cellular material forms the basis of the product for CGTs (1). As such, manufac…
Article
Mechanistic Modeling of Preparative Ion-Exchange Chromatography
In the following section, a case study of of a monoclonal antibody (mAb) in an IEC model is presented.
Mechanistic modeling for development of an ion-exchange chromatography step to purify m…
Article
HTPD: Optimizing a mAb Chromatography Polishing Step
Development of robust purification processes requires significant time and resources. In addition, steadily increasing demands from regulatory authorities for better understanding and control of man…
Article
Cost Considerations Drive Lean Technology in Biopharmaceutical Manufacturing
By Catherine Shaffer
Four biosimilars have been approved for the market by FDA as of February 2017, and more are in the pipeline. Now that biosimilars are here to stay, manufacturers are devel…
Article
Reconciling Sensor Communication Gaps
The desirability of platform purification, best exemplified in monoclonal antibody (mAb) downstream processing, simultaneously creates and reduces the need for extensive downstream monitoring. Platfor…
Poster
Effects of feeding strategy on CHO cell performance in fed-batch cultures
This work demonstrates the development of a fed-batch process for a Chinese hamster ovary (CHO) cell line producing a monoclonal antibody (mAb). The results emphasize the importance of an appropriate …
Article
Biosimilars to Drive Modern Manufacturing Approaches
Reliable, high-quality products require innovative analytics and production.
By Jill Wechsler
As more biosimilars gain market approval in the United States, and manufacturers launch addition…