Publications

03 Aug 2016

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...

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22 Feb 2016

EuropaBio 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...

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15 Sep 2015

EBE Concept Paper: Forced Degradation Studies for Therapeutic Proteins

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04 Sep 2015

EBE 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...

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04 May 2015

A 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....

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03 Feb 2015

Destination Europe

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10 Dec 2014

Tell 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...

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30 Nov 2014

EBE 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...

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13 Nov 2014

BIOPHARMA: DISCOVER • DEVELOP • DELIVER

Booklet Annex ...

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16 Dec 2013

EBE 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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