Search results for "biosimilar" in Articles / App Notes
Article
Developing a HIC polishing step for removal of mAb aggregates
This article describes the development of a flow-through (FT) polishing step using hydrophobic interaction chromatography (HIC) to remove mAb aggregates.
It includes:
- The use of HTPD plate…
Article
Get to know: mAb variants - eLearning
The diversity of antibody variants in the biotherapeutics pipeline are increasing with a growing interest for molecules like antibody fragments and bispecific antibodies (bsAbs). Cytiva has pu…
Article
The Future of Biopharma
When it comes to meeting unmet needs, biosimilars have a huge role to play, as they introduce competition to the market that can help to bring down the cost of expensive biopharmaceuticals. In the sec…
Article
The Outlook for CMO Outsourcing in 2019
…is expected to increase in coming years, as new classes of products receive approvals, particularly biosimilars and cellular and gene therapies. In the next five years, the number of approved biosimi…
Article
Process Chromatography: Continuous Optimization
Biosimilars and other challenges
The increased trend toward the development of two-step chromatography processes and higher protein doses is requiring more performance from chromatography products, …
Article
Innovative Therapies Require Modern Manufacturing Systems
More biosimilars are poised to come to market in 2016 following FDA approval of the first such therapy in 2015. At the same time, though, the development of such innovative and targeted therapies heig…
Article
Use of Multivariate Data Analysis in Bioprocessing
Establishing comparability forms an integral and crucial aspect of biosimilar development. In fact, the underlying essence of biosimilar development is that if the manufacturer is able to demonstrate …
Article
A Q&A With Dr. Anurag Rathore About the Future of QbD, Part I
Even biosimilar manufacturers based outside North America and Europe are also implementing QbD. But every company is in the process of trying to figure out better (as in more efficient with respect to…
Article
A Look Ahead at BioPharma Manufacturing and Regulation
ANALYTICAL METHODS
BioPharm: Priority 3 in the strategic plan also calls for developing new analytical methods, including those to determine similarity between reference products and biosimilars…
Article
Preparing for the Future Visions and Insights for Biomanufacturing
Yet, new market dynamics, such as growing competition from biosimilars and niche drugs targeting smaller patient populations, are reshaping how drugs are produced and sold.