Search results for " biosimilarity"
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
Process Chromatography: Continuous Optimization
Improved resin chemistries and customized separation solutions are enabling more efficient separations.
By Cynthia A. Challener
Cell-culture and fermentation are high-…
Article
Innovative Therapies Require Modern Manufacturing Systems
FDA and industry see progress and challenges in bringing cutting-edge medicines to patients.
By Jill Wechsler
FDA set a 19-year record in 2015 in approving more new drugs and biologics, and …
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
The FDA talks about the changing scope of regulatory science.
Regulatory science underpins innovation and practices in drug manufacturing. The most common definition of r…
Article
Preparing for the Future Visions and Insights for Biomanufacturing
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The biopharmaceutical industry has a reputation of being averse to change. Yet, new market dynamics, such as growing competition from biosimilars and niche drugs targe…
Article
Biopharmaceutical Market in Asia: Q&A with Günter Jagschies, Strategic Customer Relations Leader, Cytiva
This week, the Process Development Forum talks with Günter Jagschies, Strategic Customer Relations Leader, Cytiva, about the biopharmaceutical market in Asia.
The Asian market is most often s…
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…