Search results for " biosimilars"
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.
Article
Biopharmaceutical Market in Asia: Q&A with Günter Jagschies, Strategic Customer Relations Leader, Cytiva
Competition, in particular in the biosimilars field, is fierce to say the least with around 100 companies looking at the same short list of about ten different drugs. The economics of manufacturing in…
Article
Tools and Solutions for Separation of Charged mAb Variants
A biosimilar is an almost identical version of an originator product. To attain regulatory approval, a comparable quality to the reference product in terms of efficacy, purity, and safety should be …
Article
Preclinical Evaluation of Product Related Impurities and Variants
Preclinical Evaluation of Product Related Impurities and Variants
The approaches for sample preparation of preclinical evaluation of safety and efficacy are addressed taking into consideration the s…