Research ArticleConference Report
Meeting Report: PDA Virus and TSE Safety Forum
Hannelore Willkommen, Johannes BlüMel, Kurt Brorson, Dayue Chen, Qi Chen, Albrecht GröNer, Thomas R. Kreil, James S. Robertson, Michel Ruffing and Sol Ruiz
PDA Journal of Pharmaceutical Science and Technology March 2013, 67 (2) 81-97; DOI: https://doi.org/10.5731/pdajpst.2013.00906
Hannelore Willkommen
aRegulatory Affairs & Biological Safety Consulting, Erzhausen, Germany;
Johannes BlüMel
bPaul-Ehrlich Institut, Langen, Germany;
Kurt Brorson
cCDER/FDA, Silver Spring MD, USA;
Dayue Chen
dEli Lilly and Company, Indianapolis, IN, USA;
Qi Chen
eGenentech Inc., Genentech, Inc., South San Francisco, CA, USA;
Albrecht GröNer
fCSL Behring GmbH, Marburg, Germany;
Thomas R. Kreil
gBaxter BioScience, Vienna, Austria;
James S. Robertson
hNational Institute for Biological Standards and Control, Potters Bar, UK;
Michel Ruffing
iBoehringer Ingelheim Pharma GmbH&KG, Bieberach an der Riss, Germany; and
Sol Ruiz
jSpanish Medicines Agency (AEMPS), Madrid, Spain

References
- 1.↵
ICH Q5A (R1): Quality of biotechnological products: viral safety evaluation of biotechnology products derived from cell lines of human or animal origin. CPMP/ICH/295/95. October 1997. http://www.ema.europa.eu.
- 2.↵
- Victoria J. G.,
- Wang C.,
- Jones M. S.,
- Jaing C.,
- McLoughlin K.,
- Gardner S.,
- Delwart E. L.
- 3.↵
EMA/CHMP/BWP/548524/2008: Guideline on epidemiological data on blood transmissible infection. 22 April 2010. http://www.ema.europa.eu.
- 4.↵
- Murphy M.,
- Quesada G. M.,
- Chen D.
- 5.↵
- Onions D.,
- Kolman J.
- 6.↵
- Sampath R.,
- Blyn L. B.,
- Ecker D. J.
- 7.↵
- C. R. Ill.,
- Dehghani H.
- 8.↵
- Lawrence B.,
- Bashiri H.,
- Dehghani H.
- 9.↵
- Lamson D.,
- Renwick N.,
- Kapoor V.,
- Liu Z.,
- Palacios G.,
- Ju J.,
- Dean A.,
- St. George K.,
- Briese T.,
- Lipkin W. I.
- 10.↵
- Palacios G.,
- Quan P.-L.,
- Jabado O. J.,
- Conlan S.,
- Hirschberg D. L.,
- Liu Y.,
- Zhai J.,
- Renwick N.,
- Hui J.,
- Hegyi H.,
- Grolla A.,
- Strong J. E.,
- Towner J. S.,
- Geisbert T. W.,
- Jarhling P. B.,
- Büchen-Osmond C. V.,
- Ellerbrok H.,
- Sanchez-Seco M. P.,
- Lussier Y.,
- Formenty P.,
- Nichol S. T.,
- Feldmann H.,
- Briese T.,
- Lipkin W. I.
- 11.↵
- Briese T.,
- Paweska J. T.,
- McMullan L. K.,
- Hutchison S. K.,
- Street C.,
- Palacios G.,
- Khristova M. L.,
- Weyer J.,
- Swanepoel R.,
- Egholm M.,
- Nichol S. T.,
- Lipkin W. I.
- 12.↵
- Quan P. L.,
- Wagner T. A.,
- Briese T.,
- Torgerson T. R.,
- Hornig M.,
- Tashmukhamedova A.,
- Firth C.,
- Palacios G.,
- Baisre-de-Leon A.,
- Paddock C. D.,
- Hutchison S. K.,
- Egholm M.,
- Zaki S. R.,
- Goldman J. E.,
- Ochs H. D.,
- Lipkin W. I.
- 13.↵
- Farcet M. R.,
- Kindermann J.,
- Modrof J.,
- Kreil T. R.
- 14.↵
- Miesegaes G.,
- Bailey M.,
- Willkommen H.,
- Chen Q.,
- Roush D.,
- Blümel J.,
- Brorson K.
- 15.↵
- Dichtelmuller H. O.,
- Biesert L.,
- Fabrizzi F.,
- Gajardo R.,
- Groner H.,
- Jorquera J. I.,
- Kempf C.,
- Kreil T. R.,
- Pifat W.,
- Osheroff W.,
- Poelsler G.
- 16.↵
EMEA/CHMP/BWP/398498/2005: Guideline on virus safety evaluation of biotechnological investigational medicinal products. 1 February 2009. http://www.ema.europa.eu.
- 17.↵
OIE-World Organization of Animal Health: Bovine Spongiform Encephalopathy Status of Members according to Resolution No. 17, May 2011, http://www.oie.int/animal-health-in-the-world/official-disease-status/bse/list-of-bse-risk-status/.
- 18.↵
National Blood Service: Transfusion Medicine Epidemiologial Review (TMER). http://www.cjd.ed.ac.uk/TMER/TMER.htm.
- 19.↵
- Peden A.,
- McCardle L.,
- Head M. W.,
- Love S.,
- Ward H. J. T.,
- Cousens S. N.,
- Keeling D. M.,
- Millar C. M.,
- Hill F. G. H.,
- Ironside J. W.
- 20.↵
- Puopolo M.,
- Ladogana A.,
- Vetrugno V.,
- Pocchiari M.
- 21.↵
European Commission: Note for guidance on minimizing the risk of transmitting animal spongiform encephalopathy agents via human and veterinary medicinal products (EMA/410/01 rev. 3). OJ C73, 5.3.2011, pp 1–18.
- 22.↵
OIE: Terrestrial Animal Health Code, Chapter 11.5.: bovine spongiform encephalopathy. http://www.oie.int/index.php?id=169&L=0&htmfile=chapitre_1.11.5.htm.
- 23.↵
EMA/CHMP/BWP/303353/2010: CHMP position statement on Creutzfeldt-Jakob disease and plasma-derived and urine-derived medicinal products. 23 June 2011. http://www.ema.europa.eu.
- 24.↵
- Hilton D. A.,
- Ghani A. C.,
- Conyers L.,
- Edwards P.,
- McCardle L.,
- Ritchie D.,
- Penney M.,
- Hegazy D.,
- Ironside J. W.
- 25.↵
- de Marco M. F.,
- Linehan J.,
- Gill O. N.,
- Clewley J. P.,
- Brandner S.
- 26.↵
- Gregori L.,
- Kovacs G. G.,
- Alexeeva I.,
- Budka H.,
- Rohwer R. G.
- 27.↵
- Edgeworth J. A.,
- Farmer M.,
- Sicilia A.,
- Tavares P.,
- Beck J.,
- Campbell T.,
- Lowe J.,
- Mead S.,
- Rudge P.,
- Collinge J.,
- Jackson G. S.
- 28.↵
- Wilham J. M.,
- Orrú C. D.,
- Bessen R. A.,
- Atarashi R.,
- Sano K.,
- Race B.,
- Meade-White K. D.,
- Taubner L. M.,
- Timmes A.,
- Caughey B.
- 29.↵
- Pritzkow S.,
- Wagenführ K.,
- Daus M. L.,
- Boerner S.,
- Lemmer K.,
- Thomzig A.,
- Mielke M.,
- Beekes M.
- 30.↵
- Thyer J.,
- Unal A.,
- Hartel G.,
- Middleton D.,
- Bingham J.,
- Braun M.,
- Uren E.,
- Maher D.
- 31.↵
CPMP/BWP/5136/03: Guideline on the investigation of manufacturing processes for plasma-derived medicinal products with regards to vCJD. 21 October 2004. http://www.ema.europa.eu.
- 32.↵
- Yunoki M.,
- Tanaka H.,
- Urayama T.,
- Hattori S.,
- Ohtani M.,
- Ohkubo Y.,
- Kawabata Y.,
- Miyatake Y.,
- Nanjo A.,
- Iwao E.,
- Morita M.,
- Wilson E.,
- MacLean C.,
- Ikuta K.
- 33.↵
- Safar J. G.,
- Geschwind M. D.,
- Deering C.,
- Didorenko S.,
- Sattavat M.,
- Sanchez H.,
- Serban A.,
- Vey M.,
- Baron H.,
- Giles K.,
- Miller B. L.,
- DeArmond S. J.
In This Issue
PDA Journal of Pharmaceutical Science and Technology
Vol. 67, Issue 2
March/April 2013
Meeting Report: PDA Virus and TSE Safety Forum
Hannelore Willkommen, Johannes BlüMel, Kurt Brorson, Dayue Chen, Qi Chen, Albrecht GröNer, Thomas R. Kreil, James S. Robertson, Michel Ruffing, Sol Ruiz
PDA Journal of Pharmaceutical Science and Technology Mar 2013, 67 (2) 81-97; DOI: 10.5731/pdajpst.2013.00906
Jump to section
Related Articles
- No related articles found.