Process Development & Manufacturing Personnel
Remembering Neehar Bhatia, Ph.D. Senior Director
Neehar was the Senior Director of CDCM Process Development and Manufacturing at the Laboratory of Cell and Gene Medicine (LCGM), Stanford University. Dr. Bhatia received a Ph.D. in Biochemistry from the Central Drug Research Institute, India. Dr. Bhatia was responsible for development and manufacturing of cGMP compliant cell and gene therapy products at LCGM. Dr. Bhatia oversaw manufacturing for multiple projects such as CD19/CD22 bi-specific CAR-T and other T cell based therapies, CD34 HSPC transplant and manufacturing of AAV6 for gene correction in HSPC. Dr. Bhatia lead multiple projects which include banking of ESCs, iPSCs, MSCs and iPSC derived differentiated cells, development of GMP process for translational projects and manufacturing cell therapies for Phase I/II clinical trials. Dr. Bhatia also lead efforts in quest for serum-free chemically defined culture medium for MSCs and development of platform technology for AAV production. Dr. Bhatia’s focus was on development of cGMP compliant manufacturing process for “bench to bedside” cell and gene therapies.
David M Gamm, Neehar Bhatia, Anna Petelinsek, Jee Min, Elizabeth E Capowski, Travis Cordie, Diana Drier, Connor Lyons, Derek Hei, Joe Phillips. (2015) cGMP production of neural retina from hiPSCs. ARVO Annual Meeting Abstract. Investigative Ophthalmology & Visual Science June 2015, Vol.56, 3170.
Bloom DD, Centanni JM, Bhatia N, Emler CA, Drier D, Leverson GE, McKenna DH Jr, Gee AP, Lindblad R, Hei DJ, Hematti P. (2015) A reproducible immunopotency assay to measure mesenchymal stromal cell-mediated T-cell suppression. Cytotherapy. 17(2): 140-51.
Neehar Bhatia, Tony Z. Xiao, Kimberly A. Rosenthal, Imtiaz A. Siddiqui, Saravanan Thiyagarajan, B. Smart, Qiao Meng, C.L. Zuleger, Hasan Mukhtar, Shannon C. Kenney, Mark. R. Albertini and B. Jack Longley. (2013) MAGE-C2 promotes growth and tumorigenicity of melanoma cells, phosphorylation of KAP-1, and DNA damage repair. J. Invest. Dermatol. 133(3):759-67.
Neehar Bhatia, Tara A. Demmer and Vladimir Spiegelman. (2008) Inhibition of β-TrCP function potentiates UVB-induced apoptosis in hTERT-immortalized normal human keratinocytes. Photochemistry and Photobiology, 84(2): 376-381.
Felicite K. Noubissi, Irina Elcheva, Neehar Bhatia, Andrei Ougolkov, Toshinari Minamoto, Jeff Ross, Serge Y. Fuchs, and Vladimir S. Spiegelman.(2006) CRD-BP mediates stabilization of β-TrCP, and c-myc mRNA in response to β-catenin signaling. Nature, 441(7095): 898-901.
Neehar Bhatia, SaravananThiyagarajan, Irina Elcheva, Mohammed Saleem, Andrzej Dlugosz, Hasan Mukhtar, and Vladimir S. Spiegelman.(2006) Gli2 is targeted for ubiquitination and degradation by β–TrCP ubiquitin ligase. Journal of Biological Chemistry, 281(28): 19320-19326
Cancer Cell Therapy (CCT) Team
Steven Feldman, PhD
Steven Feldman, Ph.D. is the Director of Process Development and Manufacturing for the Mackall Lab at the Center for Cancer Cell Therapy and Laboratory of Cell and Gene Medicine (LCGM), Stanford University.
Annie is a manufacturing specialist at the Center for Cancer Cell Therapy and Laboratory for Cell and Gene Medicine (LCGM). She earned her MS in Bioengineering from Santa Clara University, where she worked on projects modifying and harvesting extracellular vesicles (EVs) from mammalian cells. Annie is excited to be part of a team manufacturing cancer cell therapies that go directly to the clinic.
CMC Operations Manager
Bio coming soon
Sunny joins the CCT PDM team with a B.A. in Biology and History from the University of North Carolina at Chapel Hill. He has gained cGMP experience working at Merck in Durham, NC and at the Dana Farber Cancer Institute in Boston, MA, while also gaining experience in Process Development at TScan Therapeutics. Sunny is thrilled to join the brilliant staff at LCGM and to help in any way the manufacturing and production of Phase I/II CAR-T clinical trials.
Shabnum Patel, PhD
Shabnum earned her Ph.D in Immunology & Microbiology at George Washington University. She is the Associate Director of Process Development and Manufacturing for the Mackall Lab at the Center for Cancer Cell Therapy and Laboratory of Cell and Gene Medicine (LCGM), Stanford University.
Brian Hoang earned his B.S. in Bioengineering from the University of California, Merced. Working at Genentech in South San Francisco and Miltenyi Biotec in San Jose, Brian gained the hands-on cGMP experience in T-cell therapy and contributed to the manufacturing and process development of T-Cells and other cell therapies while operating the CliniMACS Prodigy.
At LCGM, Brian is responsible for manufacturing and production of CAR-T cells for Phase I/II clinical trials at the Stanford Cancer Institute. Joining Stanford University in February 2021, Brian is excited to help the Center for Cancer Cell Therapy (CCT) and LCGM as a Process Development and Manufacturing Specialist II and is willing to contribute to the team in any way that he can.
Kyle earned his B.S. in Mechanical Engineering from Santa Clara University where he, alongside a minor in Bioengineering, did research into the mechanics of modifying exosomes (extracellular vesicles) for use in drug delivery to the brain. He is eager to contribute to, and learn from, all of LCGM.
Center for Definitive & Curative Medicine (CDCM) Team
Senior PDM Scientist
Prachi earned her Master of Science in Biotechnology from San Jose State University in 2010 and another Master of Science in Public Health from India in 2007. She has more than 10 years of combined academic and industry experience in the areas of stem cell biology, translational research, oncology and molecular biology. Prachi has been part of Institute for Stem Cell and Regenerative Medicine at Stanford University for about 7 years. During her time at Stanford, she has had extensive experience in human disease modeling and cell therapy projects from concept to development for multiple disorders like Parkinson’s disease and Pelvic Floor disorder. Prachi has also led multiple projects which include generating and banking of iPSCs, ESCs and iPSC derived cell products.
At LCGM, Prachi is responsible for supporting development and optimization of cGMP compliant processes for manufacturing of various cell therapies according to regulatory guidelines.
Yanhui Li, Morgaine Green, Yan Wen, Yi Wei, Prachi Wani, Zhe Wang, Renee Reijo Pera, Bertha Chen. Efficacy and Safety of Immuno-Magnetically Sorted Smooth Muscle Progenitor Cells Derived from Human-Induced Pluripotent Stem Cells for Restoring Urethral Sphincter Function. Stem Cells Transl Med. 2017 Apr; 6(4):1158-1167.
Yanhui Li, Yan Wen, Zhe Wang, Yi Wei, Prachi Wani, Morgaine Green, Ganesh Swaminathan, Anand Ramamurthi, Renee Reijo Pera, Bertha Chen. Smooth Muscle Progenitor Cells Derived from Human Pluripotent Stem Cells Induce Histologic Changes in Injured Urethral Sphincter. Stem Cells Transl Med. 2016 Dec; 5(12):1719-1729.
Zhe Wang, Yan Wen, Yan Hui Li, Yi Wei, Morgaine Green, Prachi Wani, Pengbo Zhang, Renee Reijo Pera, Bertha Chen. Smooth Muscle Precursor Cells Derived from Human Pluripotent Stem Cells for Treatment of Stress Urinary Incontinence. Stem Cells Dev. 2016 Mar 15; 25(6):453-61.
Yan Wen, Prachi Wani, Lu Zhou, Tom Baer, Smruti Phadnis, Renee Reijo Pera, Bertha Chen. Reprogramming of Fibroblasts from Older Women with Pelvic Floor Disorders Alters Cellular Behavior Associated with Donor Age. Stem Cells Transl Med. 2013 Feb; 2(2):118-28.
Ha Nam Nguyen, Blake Byers, Branden Cord, Aleksandr Shcheglovitov, James Byrne, Prachi Gujar, Kehkooi Kee, Birgitt Schüle, Ricardo E. Dolmetsch, William Langston Theo D. Palmer, Renee Reijo Pera. LRRK2 Mutant iPSC-Derived DA Neurons Demonstrate Increased Susceptibility to Oxidative Stress. Cell Stem Cell. 2011 Mar 4; 8(3):267-80.
Catherine received her B.A. in Cell & Molecular Biology from Occidental College in May 2020.
While at Occidental, she researched vaccination strategies for the equine disease Pigeon Fever and received distinction for her senior comprehensive project on the epigenetic regulation of primitive and definitive hematopoiesis.
She joins LCGM in September 2020 and is excited to be a part of the team that helps bring innovative cellular therapies to patients.
Vimal joins us from Sorrento Therapeutics, San Diego where he worked as a Process Development Associate II, optimizing manufacturing of autologous Anti CD38 and Anti CEA CAR-T products. Prior to that he worked on developing macrophage immunotherapy strategies at the Sanford Consortium for Regenerative Medicine of UC San Diego. He graduated from the University of California at Riverside in 2017 with a MS Biochemistry and Molecular Biology. He is part of the Clinical Process Development and Manufacturing team at the Laboratory of Cell and Gene Medicine, Stanford School of Medicine.
Manufacturing Specialist II
James Dinh earned his B.S. in Biological Sciences with a concentration in Systems Physiology and a minor in Chemistry from San Jose State University in May 2017. Working at Genentech in South San Francisco and Miltenyi Biotec in Sunnyvale/San Jose, James gained the hands-on cGMP experience in Mammalian Cell Culture within the BSC and contributed to the manufacturing and process development of T-Cells and other cell therapies while operating the CliniMACS Prodigy on a regular basis. In addition, James formulated these final cell products and shipped them out to directly to clientele.
At LCGM, James will be responsible for manufacturing TCR ab+ T cells/CD19+ B cell depletion therapies and for production of T regulatory type 1 cells for cellular infusions. Joining Stanford University in November 2020, James is proud to help the LCGM team as a Process Development and Manufacturing Specialist II and is willing to contribute to the cellular therapies in any way that he can.
Tim Van Horn
Tim received his B.S. in Biological Sciences with a concentration in Biotechnology from California State University, Bakersfield in 2019. While earning his B.S., Tim was a Division I track and field athlete specializing in the high jump as well as a biology and chemistry tutor. Tim then went to work for Genentech in Vacaville as a Manufacturing Bioprocess Technician where he developed his cGMP experience producing Perjeta™ and Actemra™.
At LCGM, Tim will be responsible for TCR ab+ T cells/ CD19+ B cell depletion therapies. Joining Stanford in March 2021, Tim is excited to be a part of the LCGM team as a Process Development and Manufacturing Associate and is looking forward to helping patients in need.
Girija Vasudevan graduated from CSU Channel Islands with an M.S in Biotechnology and Bioinformatics. She also won a CIRM scholarship and was accepted into the Stem Cell Emphasis. She worked on the negative effect of electronic cigarette fluid from different Vuse products on human embryonic development using human embryonic stem cells (hESC) as a model at U C Riverside. Upon graduation, she worked as a Post Graduate Associate at Yale School of medicine. She has worked on multiple diverse projects and used several other cell types for her research works.
Girija is a Process Development and manufacturing specialist II. She is responsible for TCR ab+ T cells/CD19+ B cell depletion therapies. She is very excited to be part of the CDCM team, contribute readily to the team any way she can.
Keri Marie Tate, PhD
Keri earned her Ph.D in Immunology, studying antigen processing and presentation of self-proteins, from the Université de Paris VII, Paris, France. She studied the in vitro and in vivo influence of MHC class II polymorphism on the immune response during her post-doctoral research at Stanford University. While working in biotechnology she developed antigen-specific T cells for testing potency of peptide-MHC complexes and created a panel of novel monoclonal antibodies specific for shared epitopes of human immunoglobulin variable regions for the treatment of B cell-derived malignancies. Keri joined the Cell Therapy Facility at Stanford Health Care, Division of Blood and Marrow Transplant in 2010 where she has been doing process development and manufacturing of cell therapies for IND managed trials.
Publications and patents:
Christopher Lee, Michael N. Liang, Keri M. Tate, Joshua D. Rabinowitz, Craig Beeson, Patricia P. Jones, and Harden M. McConnell. Evidence that the Autoimmune Antigen Myelin Basic Protein (MBP) Ac1-9 binds towards one end of the Major Histocompatibility complex (MHC) Cleft. J. Exp. Med. 187:1505 (1998).
McCutcheon M, Wehner N, Wensky A, Kushner M, Doan S, Hsiao L, Calabresi P, Ha T, Tran TV, Tate KM, Winkelhake J, Spack EG. A sensitive ELISPOT assay to detect low-frequency human T lymphocytes. J. Immunological Methods. 210:149 (1997).
PATENT: Denney, Dan W., Keri Marie Tate, Theriault, Thomas P. Combination Therapy and Antibody Panels. Publication No. CA2632744 A1, Publication Date: 14.JUN2007, International Application No. PCT/US2006/047077, International Filing Date: 08DEC2006
Saar Gill, Adrianne E. Vasey, Alysha De Souza, Jeanette Baker, Aaron T. Smith, Holbrook E. Kohrt, Mareike Florek, Kenneth D. Gibbs, Jr., Keri Tate, David Ritchie and Robert S. Negrin. Rapid development of exhaustion and downregulation of eomesodermin limits the anti-tumor activity of adoptively transferred murine natural killer cells. Blood 119:5758 (2012).
Senior Manufacturing Specialist
Jason Skowronski received his B.S. in Pharmacology at the University of California – Santa Barbara and joined the Laboratory for Cell and Gene Medicine in September 2018, as a Clinical Process Development & Manufacturing Professional. At LCGM, Jason is responsible for manufacturing CD19/CD22 bi-specific CAR-T cell therapies and for production of CD34+ Hematopoietic Stem Cells and gene corrected cells using CRISPR/Cas9.
Degree: B.S. in Biological Scienes with concentration in Systems Physiology. Minor in Chemistry and a Minor in Mathematics.
University: San Jose State University
Dana has several years of experience working in Mammalian Cell Culture since her graduation from San Jose State University. She's worked in both a GMP setting and an R&D setting and understands that cell culturing, particularly mammalian cells can be a very delicate process. Dana is proud to be a part of the LCGM team to help further the process development and the clinical trails that are performed at the LCGM facility.
Jamie Lunkley, Ngoc Nguyen, Kristina Tuminaro, Dana Margittai, and Gilles Muller. "The Importance of Solvent Effects on the Mechanism of the Pfeiffer Effect" Inorganics (2018).
Arpit received his first Master of science in Microbial Biotechnology from Panjab University, India in 2014. He received his second Master of Science in Biotechnology and Bioinformatics from CSU Channel Islands in 2018. During the Master’s program, he won the CIRM scholarship and worked on the CFTR Gene correction in upper airway stem cells as CIRM bridges intern at Stanford University's Department of Hematology.
He joined the Clinical Process Development and Manufacturing team at the Stanford Laboratory of Cell and Gene Medicine in March, 2020. Prior to his transition at Stanford LCGM, Arpit worked as an Life Science Research Professional in the Department of Hematology. During his stay, he was part of the team working on modeling of Celiac Disease in stem cell organoids.
Vaidyanathan, Sriram, Salahudeen Ameen, Sellers Zachary, Bravo Dawn, Choi Shannon, Batish Arpit et.al. “High-Efficiency, Selection-Free Gene Repair in Airway Stem Cells from Cystic Fibrosis Patients Rescues CFTR Function in Differentiated Epithelia.” Cell Stem Cell, 2019, doi:10.1016/j.stem.2019.11.002.
Lobos J, Batish A, Sharma A, Tawil B “Home- Grown Kidneys: Challenges and Mechnasims behind Tissue Engineering for the Treatment of Chronic Kidney Disease”. J Appl Biotehnol Bioeng, 2017, 2(3): 00029. DOI: 10.154.6/jab.2017.02.00029
Ameen A. Salahudeen, Shannon S. Choi, Arjun Rustagi, Junjie Zhu, Sean M. de la O, Ryan A. Flynn, Mar Margalef-Català, António J. M. Santos, Jihang Ju, Arpit Batish, Vincent van Unen, Tatsuya Usui, Grace X.Y. Zheng, Caitlin E. Edwards, Lisa E. Wagar, Vincent Luca, Benedict Anchang, Monica Nagendran, Khanh Nguyen, Daniel J. Hart, Jessica M. Terry, Phillip Belgrader, Solongo B. Ziraldo, Tarjei S. Mikkelsen, Pehr B. Harbury, Jeffrey S. Glenn, K. Christopher Garcia, Mark M. Davis, Ralph S. Baric, Chiara Sabatti, Manuel R. Amieva, Catherine A. Blish, Tushar J. Desai, Calvin J. Kuo ‘Progenitor identification and SARS-CoV-2 infection in long-term human distal lung organoid cultures’ doi: https://doi.org/10.1101/2020.07.27.212076
Kevin received his B.A. in Biology at San Jose State University where we worked alongside his professor to study species differentiation among native moss species.
Since then, He explored different career paths and found himself working at Genentech in South San Francisco manufacturing Herceptin, Activase, and Pulmozyme. He started in stock solutions and eventually moved into commercial bulk, filling, and inspection. Later he received extensive training in mammalian cell culture and drug purification.