Feb 09, 2016
There are no clinically meaningful differences between Celltrion’s CT-P13 and Remicade, according to an FDA briefing released ahead of the formal panel meeting.
Feb 04, 2016
Although switching has occurred in European markets for some biosimilars, most biosimilar manufacturers will focus on securing new users, according to Merck.
Feb 02, 2016
Pharmaceutical Technology
Scale-down modeling is instrumental in supporting the development of downstream biopharma manufacturing processes.
Feb 01, 2016
Pharmaceutical Technology
The reporter bioassay, used to evaluate ADCC activity of therapeutic antibodies, complements the classical ADCC assay.
Jan 28, 2016
By Pharmaceutical Technology Editors
NICE announces plans to back biosimilar alternatives to Merck’s Remicade.
Jan 04, 2016
BioPharm highlights the monoclonal antibodies that may gain United States regulatory approval in 2016.
Dec 17, 2015
By Pharmaceutical Technology Editors
Synpromics announced collaborations with Avalanche Biotechnologies and Applied Genetic Technologies Corporation to use synthetic promoters to develop gene therapies, including adeno-associated virus technology for treating eye diseases.
Dec 16, 2015
Equipment and Processing Report
Collaboration between users and suppliers to increase understanding, clearly define user requirements, and mitigate risk is facilitating acceptance by industry and regulators.
Dec 11, 2015
By Pharmaceutical Technology Editors
Millipore Express PHF hydrophilic, sterilizing-grade filters from EMD Millipore offer faster flow rates to speed the process or reduce the process footprint.
Dec 02, 2015
PTSM: Pharmaceutical Technology Sourcing and Management
The CEO of a US-based biosimilar manufacturer explains the legal and intellectual property issues of bringing a biosimilar to market in the United States.
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