Zoekresultaten - 28 results

Setting specifications for Biologicals. Points to consider from simple to complex. Case study for viral vectored vaccines.

Publication Type: Scientific poster, presentation or proceeding Authors: Wim Van Molle Source: 2017 BioMAN Workshop on Setting Specifications for Biotherapeutic Products, BioMAN, Issue BioMAN, Cambridge, MA, USA (2017) Keywords: vaccine Health Topics:  Va ...

Panel discussion on specifications for biologicals

Publication Type: Scientific poster, presentation or proceeding Authors: Wim Van Molle Source: 2017 BioMAN Workshop on Setting Specifications for Biotherapeutic Products, BioMAN, Issue BioMAN, Cambridge, MA, USA (2017) Keywords: vaccine Health Topics:  Va ...

Quality Control of Polysaccharide Vaccines by the Belgian National Control Lab (OMCL) in the European Batch Release Framework: Activity Report 2016

Publication Type: Sci. report, recommendat°, guidance doc., directive, monograph Authors: L. Tesolin; Wim Van Molle Source: Scientific Institute of Public Health, Brussels, Belgium, p.59 (2017) ISBN: D/2017/2505/44 Accession Number: D/2017/2505/44 Keyword ...

Evaluation of quality and non-clinical data for licencing of vaccines

Publication Type: Scientific poster, presentation or proceeding Authors: Wim Van Molle Source: WHO GLO Evaluation of quality and non-clinical data for licensing of vaccines, WHO, Issue WHO, Athens, Greece (2016) Keywords: vaccine Health Topics:  Vaccine b ...

Batch release of vaccines in Europe: from method transfer to first commercial batch available on the market. Straightforward approach that requires a proactive mind-set of the manufacturer.

Publication Type: Scientific poster, presentation or proceeding Authors: Wim Van Molle; L. Tesolin; Koen Brusselmans; Geneviève Waeterloos Source: PDA Europe Conference Vaccines. Featuring WHO on Challenges in Vaccines Supply to Developing Countries, PDA ...

Testing of expired Synflorix bulks: actions taken by three OMCLs and concerns raised by another OMCL.

Publication Type: Scientific poster, presentation or proceeding Authors: Wim Van Molle Source: Annual OMCL meeting, EDQM, Issue EDQM, Brussels, Belgium (2015) Keywords: batch release meeting TESTING Health Topics:  Vaccine batch conformity Vaccin lot conf ...

The Biological Standardisation activities at the international level

Publication Type: Scientific poster, presentation or proceeding Authors: Wim Van Molle Source: Quality control and batch release of vaccines and blood products in Europe, WIV-ISP, Issue WIV-ISP, Brussels, Belgium (2015) Keywords: Activity at batch release ...

Vaxelis (PR5I): another fully liquid hexavalent vaccine on the EU market in 2016.

Publication Type: Scientific poster, presentation or proceeding Authors: Wim Van Molle Source: Annual OMCL meeting, EDQM, Issue EDQM, Brussels, Belgium (2015) Keywords: EU meeting ON vaccine Health Topics:  Vaccine batch conformity Vaccin lot conformiteit ...

Quality Control of polysaccharide Vaccines by the Belgian National Control Lab (OMCL) in the European Batch Release Framework: Activity Report 2014

Publication Type: Sci. report, recommendat°, guidance doc., directive, monograph Authors: L. Tesolin; Wim Van Molle Source: Scientific Institute Public Health, Brussels, Belgium, p.73 (2015) ISBN: D/2015/2505/82 Accession Number: D/2015/2505/82 Keywords: ...

Quality Control of Polysaccharide Vaccines by the Belgian National Control Lab (OMCL) in the European Batch Release Framework: Activity Report 2013

Publication Type: Sci. report, recommendat°, guidance doc., directive, monograph Authors: L. Tesolin; Wim Van Molle Source: Scientific Institute of Public Health, Brussels, Belgium, p.74 (2014) ISBN: D/2014/2505/42 Accession Number: D/2014/2505/42 Keyword ...

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