ࡱ> MOLq` bjbjqPqP .B::^^^^^^^rrYp$Gh!^FFF^^F0^^F^^ K%v"<)0Y}"^}"}"^<"8Pd YFFFFrrrd $rrrrrr^^^^^^ Fraunhofer Institute for Cell Therapy and ImmunologyGMP compliant manufacturing of biologics like cell therapeutics, tissue engineering products, stem cell therapeutics, cancer vaccines, gene therapeutics, therapeutic monoclonal antibodies, recombinant glycoproteins Contact person details Name: SCHMIEDEKNECHT , Gerno ( Ph.D.) Name of Organisation: Fraunhofer SocietyURL:  HYPERLINK "http://www.izi.fraunhofer.de/" \t "_blank" http://www.izi.fraunhofer.de/E-mail:  HYPERLINK "http://cordis.europa.eu/MailAnon/index.cfm?fuseaction=Hiding.PostalForm&address=006700650072006e006f002e007300630068006d0069006500640065006b006e006500630068007400400069007a0069002e0066007200610075006e0068006f006600650072002e00640065" \t "_blank" ContactTelephone: +49-0341-35536410Fax number: +49-0341-35536109 Collaboration Type: Company ExpertiseTitle: GMP compliant manufacturing of biologics like cell therapeutics, tissue engineering products, stem cell therapeutics, cancer vaccines, gene therapeutics, therapeutic monoclonal antibodies, recombinant glycoproteinsParticipation: Type AType Details: The GMP - manufacturing group of the Fraunhofer Institute for Cell Therapy and Immunology (IZI) offers it's project partners from pharmaceutical and biotechnology companies, research institutes and universities a full service package around the topic GMP - compliant manufacturing of biologics for clinical trials. These services include: GMP-manufacturing of autologous or allogeneic cell-based therapeutics (e.g. tissue engineering products, adult stem cell based therapeutics, cancer vaccines, gene therapeutics). GMP-manufacturing of therapeutic recombinant glycoproteins and antibodies in small batch size (for phase I or early phase II trials) using mammalian cell lines. Support in set-up and validation of GMP-compliant manufacturing processes and quality control procedures as well as in applying for a manufacturing authorisation according to 13 German Drug Act (Arzneimittelgesetz, AMG). Transfer of projects from research & development to a GMP-compliant level (process development). Consultancy regarding set-up of a quality assurance system that adheres to the EC Guide to Good Manufacturing Practice. Renting of separate clean room suites with customer responsibility for all manufacturing processes including own manufacturing authorisation according to 13 AMG. For these services mentioned above we provide a state of the art multi purpose clean room facility of 450 square meters as well as a highly qualified interdisciplinary team. Please contact: Fraunhofer Institute for Cell Therapy and Immunology (IZI) Dr. Gerno Schmiedeknecht Deutscher Platz 5e D-04103 Leipzig phone: +49 (0)30 35536410 fax: +49 (0)30 35536109 Email:  HYPERLINK "http://cordis.europa.eu/MailAnon/index.cfm?fuseaction=Hiding.PostalForm&address=006700650072006e006f002e007300630068006d0069006500640065006b006e006500630068007400400069007a0069002e0066007200610075006e0068006f006600650072002e00640065" \t "_blank" ContactProgramme:  HYPERLINK "http://cordis.europa.eu/search/index.cfm?fuseaction=prog.simpledocument&PG_RCN=7150618" FP7 ,  HYPERLINK "http://cordis.europa.eu/search/index.cfm?fuseaction=prog.simpledocument&PG_RCN=8737568" FP7-KBBE ,  HYPERLINK "http://cordis.europa.eu/search/index.cfm?fuseaction=prog.simpledocument&PG_RCN=8737570" FP7-HEALTH Instruments: CP Collaborative project (generic),LCP Large collaborative project,MCP Medium size Collaborative project,SSCP Series of small collaborative project(s)Research interest: Expiry Date: 2008-11-09Workprogramme area(s)/key action(s):  Target Partner Expertise: We are seeking for partners, e.g. pharmaceutical or biotechnology companies, research institutes that are interested in pharmaceutical development and manufacturing of new active pharmaceutical ingredients and therapeutics of biological origin and would like to seamlessly segue into clinical trials.Country: World Organization Details Name: Fraunhofer SocietyDepartment: GMP-facility Address: Leipzig DEUTSCHLAND Type: ResearchNumber of Employees: 250 - 500Details: Keywords: GMP cGMP manufacturing tissue engineering cell therapy monoclonal antibodies glycoproteins Partners already acquired:  456   % & ' ( . / = O P Q g h z { |      / 0 1 2 ? @ A B H Y Z [ b 8 9 : I O P Q _ 꾰꾰hq20JCJOJQJaJ(jhq2B* CJOJQJUaJph hq20Jhq20J5\hq2CJaJhq2B* CJOJQJaJph hq20JE56   & vqgdq2<kd_$$IfT<634<aT$If<kd$$IfT<634<aT $$Ifa$& ' ( / P Q h { >jkd<$$IfT<0z 634<apT$Ifgdq2Lkd$$IfT<  634<ap T{ | %jkd$$IfT<0z 634<apT$Ifjkd$$IfT<0z 634<apT  jkd.$$IfT<0z 634<apT$If   0 1 %jkdv$$IfT<0z 634<apT$Ifjkd$$IfT<0z 634<apT1 2 @ A Z [ 9 k<kd$$IfT<634<aTLkd$$IfT<  634<ap T$Ifgdq29 : P Q SB<kd$$IfT<634<aT<kdJ$$IfT<634<aT$If<kd$$IfT<634<aT hj  OQnp 02mnfgjknoEFPQRSTa  %&'LMNOhq20J5\hq2CJaJhq20JCJOJQJaJjhq20JU hq20Jhq2B* CJOJQJaJphKST &B<kd$$IfT<634<aT<kdU$$IfT<634<aT$If<kd$$IfT<634<aT&'MNO^zgdq2<kd`$$IfT<634<aT$If<kd$$IfT<634<aTO]^_`kl~ "#+,-BCIJMNOXZ[efijno|}h\ hq20Jhq20J5\hq2CJaJhq2B* CJOJQJaJph hq20JL^_p3<kd $$IfT<634<aT<kd7 $$IfT<634<aT$IfLkd$$IfT<  634<ap T>jkdg $$IfT<0z 634<apTLkd $$IfT<  634<ap T$Ifgdq2jkd $$IfT<0z 634<apT$If#,-%jkde $$IfT<0z 634<apT$Ifjkd $$IfT<0z 634<apT-CNOYZjkd $$IfT<0z 634<apT$IfZ[f%jkdc$$IfT<0z 634<apT$Ifjkd $$IfT<0z 634<apT_kd $$IfT<0z  634<ap T$If,1h/ =!"#$% ]$$If!vh5#v:V <6,534<T]$$If!vh5#v:V <6,534<T|$$If!vh5#v:V <  6,534<p T$$If!vh55!#v#v!:V < 6,5534<pT$$If!vh55!#v#v!:V < 65534<pT$$If!vh55!#v#v!:V < 65534<pT$$If!vh55!#v#v!:V < 65534<pT$$If!vh55!#v#v!:V < 65534<pT$$If!vh55!#v#v!:V < 65534<pT|$$If!vh5#v:V <  6,534<p TW$$If!vh5#v:V <6534<TW$$If!vh5#v:V <6534<TW$$If!vh5#v:V <6534<TW$$If!vh5#v:V <6534<TW$$If!vh5#v:V <6534<TW$$If!vh5#v:V <6534<TW$$If!vh5#v:V <6534<TW$$If!vh5#v:V <6534<TW$$If!vh5#v:V <6534<T|$$If!vh5#v:V <  6,534<p TW$$If!vh5#v:V <6534<TW$$If!vh5#v:V <6534<T|$$If!vh5#v:V <  6,534<p T$$If!vh55!#v#v!:V < 6,5534<pT$$If!vh55!#v#v!:V < 6,5534<pT$$If!vh55!#v#v!:V < 6,5534<pT$$If!vh55!#v#v!:V < 6,5534<pT$$If!vh55!#v#v!:V < 6,5534<pT$$If!vh55!#v#v!:V < 6,5534<pT$$If!vh55!#v#v!:V < 6,5534<pT$$If!vh55!#v#v!:V <  6,5534<p T@@@ NormalCJ_HaJmH sH tH DA@D Default Paragraph FontRi@R  Table Normal4 l4a (k@(No List4U`4 q2 Hyperlink >*phDoD q2title15CJOJQJ\aJo(ph@<o< q2main1CJOJQJaJo(phB56 &'(/PQh{|012@AZ[9:PQ S T &'MNO^_#,-CNOYZ[f@0 @0 I0 @0 @0I0 @0 I0I0 I0 @0 I0  I0  @0 I0  I0  @0 I0  I0  @0 I0 I0 @0 I0 I0 @0 I0I0 @0 I0 @0 I0 @0 I0 @0 I0 @0 I0 @0 I0 @0 I0! @0 I0# @0 I0% @0 I0'I0' @0 I0) @0 I0+ @0 I0-I0- @0 I0/I0/ I0/ @0 I01 I01 @0 I03 I03 @0 I05 I05 @0 I07 I07 @0 I09 I09 @0 I0; I0; @0 I0= I0= @0 I056 &'PQ{|01@AZ[9:PQ S T &'MN^_,-NOZ[fK0\K0 K00\K0 K0h\K0 K0\K0 K0 ،\I0 K0  C\I0 K0  E\K0 K0,H\K0 K0dH\K0 K0D\K0 K0E\K0 K08E\K0 K0H\K0 K0I\K0 K0?@ABCEFGHIJKNRoot Entry FH\%PData "1Table*}"WordDocument.BSummaryInformation(<DocumentSummaryInformation8DCompObjq  FMicrosoft Office Word Document MSWordDocWord.Document.89q