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004662

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004662/0000/m1/eu/10-cover/ema/ema-cover.pdf 222 KB
004662/0000/m1/eu/10-cover/ema/ema-cover-gcp.pdf 408 KB
004662/0000/m1/eu/10-cover/ema/ema-cover-glp.pdf 118 KB
004662/0000/m1/eu/10-cover/ema/ema-cover-prime.pdf 180 KB
004662/0000/m1/eu/10-cover/ema/ema-tracking.pdf 46 KB
004662/0000/m1/eu/12-form/ema/ema-form-eaf.pdf 1.1 MB
004662/0000/m1/eu/12-form/ema/ema-form-annex-503.pdf 157 KB
004662/0000/m1/eu/12-form/ema/ema-form-annex-504.pdf 19 KB
004662/0000/m1/eu/12-form/ema/ema-form-annex-505.pdf 558 KB
004662/0000/m1/eu/12-form/ema/ema-form-annex-506-cel-bv.pdf 102 KB
004662/0000/m1/eu/12-form/ema/ema-form-annex-506-ccmp.pdf 531 KB
004662/0000/m1/eu/12-form/ema/ema-form-annex-506-celgene.pdf 61 KB
004662/0000/m1/eu/12-form/ema/ema-form-annex-508.pdf 71 KB
004662/0000/m1/eu/12-form/ema/ema-form-annex-509-fisher.pdf 131 KB
004662/0000/m1/eu/12-form/ema/ema-form-annex-509-mvz.pdf 142 KB
004662/0000/m1/eu/12-form/ema/ema-form-annex-509-cel-bv.pdf 136 KB
004662/0000/m1/eu/12-form/ema/ema-form-annex-509-fisher-frederick.pdf 31 KB
004662/0000/m1/eu/12-form/ema/ema-form-annex-509-ccmp.pdf 141 KB
004662/0000/m1/eu/12-form/ema/ema-form-annex-512.pdf 1 MB
004662/0000/m1/eu/12-form/ema/ema-form-annex-513.pdf 5.5 MB
004662/0000/m1/eu/12-form/ema/ema-form-annex-514-chmp-jul2017.pdf 629 KB
004662/0000/m1/eu/12-form/ema/ema-form-annex-514-chmp-qual-feb2019.pdf 781 KB
004662/0000/m1/eu/12-form/ema/ema-form-annex-514-chmp-clin-mar2019.pdf 638 KB
004662/0000/m1/eu/12-form/ema/ema-form-annex-514-chmp-qua-jun2019.pdf 987 KB
004662/0000/m1/eu/12-form/ema/ema-form-annex-514-chmp-clin-jun2019.pdf 705 KB
004662/0000/m1/eu/12-form/ema/ema-form-annex-514-chmp-qual-apr2018.pdf 1 MB
004662/0000/m1/eu/12-form/ema/ema-form-annex-514-chmp-qual-pei.pdf 197 KB
004662/0000/m1/eu/12-form/ema/ema-form-annex-514-chmp-clin-pei.pdf 116 KB
004662/0000/m1/eu/12-form/ema/ema-form-annex-514-ansm.pdf 26 KB
004662/0000/m1/eu/12-form/ema/ema-form-annex-514-aemp.pdf 820 KB
004662/0000/m1/eu/12-form/ema/ema-form-annex-514-famhp.pdf 1.6 MB
004662/0000/m1/eu/12-form/ema/ema-form-annex-514-rapp-mm.pdf 261 KB
004662/0000/m1/eu/12-form/ema/ema-form-annex-514-ema-mm.pdf 247 KB
004662/0000/m1/eu/12-form/ema/ema-form-annex-517.pdf 8.3 MB
004662/0000/m1/eu/12-form/ema/ema-form-annex-518-mm.pdf 582 KB
004662/0000/m1/eu/12-form/ema/ema-form-annex-518-celgene-eu-ltd.pdf 80 KB
004662/0000/m1/eu/12-form/ema/ema-form-annex-518-celgene-eu-bv.pdf 86 KB
004662/0000/m1/eu/12-form/ema/ema-form-annex-521.pdf 336 KB
004662/0000/m1/eu/12-form/ema/ema-form-annex-522.pdf 1 MB
004662/0000/m1/eu/12-form/ema/ema-form-annex-523.pdf 489 KB
004662/0000/m1/eu/13-pi/131-spclabelpl/ema/en/ema-combined-h004662enclean.pdf 340 KB
004662/0000/m1/eu/13-pi/132-mockup/ema/ema-mockup-250ml-cassette-en.pdf 852 KB
004662/0000/m1/eu/13-pi/132-mockup/ema/ema-mockup-250ml-cassette-fr-de-nl.pdf 877 KB
004662/0000/m1/eu/13-pi/132-mockup/ema/ema-mockup-250ml-infusion-bag-en.pdf 843 KB
004662/0000/m1/eu/13-pi/132-mockup/ema/ema-mockup-250ml-infusion-bag-fr-de-nl.pdf 861 KB
004662/0000/m1/eu/13-pi/132-mockup/ema/ema-mockup-50ml-cassette-en.pdf 835 KB
004662/0000/m1/eu/13-pi/132-mockup/ema/ema-mockup-50ml-cassette-fr-de-nl.pdf 855 KB
004662/0000/m1/eu/13-pi/132-mockup/ema/ema-mockup-50ml-infusion-bag-en.pdf 827 KB
004662/0000/m1/eu/13-pi/132-mockup/ema/ema-mockup-50ml-infusion-bag-fr-de-nl.pdf 847 KB
004662/0000/m1/eu/13-pi/132-mockup/ema/ema-mockup-pil-en.pdf 491 KB
004662/0000/m1/eu/13-pi/134-consultation/ema/ema-consultation.pdf 148 KB
004662/0000/m1/eu/13-pi/136-braille/braille.pdf 8 KB
004662/0000/m1/eu/14-expert/141-quality/quality-expert.pdf 188 KB
004662/0000/m1/eu/14-expert/141-quality/quality-cv.pdf 84 KB
004662/0000/m1/eu/14-expert/142-nonclinical/nonclinical-expert.pdf 38 KB
004662/0000/m1/eu/14-expert/142-nonclinical/nonclinical-cv.pdf 376 KB
004662/0000/m1/eu/14-expert/143-clinical/clinical-expert.pdf 18 KB
004662/0000/m1/eu/14-expert/143-clinical/clinical-cv.pdf 571 KB
004662/0000/m1/eu/16-environrisk/162-gmo/gmo.pdf 151.9 MB
004662/0000/m1/eu/17-orphan/171-similarity/similarity.pdf 595 KB
004662/0000/m1/eu/18-pharmacovigilance/181-phvig-system/phvigsystem.pdf 112 KB
004662/0000/m1/eu/18-pharmacovigilance/182-riskmgt-system/riskmgtsystem.pdf 2.1 MB
004662/0000/m1/eu/18-pharmacovigilance/182-riskmgt-system/riskmgtsystem-annex.pdf 463 KB
004662/0000/m1/eu/19-clinical-trials/clinicaltrials.pdf 14 KB
004662/0000/m1/eu/110-paediatrics/paediatrics-information.pdf 120 KB
004662/0000/m1/eu/110-paediatrics/paediatrics-pip-decision.pdf 318 KB
004662/0000/m1/eu/110-paediatrics/paediatrics-compliance.pdf 117 KB
004662/0000/m2/22-intro/introduction.pdf 66 KB
004662/0000/m2/23-qos/introduction.pdf 265 KB
004662/0000/m2/23-qos/introduction-01.pdf 2.9 MB
004662/0000/m2/23-qos/drug-substance.pdf 741 KB
004662/0000/m2/23-qos/drug-substance-lvv.pdf 1.1 MB
004662/0000/m2/23-qos/drug-product.pdf 287 KB
004662/0000/m2/23-qos/drug-product-qos-exemption.pdf 231 KB
004662/0000/m2/23-qos/appendices.pdf 139 KB
004662/0000/m2/23-qos/regional-information.pdf 78 KB
004662/0000/m2/24-nonclin-over/nonclinical-overview.pdf 814 KB
004662/0000/m2/24-nonclin-over/nonclinical-overview-justification.pdf 82 KB
004662/0000/m2/25-clin-over/clinical-overview.pdf 2.2 MB
004662/0000/m2/25-clin-over/30-day-eff-info.pdf 333 KB
004662/0000/m2/26-nonclin-sum/introduction.pdf 89 KB
004662/0000/m2/26-nonclin-sum/pharmacol-written-summary.pdf 2 MB
004662/0000/m2/26-nonclin-sum/pharmacol-tabulated-summary.pdf 128 KB
004662/0000/m2/26-nonclin-sum/pharmkin-written-summary.pdf 171 KB
004662/0000/m2/26-nonclin-sum/pharmkin-tabulated-summary.pdf 154 KB
004662/0000/m2/26-nonclin-sum/toxicology-written-summary.pdf 1.1 MB
004662/0000/m2/26-nonclin-sum/toxicology-tabulated-summary.pdf 109 KB
004662/0000/m2/27-clin-sum/summary-biopharm.pdf 157 KB
004662/0000/m2/27-clin-sum/summary-clin-pharm.pdf 6.3 MB
004662/0000/m2/27-clin-sum/summary-clin-efficacy-mm.pdf 1.2 MB
004662/0000/m2/27-clin-sum/summary-clin-safety.pdf 2.1 MB
004662/0000/m2/27-clin-sum/literature-references.pdf 60 KB
004662/0000/m2/27-clin-sum/synopses-indiv-studies.pdf 72 KB
004662/0000/m3/32-body-data/32s-drug-sub/ide-cel-all/32s1-gen-info/nomenclature.pdf 53 KB
004662/0000/m3/32-body-data/32s-drug-sub/ide-cel-all/32s1-gen-info/structure.pdf 185 KB
004662/0000/m3/32-body-data/32s-drug-sub/ide-cel-all/32s1-gen-info/general-properties.pdf 63 KB
004662/0000/m3/32-body-data/32s-drug-sub/ide-cel-all/32s2-manuf/manufacturer.pdf 62 KB
004662/0000/m3/32-body-data/32s-drug-sub/ide-cel-all/32s2-manuf/manuf-process-and-controls.pdf 248 KB
004662/0000/m3/32-body-data/32s-drug-sub/ide-cel-all/32s2-manuf/control-of-materials.pdf 100 KB
004662/0000/m3/32-body-data/32s-drug-sub/ide-cel-all/32s2-manuf/control-of-materials-01.pdf 74 KB
004662/0000/m3/32-body-data/32s-drug-sub/ide-cel-all/32s2-manuf/control-of-materials-02.pdf 49 KB
004662/0000/m3/32-body-data/32s-drug-sub/ide-cel-all/32s2-manuf/control-of-materials-03.pdf 175 KB
004662/0000/m3/32-body-data/32s-drug-sub/ide-cel-all/32s2-manuf/control-of-materials-04.pdf 65 KB
004662/0000/m3/32-body-data/32s-drug-sub/ide-cel-all/32s2-manuf/control-of-materials-05.pdf 72 KB
004662/0000/m3/32-body-data/32s-drug-sub/ide-cel-all/32s2-manuf/control-of-materials-06.pdf 808 KB
004662/0000/m3/32-body-data/32s-drug-sub/ide-cel-all/32s2-manuf/control-of-materials-07.pdf 1.9 MB
004662/0000/m3/32-body-data/32s-drug-sub/ide-cel-all/32s2-manuf/control-of-materials-08.pdf 217 KB
004662/0000/m3/32-body-data/32s-drug-sub/ide-cel-all/32s2-manuf/control-of-materials-09.pdf 117 KB
004662/0000/m3/32-body-data/32s-drug-sub/ide-cel-all/32s2-manuf/control-of-materials-10.pdf 429 KB
004662/0000/m3/32-body-data/32s-drug-sub/ide-cel-all/32s2-manuf/control-of-materials-11.pdf 1.4 MB
004662/0000/m3/32-body-data/32s-drug-sub/ide-cel-all/32s2-manuf/control-of-materials-12.pdf 1.3 MB
004662/0000/m3/32-body-data/32s-drug-sub/ide-cel-all/32s2-manuf/control-of-materials-13.pdf 663 KB
004662/0000/m3/32-body-data/32s-drug-sub/ide-cel-all/32s2-manuf/control-of-materials-14.pdf 75 KB
004662/0000/m3/32-body-data/32s-drug-sub/ide-cel-all/32s2-manuf/control-of-materials-15.pdf 77 KB
004662/0000/m3/32-body-data/32s-drug-sub/ide-cel-all/32s2-manuf/control-of-materials-16.pdf 119 KB
004662/0000/m3/32-body-data/32s-drug-sub/ide-cel-all/32s2-manuf/control-of-materials-17.pdf 79 KB
004662/0000/m3/32-body-data/32s-drug-sub/ide-cel-all/32s2-manuf/control-of-materials-18.pdf 71 KB
004662/0000/m3/32-body-data/32s-drug-sub/ide-cel-all/32s2-manuf/control-of-materials-19.pdf 105 KB
004662/0000/m3/32-body-data/32s-drug-sub/ide-cel-all/32s2-manuf/control-of-materials-20.pdf 209 KB
004662/0000/m3/32-body-data/32s-drug-sub/ide-cel-all/32s2-manuf/control-of-materials-21.pdf 55 KB
004662/0000/m3/32-body-data/32s-drug-sub/ide-cel-all/32s2-manuf/control-of-materials-22.pdf 91 KB
004662/0000/m3/32-body-data/32s-drug-sub/ide-cel-all/32s2-manuf/control-of-materials-23.pdf 51 KB
004662/0000/m3/32-body-data/32s-drug-sub/ide-cel-all/32s2-manuf/control-of-materials-24.pdf 55 KB
004662/0000/m3/32-body-data/32s-drug-sub/ide-cel-all/32s2-manuf/control-of-materials-25.pdf 52 KB
004662/0000/m3/32-body-data/32s-drug-sub/ide-cel-all/32s2-manuf/control-of-materials-26.pdf 78 KB
004662/0000/m3/32-body-data/32s-drug-sub/ide-cel-all/32s2-manuf/control-of-materials-27.pdf 72 KB
004662/0000/m3/32-body-data/32s-drug-sub/ide-cel-all/32s2-manuf/control-of-materials-28.pdf 88 KB
004662/0000/m3/32-body-data/32s-drug-sub/ide-cel-all/32s2-manuf/control-of-materials-29.pdf 91 KB
004662/0000/m3/32-body-data/32s-drug-sub/ide-cel-all/32s2-manuf/control-of-materials-30.pdf 83 KB
004662/0000/m3/32-body-data/32s-drug-sub/ide-cel-all/32s2-manuf/control-of-materials-31.pdf 78 KB
004662/0000/m3/32-body-data/32s-drug-sub/ide-cel-all/32s2-manuf/control-of-materials-32.pdf 59 KB
004662/0000/m3/32-body-data/32s-drug-sub/ide-cel-all/32s2-manuf/control-of-materials-33.pdf 51 KB
004662/0000/m3/32-body-data/32s-drug-sub/ide-cel-all/32s2-manuf/control-of-materials-34.pdf 52 KB
004662/0000/m3/32-body-data/32s-drug-sub/ide-cel-all/32s2-manuf/control-of-materials-35.pdf 81 KB
004662/0000/m3/32-body-data/32s-drug-sub/ide-cel-all/32s2-manuf/control-of-materials-36.pdf 71 KB
004662/0000/m3/32-body-data/32s-drug-sub/ide-cel-all/32s2-manuf/control-of-materials-37.pdf 410 KB
004662/0000/m3/32-body-data/32s-drug-sub/ide-cel-all/32s2-manuf/control-of-materials-38.pdf 80 KB
004662/0000/m3/32-body-data/32s-drug-sub/ide-cel-all/32s2-manuf/control-of-materials-39.pdf 398 KB
004662/0000/m3/32-body-data/32s-drug-sub/ide-cel-all/32s2-manuf/control-of-materials-40.pdf 72 KB
004662/0000/m3/32-body-data/32s-drug-sub/ide-cel-all/32s2-manuf/control-of-materials-41.pdf 789 KB
004662/0000/m3/32-body-data/32s-drug-sub/ide-cel-all/32s2-manuf/control-of-materials-42.pdf 70 KB
004662/0000/m3/32-body-data/32s-drug-sub/ide-cel-all/32s2-manuf/control-of-materials-43.pdf 300 KB
004662/0000/m3/32-body-data/32s-drug-sub/ide-cel-all/32s2-manuf/control-of-materials-44.pdf 59 KB
004662/0000/m3/32-body-data/32s-drug-sub/ide-cel-all/32s2-manuf/control-of-materials-45.pdf 194 KB
004662/0000/m3/32-body-data/32s-drug-sub/ide-cel-all/32s2-manuf/control-of-materials-46.pdf 58 KB
004662/0000/m3/32-body-data/32s-drug-sub/ide-cel-all/32s2-manuf/control-of-materials-47.pdf 5.2 MB
004662/0000/m3/32-body-data/32s-drug-sub/ide-cel-all/32s2-manuf/control-of-materials-48.pdf 74 KB
004662/0000/m3/32-body-data/32s-drug-sub/ide-cel-all/32s2-manuf/control-of-materials-49.pdf 194 KB
004662/0000/m3/32-body-data/32s-drug-sub/ide-cel-all/32s2-manuf/control-of-materials-50.pdf 64 KB
004662/0000/m3/32-body-data/32s-drug-sub/ide-cel-all/32s2-manuf/control-of-materials-51.pdf 220 KB
004662/0000/m3/32-body-data/32s-drug-sub/ide-cel-all/32s2-manuf/control-of-materials-52.pdf 78 KB
004662/0000/m3/32-body-data/32s-drug-sub/ide-cel-all/32s2-manuf/control-of-materials-53.pdf 179 KB
004662/0000/m3/32-body-data/32s-drug-sub/ide-cel-all/32s2-manuf/control-of-materials-54.pdf 63 KB
004662/0000/m3/32-body-data/32s-drug-sub/ide-cel-all/32s2-manuf/control-of-materials-55.pdf 2.7 MB
004662/0000/m3/32-body-data/32s-drug-sub/ide-cel-all/32s2-manuf/control-of-materials-56.pdf 66 KB
004662/0000/m3/32-body-data/32s-drug-sub/ide-cel-all/32s2-manuf/control-of-materials-57.pdf 6.5 MB
004662/0000/m3/32-body-data/32s-drug-sub/ide-cel-all/32s2-manuf/control-of-materials-58.pdf 64 KB
004662/0000/m3/32-body-data/32s-drug-sub/ide-cel-all/32s2-manuf/control-of-materials-59.pdf 204 KB
004662/0000/m3/32-body-data/32s-drug-sub/ide-cel-all/32s2-manuf/control-of-materials-60.pdf 76 KB
004662/0000/m3/32-body-data/32s-drug-sub/ide-cel-all/32s2-manuf/control-of-materials-61.pdf 466 KB
004662/0000/m3/32-body-data/32s-drug-sub/ide-cel-all/32s2-manuf/control-of-materials-62.pdf 75 KB
004662/0000/m3/32-body-data/32s-drug-sub/ide-cel-all/32s2-manuf/control-of-materials-63.pdf 989 KB
004662/0000/m3/32-body-data/32s-drug-sub/ide-cel-all/32s2-manuf/control-of-materials-64.pdf 73 KB
004662/0000/m3/32-body-data/32s-drug-sub/ide-cel-all/32s2-manuf/control-of-materials-65.pdf 1.1 MB
004662/0000/m3/32-body-data/32s-drug-sub/ide-cel-all/32s2-manuf/control-of-materials-66.pdf 57 KB
004662/0000/m3/32-body-data/32s-drug-sub/ide-cel-all/32s2-manuf/control-of-materials-67.pdf 197 KB
004662/0000/m3/32-body-data/32s-drug-sub/ide-cel-all/32s2-manuf/control-of-materials-68.pdf 62 KB
004662/0000/m3/32-body-data/32s-drug-sub/ide-cel-all/32s2-manuf/control-of-materials-69.pdf 191 KB
004662/0000/m3/32-body-data/32s-drug-sub/ide-cel-all/32s2-manuf/control-of-materials-70.pdf 60 KB
004662/0000/m3/32-body-data/32s-drug-sub/ide-cel-all/32s2-manuf/control-of-materials-71.pdf 185 KB
004662/0000/m3/32-body-data/32s-drug-sub/ide-cel-all/32s2-manuf/control-of-materials-72.pdf 142 KB
004662/0000/m3/32-body-data/32s-drug-sub/ide-cel-all/32s2-manuf/control-of-materials-73.pdf 101 KB
004662/0000/m3/32-body-data/32s-drug-sub/ide-cel-all/32s2-manuf/control-of-materials-74.pdf 66 KB
004662/0000/m3/32-body-data/32s-drug-sub/ide-cel-all/32s2-manuf/control-of-materials-75.pdf 77 KB
004662/0000/m3/32-body-data/32s-drug-sub/ide-cel-all/32s2-manuf/control-of-materials-76.pdf 106 KB
004662/0000/m3/32-body-data/32s-drug-sub/ide-cel-all/32s2-manuf/control-of-materials-77.pdf 64 KB
004662/0000/m3/32-body-data/32s-drug-sub/ide-cel-all/32s2-manuf/control-of-materials-78.pdf 55 KB
004662/0000/m3/32-body-data/32s-drug-sub/ide-cel-all/32s2-manuf/control-of-materials-79.pdf 52 KB
004662/0000/m3/32-body-data/32s-drug-sub/ide-cel-all/32s2-manuf/control-of-materials-80.pdf 50 KB
004662/0000/m3/32-body-data/32s-drug-sub/ide-cel-all/32s2-manuf/control-of-materials-81.pdf 61 KB
004662/0000/m3/32-body-data/32s-drug-sub/ide-cel-all/32s2-manuf/control-of-materials-82.pdf 50 KB
004662/0000/m3/32-body-data/32s-drug-sub/ide-cel-all/32s2-manuf/control-of-materials-83.pdf 48 KB
004662/0000/m3/32-body-data/32s-drug-sub/ide-cel-all/32s2-manuf/control-of-materials-84.pdf 54 KB
004662/0000/m3/32-body-data/32s-drug-sub/ide-cel-all/32s2-manuf/control-of-materials-85.pdf 70 KB
004662/0000/m3/32-body-data/32s-drug-sub/ide-cel-all/32s2-manuf/control-of-materials-86.pdf 81 KB
004662/0000/m3/32-body-data/32s-drug-sub/ide-cel-all/32s2-manuf/control-of-materials-87.pdf 70 KB
004662/0000/m3/32-body-data/32s-drug-sub/ide-cel-all/32s2-manuf/control-of-materials-88.pdf 55 KB
004662/0000/m3/32-body-data/32s-drug-sub/ide-cel-all/32s2-manuf/control-of-materials-89.pdf 63 KB
004662/0000/m3/32-body-data/32s-drug-sub/ide-cel-all/32s2-manuf/control-of-materials-90.pdf 51 KB
004662/0000/m3/32-body-data/32s-drug-sub/ide-cel-all/32s2-manuf/control-of-materials-91.pdf 1019 KB
004662/0000/m3/32-body-data/32s-drug-sub/ide-cel-all/32s2-manuf/control-of-materials-92.pdf 368 KB
004662/0000/m3/32-body-data/32s-drug-sub/ide-cel-all/32s2-manuf/control-of-materials-93.pdf 538 KB
004662/0000/m3/32-body-data/32s-drug-sub/ide-cel-all/32s2-manuf/control-of-materials-94.pdf 69 KB
004662/0000/m3/32-body-data/32s-drug-sub/ide-cel-all/32s2-manuf/control-of-materials-95.pdf 181 KB
004662/0000/m3/32-body-data/32s-drug-sub/ide-cel-all/32s2-manuf/control-of-materials-leuk.pdf 91 KB
004662/0000/m3/32-body-data/32s-drug-sub/ide-cel-all/32s2-manuf/control-of-materials-inert.pdf 73 KB
004662/0000/m3/32-body-data/32s-drug-sub/ide-cel-all/32s2-manuf/control-critical-steps.pdf 106 KB
004662/0000/m3/32-body-data/32s-drug-sub/ide-cel-all/32s2-manuf/process-validation.pdf 81 KB
004662/0000/m3/32-body-data/32s-drug-sub/ide-cel-all/32s2-manuf/process-validation-ppq-s12-suite2.pdf 1 MB
004662/0000/m3/32-body-data/32s-drug-sub/ide-cel-all/32s2-manuf/process-validation-ppq-extended.pdf 139 KB
004662/0000/m3/32-body-data/32s-drug-sub/ide-cel-all/32s2-manuf/process-validation-ppq-s12-suite1.pdf 942 KB
004662/0000/m3/32-body-data/32s-drug-sub/ide-cel-all/32s2-manuf/process-validation-ppq-cellex.pdf 754 KB
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