Publications

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14 12, 2015

Hurdles in clinical implementation of academic ATMPs: A national evaluation

By | December 14th, 2015|News, Publications|0 Comments

Hurdles in clinical implementation of academic advanced therapy medicinal products: A national evaluation SOFIEKE DEWILDE1, LOUISE VELTROP-DUITS1, MEREL HOOZEMANS-STRIK2, THIRZA RAS3, JANINE BLOM-VEENMAN3, HENK-JAN GUCHELAAR1, MAARTEN ZANDVLIET1 & PAULINE MEIJ1 [...]

12 03, 2015

New tools for ATMPs

By | March 12th, 2015|News, Project, Publications|0 Comments

Hannover Medical School, Germany, received the manufacturing license for Cytomegalovirus (CMV)-specific T cells in April 2014 (Tischer et al. 2014) and for Epstein Barr (EBV) and Adenovirus (ADV) specific T [...]

12 02, 2015

EMA consultation: Concept paper on the revision of annex 1 of the guidelines on good manufacturing practice – manufacture of sterile medicinal products- open for comments

By | February 12th, 2015|Publications, Uncategorized|0 Comments

The EMA has released for public consultation a concept paper on the revision of annex 1 of the guidelines on good manufacturing practice – manufacture of sterile medicinal products. The [...]

12 02, 2015

MHRA Review of Deficiencies Observed during GMP Inspection in 2013

By | February 12th, 2015|Publications|0 Comments

During 2013 the MHRA performed 174 inspections in the UK and 42 overseas. The top 5 categories where the most defects were observed are: • Investigation in anomalies • Quality [...]

4 02, 2015

New publication about CMV-CTL manufacturing as an ATMP

By | February 4th, 2015|Publications|0 Comments

A new publication about CMV-CTL manufacturing as an ATMP has been pusblished. Prof Dr. Ulrike Köhl (AGORA)  is one of the authors. Tischer S, Priesner C, Heuft HG, Goudeva L, [...]