A Biopharmaceutical Industry Perspective on the Control of Visible Particles in Biotechnology-Derived Injectable Drug Products
For the past two years, representatives from eight different pharmaceutical companies which manufacture biotechnological products have been discussing visible particles. The probability of seeing a...
Read moreEuropaBio and EBE host a multi-stakeholder debate on the labelling of biosimilar medicines
On 2 February 2016, EuropaBio, the European Association for Bio Industries, and EBE, the European Biopharmaceutical Enterprises, jointly facilitated a multi-stakeholder workshop in Brussels on the...
Read moreEBE White Paper on Personalised Medicine
Personalised medicine aims to deliver the right medicine to the right patient at the right time. It targets treatments to patients that are most likely to benefit from them, in contrast to the traditi...
Read moreA Risk-Based Approach to Sterile Filtration Bioburden Limits
4 May 2015: Discussion of the current thinking in the Industry with Stakeholders at the CASSS CMC Strategy Forum Europe 2015....
Read moreTell me the whole story: the role of product labelling in building user confidence in biosimilars in Europe
The European Medicines Agency (EMA) has led the development of biosimilar regulatory pathways globally, tailoring their approach to meet the specific and scientifically determined needs of biosimilar...
Read moreEBE and ESCHER launched new project ‘Pharmacovigilance of biologics’
Escher, the TI Pharma platform for regulatory innovation, launched a new project,‘Pharmacovigilance of biologics’ in November 2014. It will address the challenges of product and batch traceabilit...
Read moreEBE Position Paper on the Use of Omics Technologies in the Development of Personalised Medines
The European Commission (EC) has recently published a report on ‘Use of '-omics' technologies in the development of personalised medicine’. The report has been analysed by European Biopharmaceutic...
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