Search results for " biosimilars" 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 biosim…
Article
Process Chromatography: Continuous Optimization
“For biosimilars, it is necessary to produce a comparable pattern of protein variants. That requires removal of closely related byproducts in proteins, such as charge or glycosylation variants,” Bulpi…
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
Apr 06, 2015
By Anurag S. Rathore, Sumit K. Singh
BioPharm International
The ever increasing demand of biotherapeutics, together with the pressure to contain healthcare costs have motiva…
Article
A Q&A With Dr. Anurag Rathore About the Future of QbD, Part I
This two-part Q&A series with Anurag Rathore, PhD, Professor, Department of Chemical Engineering, Indian Institute of Technology, Delhi, reveals the evolution of QbD, the types of companies implemen…
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.