From discovery to delivery, Mofitt's Cell Therapy and Gene Engineering Facility has partnered with biotech leaders for over 15 years, advancing breakthroughs in cancer care. With 30+ federally funded projects and cutting-edge manufacturing capabilities, we’re accelerating the next wave of cell therapies.
Hear from our esteemed panel of cell therapy experts from Moffitt Cancer Center and Iovance Biotherapeutics.
Located in Tampa, FL Moffitt’s Cell Therapy and Gene Engineering Facility is a 20,000 square foot multi-product facility with ten ISO7 cGMP-certified clean rooms and a ISO7 cGMP certified modular lab. We are equipped to support cell therapy, viral vectors process development and cGMP manufacturing. The facility features advanced infrastructure for producing cell and gene therapies from pre-clinical stages to phase II clinical trials.
Moffitt's facility has collaborated with industry for more than 15 years to advance therapies and research for cancer and beyond. In addition to active biotech collaborations, manufacturing projects in the Moffitt facility are supported by more than 30 federal and foundation grants awarded to Moffitt faculty.
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20,000
sq ft facility
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10
ISO7 cGMP certified clean rooms
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0, I, II
Supports pre-clinical, phase I and phase II trials
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15+
More than 15 years experience in cell therapy manufacturing
Moffitt's Cell & Gene Engineering Accelerator Webinar
 Xavier Avat Executive Vice President, Chief Business Officer |
 Kumar Karyampudi, PhD Senior Director, Cell Therapies |
 Frederick Locke, MD Chair & Senior Member, BMT and Cellular Immunotherapy |
 Brian Gastman, MD Executive Vice President, Medical Affairs, Iovance |
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45+ Cell Therapies Publications
Moffitt researchers and physician scientists continue to publish ground-breaking thought leadership that lead to even more discoveries in the cell therapy and gene engineering space.
See Current Publications List {link?}
1. Chacon J, Sarnaik A, Chen J, Creasy C, Kale C, Robinson J, Weber J, Hwu P, Pilon-Thomas S, Radvanyi LG. Manipulating the tumor microenvironment ex vivo for enhanced expansion of tumor-infiltrating lymphocytes for adoptive cell therapy. Clin Cancer Res2015 Feb; 21: (3) 611-621 PMID: 25472998. PMCID: PMC4315752. IF: 11.500
2. Nelson N, Xiang S, Zhang X, Gilvary D, Djeu J, Husain K, Malafa M, Vohra N, Pilon-Thomas S, Ghansah T. Murine pancreatic adenocarcinoma reduces Ikaros expression and disrupts T cell homeostasis. PLoS One2015 Jan; 10: (1) e0115546- PMID: 25629611. PMCID: PMC4309586. IF: 3.700
3. Chacon JA, Pilon-Thomas S, Sarnaik AA, Radvanyi LG. Continuous 4-1BB co-stimulatory signals for the optimal expansion of tumor-infiltrating lymphocytes for adoptive T-cell therapy. Oncoimmunology 2013 Sep; 2: (9) e25581- PMID: 24319633. PMCID: PMC3850170. IF: 7.200
4. Radvanyi L, Pilon-Thomas S, Peng W, Sarnaik A, Mulé JJ, Weber J, Hwu P. Antagonist antibodies to PD-1 and B7-H1 (PD-L1) in the treatment of advanced human cancer--letter. Clin Cancer Res 2013 Oct; 19: (19) 5541- PMID: 24048330. PMCID: PMC3823378. IF: 11.500
5. Carbone DP, Gandara DR, Antonia SJ, Zielinski C, Paz-Ares L. Non-Small-Cell Lung Cancer: Role of the Immune System and Potential for Immunotherapy. J Thorac Oncol 2015 Jul; 10: (7) 974-984 PMID: 26134219. PMCID: PMC4618296. IF: 20.400
6. Veerapathran A, Pidala J, Beato F, Betts B, Kim J, Turner JG, Hellerstein MK, Yu XZ, Janssen W, Anasetti C. Human regulatory T cells against minor histocompatibility antigens: ex vivo expansion for prevention of graft-versus-host disease. Blood 2013 Sep; 122: (13) 2251-2261 PMID: 23908471. PMCID: PMC3785121. IF: 20.300
7. Creelan BC, Antonia S, Noyes D, Hunter TB, Simon GR, Bepler G, Williams CC, Tanvetyanon T, Haura EB, Schell MJ, Chiappori A. Phase II trial of a GM-CSF-producing and CD40L-expressing bystander cell line combined with an allogeneic tumor cell-based vaccine for refractory lung adenocarcinoma. J Immunother 2013 Oct; 36: (8) 442-450 PMID: 23994887. PMCID: PMC3846277. IF: 3.900
8. Haarberg KM, Li J, Heinrichs J, Wang D, Liu C, Bronk CC, Kaosaard K, Owyang AM, Holland S, Masuda E, Tso K, Blazar BR, Anasetti C, Beg AA, Yu XZ. Pharmacologic inhibition of PKCα and PKCθ prevents GVHD while preserving GVL activity in mice. Blood 2013 Oct; 122: (14) 2500-2511 PMID: 23908466. PMCID: PMC3790515. IF: 20.300
9. Brahmer J, Reckamp KL, Baas P, Crinò L, Eberhardt WE, Poddubskaya E, Antonia S, Pluzanski A, Vokes EE, Holgado E, Waterhouse D, Ready N, Gainor J, Arén Frontera O, Havel L, Steins M, Garassino MC, Aerts JG, Domine M, Paz-Ares L, Reck M, Baudelet C, Harbison CT, Lestini B, Spigel DR. Nivolumab versus Docetaxel in Advanced Squamous-Cell Non-Small-Cell Lung Cancer. N Engl J Med 2015 Jul; 373: (2) 123-135 PMID: 26028407. PMCID: PMC4681400. IF: 158.500
10. Betts BC, Veerapathran A, Pidala J, Yu XZ, Anasetti C. STAT5 polarization promotes iTregs and suppresses human T-cell alloresponses while preserving CTL capacity. J Leukoc Biol 2014 Feb; 95: (2) 205-213 PMID: 24068731. PMCID: PMC3896660. IF: 5.500
11. Fu J, Wang D, Yu Y, Heinrichs J, Wu Y, Schutt S, Kaosaard K, Liu C, Haarberg K, Bastian D, McDonald DG, Anasetti C, Yu XZ. T-bet is critical for the development of acute graft-versus-host disease through controlling T cell differentiation and function. J Immunol 2015 Jan; 194: (1) 388-397 PMID: 25404360. PMCID: PMC4314960. IF: 4.400
12. Pidala J, Kim J, Alsina M, Ayala E, Betts BC, Fernandez HF, Field T, Jim H, Kharfan-Dabaja MA, Locke FL, Mishra A, Nishihori T, Ochoa-Bayona L, Perez L, Riches M, Anasetti C. Prolonged sirolimus administration after allogeneic hematopoietic cell transplantation is associated with decreased risk for moderate-severe chronic graft-versus-host disease. Haematologica 2015 Jul; 100: (7) 970-977 PMID: 25840599. PMCID: PMC4486232. IF: 10.100
13. Li J, Heinrichs J, Haarberg K, Semple K, Veerapathran A, Liu C, Anasetti C, Yu XZ. HY-Specific Induced Regulatory T Cells Display High Specificity and Efficacy in the Prevention of Acute Graft-versus-Host Disease. J Immunol 2015 Jul; 195: (2) 717-725 PMID: 26048147. PMCID: PMC4491008. IF: 4.400
14. Locke FL, Menges M, Veerapathran A, Coppola D, Gabrilovich D, Anasetti C. Survivin-specific CD4+ T cells are decreased in patients with survivin-positive myeloma. J Immunother Cancer 2015 May; 3: 20- PMID: 25992291. PMCID: PMC4437443. IF: 10.900
15. Betts BC, Sagatys EM, Veerapathran A, Lloyd MC, Beato F, Lawrence HR, Yue B, Kim J, Sebti SM, Anasetti C, Pidala J. CD4+ T cell STAT3 phosphorylation precedes acute GVHD, and subsequent Th17 tissue invasion correlates with GVHD severity and therapeutic response. J Leukoc Biol 2015 Apr; 97: (4) 807-819 PMID: 25663681. PMCID: PMC4370048. IF: 5.500
16. Brentjens RJ, Davila ML, Riviere I, Park J, Wang X, Cowell LG, Bartido S, Stefanski J, Taylor C, Olszewska M, Borquez-Ojeda O, Qu J, Wasielewska T, He Q, Bernal Y, Rijo IV, Hedvat C, Kobos R, Curran K, Steinherz P, Jurcic J, Rosenblat T, Maslak P, Frattini M, Sadelain M. CD19-targeted T cells rapidly induce molecular remissions in adults with chemotherapy-refractory acute lymphoblastic leukemia. Sci Transl Med 2013 Mar; 5: (177) 177ra38- PMID: 23515080. PMCID: PMC3742551. IF: 17.100
17. Brentjens RJ, Rivière I, Park JH, Davila ML, Wang X, Stefanski J, Taylor C, Yeh R, Bartido S, Borquez-Ojeda O, Olszewska M, Bernal Y, Pegram H, Przybylowski M, Hollyman D, Usachenko Y, Pirraglia D, Hosey J, Santos E, Halton E, Maslak P, Scheinberg D, Jurcic J, Heaney M, Heller G, Frattini M, Sadelain M. Safety and persistence of adoptively transferred autologous CD19-targeted T cells in patients with relapsed or chemotherapy refractory B-cell leukemias. Blood 2011 Nov; 118: (18) 4817-4828 PMID: 21849486. PMCID: PMC3208293. IF: 20.300
18. Davila ML, Brentjens R, Wang X, Rivière I, Sadelain M. How do CARs work?: Early insights from recent clinical studies targeting CD19. Oncoimmunology 2012 Dec; 1: (9) 1577-1583 PMID: 23264903. PMCID: PMC3525612. IF: 7.200
19. Davila ML, Kloss CC, Gunset G, Sadelain M. CD19 CAR-targeted T cells induce long-term remission and B Cell Aplasia in an immunocompetent mouse model of B cell acute lymphoblastic leukemia. PLoS One 2013 Oct; 8: (4) e61338- PMID: 23585892. PMCID: PMC3621858. IF: 3.700
20. Davila ML, Brentjens R. Chimeric antigen receptor therapy for chronic lymphocytic leukemia: what are the challenges? Hematol Oncol Clin North Am 2013 Apr; 27: (2) 341-353 PMID: 23561477. PMCID: PMC3615434. IF: 2.400
21. Locke FL, Nishihori T, Alsina M, Kharfan-Dabaja MA. Immunotherapy strategies for multiple myeloma: the present and the future. Immunotherapy 2013 Sep; 5: (9) 1005-1020 PMID: 23998734. PMCID: PMC4905571. IF: 2.800
22. Davila ML, Bouhassira DC, Park JH, Curran KJ, Smith EL, Pegram HJ, Brentjens R. Chimeric antigen receptors for the adoptive T cell therapy of hematologic malignancies. Int J Hematol 2014 Apr; 99: (4) 361-371 PMID: 24311149. PMCID: PMC4684946. IF: 2.490
23. Davila ML, Riviere I, Wang X, Bartido S, Park J, Curran K, Chung SS, Stefanski J, Borquez-Ojeda O, Olszewska M, Qu J, Wasielewska T, He Q, Fink M, Shinglot H, Youssif M, Satter M, Wang Y, Hosey J, Quintanilla H, Halton E, Bernal Y, Bouhassira DC, Arcila ME, Gonen M, Roboz GJ, Maslak P, Douer D, Frattini MG, Giralt S, Sadelain M, Brentjens R. Efficacy and toxicity management of 19-28z CAR T cell therapy in B cell acute lymphoblastic leukemia. Sci Transl Med 2014 Feb; 6: (224) 224ra25- PMID: 24553386. PMCID: PMC4684949. IF: 17.100
24. Rizvi NA, Mazières J, Planchard D, Stinchcombe TE, Dy GK, Antonia SJ, Horn L, Lena H, Minenza E, Mennecier B, Otterson GA, Campos LT, Gandara DR, Levy BP, Nair SG, Zalcman G, Wolf J, Souquet PJ, Baldini E, Cappuzzo F, Chouaid C, Dowlati A, Sanborn R, Lopez-Chavez A, Grohe C, Huber RM, Harbison CT, Baudelet C, Lestini BJ, Ramalingam SS. Activity and safety of nivolumab, an anti-PD-1 immune checkpoint inhibitor, for patients with advanced, refractory squamous non-small-cell lung cancer (CheckMate 063): a phase 2, single-arm trial. Lancet Oncol 2015 Mar; 16: (3) 257-265 PMID: 25704439. PMCID: PMC5726228. IF: 51.100
25. Mullinax JE, Hall M, Prabhakaran S, Weber J, Khushalani N, Eroglu Z, Brohl AS, Markowitz J, Royster E, Richards A, Stark V, Zager JS, Kelley L, Cox C, Sondak VK, Mulé JJ, Pilon-Thomas S, Sarnaik AA. Combination of Ipilimumab and Adoptive Cell Therapy with Tumor-Infiltrating Lymphocytes for Patients with Metastatic Melanoma. Front Oncol 2018 Mar; 8: 44- PMID: 29552542. PMCID: PMC5840208. IF: 4.700
26. Atay C, Kwak T, Lavilla-Alonso S, Donthireddy L, Richards AD, Moberg VE, Pilon-Thomas S, Schell MJ, Messina JL, Rebecca VW, Xiao M, Tan J, Zhang G, Weber JS, Herlyn M, Sarnaik AA, Gabrilovich DI. BRAF Targeting Sensitizes Resistant Melanoma to Cytotoxic T Cells. Clin Cancer Res 2019 May; 25: (9) 2783-2794 PMID: 30765391. PMCID: PMC6497575. IF: 11.500
27. Innamarato P, Kodumudi K, Asby S, Schachner B, Hall M, Mackay A, Wiener D, Beatty M, Nagle L, Creelan BC, Sarnaik AA, Pilon-Thomas S. Reactive Myelopoiesis Triggered by Lymphodepleting Chemotherapy Limits the Efficacy of Adoptive T Cell Therapy. Mol Ther 2020 Oct; 28: (10) 2252-2270 PMID: 32615068. PMCID: PMC7544980. IF: 12.400
28. Perales-Puchalt A, Svoronos N, Rutkowski MR, Allegrezza MJ, Tesone AJ, Payne KK, Wickramasinghe J, Nguyen JM, O'Brien SW, Gumireddy K, Huang Q, Cadungog MG, Connolly DC, Tchou J, Curiel TJ, Conejo-Garcia JR. Follicle-Stimulating Hormone Receptor Is Expressed by Most Ovarian Cancer Subtypes and Is a Safe and Effective Immunotherapeutic Target. Clin Cancer Res 2017 Jan; 23: (2) 441-453 PMID: 27435394. PMCID: PMC5241180. IF: 11.500
29. Hopewell EL, Cox C, Pilon-Thomas S, Kelley LL. Tumor-infiltrating lymphocytes: Streamlining a complex manufacturing process. Cytotherapy 2019 Mar; 21: (3) 307-314 PMID: 30509772. PMCID: PMC6453723. IF: 4.500
30. Shrestha B, Zhang Y, Yu B, Li G, Boucher JC, Beatty NJ, Tsai HC, Wang X, Mishra A, Sweet K, Lancet JE, Kelley L, Davila ML. Generation of Antitumor T Cells For Adoptive Cell Therapy With Artificial Antigen Presenting Cells. J Immunother 2020 Apr; 43: (3) 79-88 PMID: 31834208. PMCID: PMC7077957. IF: 3.900
31. Poch M, Hall M, Joerger A, Kodumudi K, Beatty M, Innamarato PP, Bunch BL, Fishman MN, Zhang J, Sexton WJ, Pow-Sang JM, Gilbert SM, Spiess PE, Dhillon J, Kelley L, Mullinax J, Sarnaik AA, Pilon-Thomas S. Expansion of tumor infiltrating lymphocytes (TIL) from bladder cancer. Oncoimmunology 2018 Jul; 7: (9) e1476816- PMID: 30228944. PMCID: PMC6140546. IF: 7.200
32. Neelapu SS, Tummala S, Kebriaei P, Wierda W, Gutierrez C, Locke FL, Komanduri KV, Lin Y, Jain N, Daver N, Westin J, Gulbis AM, Loghin ME, de Groot JF, Adkins S, Davis SE, Rezvani K, Hwu P, Shpall EJ. Chimeric antigen receptor T-cell therapy - assessment and management of toxicities. Nat Rev Clin Oncol 2018 Jan; 15: (1) 47-62 PMID: 28925994. PMCID: PMC6733403. IF: 66.675
33. Gray JE, Chiappori A, Williams CC, Tanvetyanon T, Haura EB, Creelan BC, Kim J, Boyle TA, Pinder-Schenck M, Khalil F, Altiok S, Devane R, Noyes D, Mediavilla-Varela M, Smilee R, Hopewell EL, Kelley L, Antonia SJ. A phase I/randomized phase II study of GM.CD40L vaccine in combination with CCL21 in patients with advanced lung adenocarcinoma. Cancer Immunol Immun 2018 Dec; 67: (12) 1853-1862 PMID: 30209589. PMCID: PMC6244998. IF: 5.800
34. Wang M, Munoz J, Goy A, Locke FL, Jacobson CA, Hill BT, Timmerman JM, Holmes H, Jaglowski S, Flinn IW, McSweeney PA, Miklos DB, Pagel JM, Kersten MJ, Milpied N, Fung H, Topp MS, Houot R, Beitinjaneh A, Peng W, Zheng L, Rossi JM, Jain RK, Rao AV, Reagan PM. KTE-X19 CAR T-Cell Therapy in Relapsed or Refractory Mantle-Cell Lymphoma. N Engl J Med 2020 Apr; 382: (14) 1331-1342 PMID: 32242358. PMCID: PMC7731441. IF: 158.500
35. Locke FL, Neelapu SS, Bartlett NL, Siddiqi T, Chavez JC, Hosing CM, Ghobadi A, Budde LE, Bot A, Rossi JM, Jiang Y, Xue AX, Elias M, Aycock J, Wiezorek J, Go WY. Phase 1 Results of ZUMA-1: A Multicenter Study of KTE-C19 Anti-CD19 CAR T Cell Therapy in Refractory Aggressive Lymphoma. Mol Ther 2017 Jan; 25: (1) 285-295 PMID: 28129122. PMCID: PMC5363293. IF: 12.400
36. Soliman H, Khambati F, Han HS, Ismail-Khan R, Bui MM, Sullivan DM, Antonia S. A phase-1/2 study of adenovirus-p53 transduced dendritic cell vaccine in combination with indoximod in metastatic solid tumors and invasive breast cancer. Oncotarget 2018 Feb; 9: (11) 10110-10117 PMID: 29515795. PMCID: PMC5839376.
37. Kodumudi KN, Ramamoorthi G, Snyder C, Basu A, Jia Y, Awshah S, Beyer AP, Wiener D, Lam L, Zhang H, Greene MI, Costa RLB, Czerniecki BJ. Sequential Anti-PD1 Therapy Following Dendritic Cell Vaccination Improves Survival in a HER2 Mammary Carcinoma Model and Identifies a Critical Role for CD4 T Cells in Mediating the Response. Front Immunol 2019 Aug; 10: 1939- PMID: 31475002. PMCID: PMC6702967. IF: 7.300
38. Creelan BC, Wang C, Teer JK, Toloza EM, Yao J, Kim S, Landin AM, Mullinax JE, Saller JJ, Saltos AN, Noyes DR, Montoya LB, Curry W, Pilon-Thomas SA, Chiappori AA, Tanvetyanon T, Kaye FJ, Thompson ZJ, Yoder SJ, Fang B, Koomen JM, Sarnaik AA, Chen DT, Conejo-Garcia JR, Haura EB, Antonia SJ. Tumor-infiltrating lymphocyte treatment for anti-PD-1-resistant metastatic lung cancer: a phase 1 trial. Nat Med 2021 Aug; 27: (8) 1410-1418 PMID: 34385708. PMCID: PMC8509078. IF: 82.900
39. Frank MJ, Hossain NM, Bukhari A, Dean E, Spiegel JY, Claire GK, Kirsch I, Jacob AP, Mullins CD, Lee LW, Kong KA, Craig J, Mackall CL, Rapoport AP, Jain MD, Dahiya S, Locke FL, Miklos DB. Monitoring of Circulating Tumor DNA Improves Early Relapse Detection After Axicabtagene Ciloleucel Infusion in Large B-Cell Lymphoma: Results of a Prospective Multi-Institutional Trial. J Clin Oncol 2021 Sep; 39: (27) 3034-3043 PMID: 34133196. IF: 45.400
40. Sarnaik AA, Hamid O, Khushalani NI, Lewis KD, Medina T, Kluger HM, Thomas SS, Domingo-Musibay E, Pavlick AC, Whitman ED, Martin-Algarra S, Corrie P, Curti BD, Oláh J, Lutzky J, Weber JS, Larkin JMG, Shi W, Takamura T, Jagasia M, Qin H, Wu X, Chartier C, Graf Finckenstein F, Fardis M, Kirkwood JM, Chesney JA. Lifileucel, a Tumor-Infiltrating Lymphocyte Therapy, in Metastatic Melanoma. J Clin Oncol 2021 Aug; 39: (24) 2656-2666 PMID: 33979178. PMCID: PMC8376325. IF: 45.400
41. Jain MD, Ziccheddu B, Coughlin CA, Faramand RG, Griswold AJ, Reid KM, Menges M, Zhang Y, Cen L, Wang X, Hussaini MO, Landgren O, Davila ML, Schatz JH, Locke FL, Maura F. Whole-genome sequencing reveals complex genomic features underlying anti-CD19 CAR T-cell treatment failures in lymphoma. Blood 2022 Aug; 140: (5) 491-503 PMID: 35476848. PMCID: PMC9353150. IF: 20.300
42. Innamarato P, Asby S, Morse J, Mackay A, Hall M, Kidd S, Nagle L, Sarnaik AA, Pilon-Thomas S. Intratumoral Activation of 41BB Costimulatory Signals Enhances CD8 T Cell Expansion and Modulates Tumor-Infiltrating Myeloid Cells. J Immunol 2020 Nov; 205: (10) 2893-2904 PMID: 33020146. PMCID: PMC7741883. IF: 4.400
43. Mullinax JE, Hall M, Beatty M, Weber AM, Sannasardo Z, Svrdlin T, Hensel J, Richards A, Gonzalez RJ, Cox CA, Kelley L, Mulé JJ, Sarnaik AA, Pilon-Thomas S. Expanded Tumor-infiltrating Lymphocytes From Soft Tissue Sarcoma Have Tumor-specific Function. J Immunother 2021 Feb; 44: (2) 63-70 PMID: 33443972. PMCID: PMC8111686. IF: 3.900
44. Hall MS, Mullinax JE, Cox CA, Hall AM, Beatty MS, Blauvelt J, Innamarato P, Nagle L, Branthoover H, Wiener D, Schachner B, Martinez AJ, Richards AD, Rich CJ, Colón Colón M, Schell MJ, Teer JK, Khushalani NI, Weber JS, Mule JJ, Sondak VK, Pilon-Thomas S, Sarnaik AA. Combination Nivolumab, CD137 Agonism, and Adoptive Cell Therapy with Tumor-Infiltrating Lymphocytes for Patients with Metastatic Melanoma. Clin Cancer Res 2022 Dec; 28: (24) 5317-5329 PMID: 36215121. PMCID: PMC10324027. IF: 11.500
45. Boucher JC, Yu B, Li G, Shrestha B, Sallman D, Landin AM, Cox C, Karyampudi K, Anasetti C, Davila ML, Bejanyan N. Large Scale Ex Vivo Expansion of γδ T cells Using Artificial Antigen-presenting Cells. J Immunother 2023 Jan; 46: (1) 5-13 PMID: 36378147. PMCID: PMC9722378. IF: 3.900
Expertise Across the Lifecycle of Cell Therapy Production
Launched in 2006, Moffitt's facility offers comprehensive experience across a range of cell types, viral vectors, techniques and assays. Our decades of expertise in the product development and cGMP manufacturing supports accelerated IND filing, support for CMC preparation and faster turnaround for clinical trial amendments.
A PACT site
Moffitt was selected as a Cell Processing Facility offering translational services and cell product manufacturing for pre-clinical studies to investigators at no charge under the National Heart, Lung, and Blood Institute-funded Production Assistance for Cellular Therapies (PACT) program.
Manufacturing Expertise
Moffitt’s cell manufacuring team, in collaboration with Moffitt faculty and industry-expert leadership, have diverse experience in developing and optimizing a wide range of cell therapy assets, including:
- Autologous and “off-the-shelf” allogeneic CAR-T therapies for heme malignancies
- CAR-T, Tregs, and gdT cells therapy for solid tumors
- TCR-T therapies for solid tumors
- TIL therapies for solid tumors
- NKs and CAR-NKs therapies
- Dendritic cell vaccines
- Hemopoietic stem cell therapies
Our strong focus in translating compelling laboratory research into the clinic enables our partners to embark on clinical trials with their cell therapy assets with the potential for FDA approval upon clinical validation.
20+
Experimental Cell Therapy INDs Currently in Manufacturing
Moffitt currently supports the manufacturing for 20+ different experimental cell therapy INDs and played a pivotal clinical translational role in the recent approval of AMTAGVI, a commercial TIL product from Iovance.
Regulatory Support
Moffitt's regulatory team within the Cell Therapy Facility accelerates the time-to-market for cell therapies, anticipating FDA requirements and providing support for IND applications to minimize clinic entry time.
We support chemistry, manufacturing, and controls (CMC) submissions for cell therapy products and provide guidance on testing requirements, anticipating regulatory and documentation needs from the FDA.
The Moffitt team has successfully secured various FDA designations for partners, including:
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- Breakthrough Therapy Designation
- Priority Review
- Accelerated Approval
- Fast Track Designation
- Orphan Drug Designation
- Biologics License Applications (BLA)
- Regenerative Medicine Advanced Therapy (RMAT)
Cell Therapy & Gene Engineering Services
Scientific rigor, patient focus, regulatory support expertise and operational excellence are four key areas of expertise that makes this facility an excellent choice for the development and manufacturing of cell and gene therapy products.
New Product Development
New Product DevelopmentFrom concept to clinical trials, we provide comprehensive support for pre-clinical scale-up, testing, and validation.
Analytical Labratory
Analytical LabratoryDual-function laboratory for product quality testing and post-treatment immune monitoring.
Cell Collection & Cryostorage
Cell Collection & CryostorageSecure, efficient collection and storage of mononuclear cells, lymphocytes, and antigen-presenting cells.
Hematopoietic Stem Cell Processing
Hematopoietic Stem Cell ProcessingProcessing and purification of leukapheresis material, handling of commercial cellular products.
Cell & Vector Products Manufacturing
Cell & Vector Products ManufacturingExpert manufacturing of tumor infiltrating lymphocytes, genetically engineered immune cells, dendritic/tumor cell-based vaccines and viral vector products.
Moffitt Plays Pivotal Role in FDA Approval of Tumor-Infiltrating Lymphocyte Therapy for Advanced Melanoma
A first-of-its-kind cellular immunotherapy pioneered at Moffitt Cancer Center has received approval from the Food and Drug Administration and is now available for patients with advanced melanoma. Lifileucel is the first tumor-infiltrating lymphocyte therapy, or TIL, approved for solid tumors.
Moffitt Patient is First-in-the-World to Receive Tecelra Gene Therapy Following FDA Approval
Moffitt's Cell Therapy Facility was intrumental in getting this synovial sarcoma patient access to the gene therapy Tecelra. Administered on Thanksgiving Day, Moffitt researchers, physician scientists and gene therapy manufacturing teams come together to provide hope for patients.
Interested in working with Moffitt's Cell Therapy Facility?
Meet the Management Team
Moffitt's comprehensive team in Tampa, FL is ready to support the development of life-saving cell and gene therapies for our community and throughout the world.
Fabiana Perna, MD, PhD
Medical Director
Daniel Abate-Daga, PhD
Scientific Director
Danielle Steele, MS
Manager Cell Therapy Core Viral Vector Production
Albert Ribickas, MT(ASCP)HP,SBB
Manager Cell Therapies Core Operations
Alberto van Olphen, PhD
Facilities and Operations Manager
Melba Marie Page, PhD
Quality Control Manager
Tiffany Clement, MBA
Inventory Management and Support Services Manager
Ashley Goss, M. Sc.
Quality Management Manager
Shelby McNemar, MS
Experimental Cell Therapies Manager
Jennifer Adamo, BS, MLS
Bone Marrow Transplant Supervisor
Aaron Torbert
Bone Marrow Transplant Supervisor
Alberto (Jay) Martinez, MHA
Patient Product Handling Supervisor
Oriana Borquez-Ojeda, MS
Experimental Cell Therapy Supervisor
Alexander Dojcinovski
Experimental Cell Therapy Supervisor
Christopher Mosychuk, CABP
Experimental Cell Therapy Supervisor
Christopher Arnemann, M. Sc.
Quality Management Supervisor
Contact Us
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