Process Development & Manufacturing Personnel

Neehar Bhatia, PhD

Director of Process Development & Manufacturing

Neehar Bhatia, Ph.D. is Associate Director of Process Development and Manufacturing at 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 is responsible for development and manufacturing of cGMP compliant cell and gene therapy products at LCGM. Dr. Bhatia oversees 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 has 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 has 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 is on development of cGMP compliant manufacturing process for “bench to bedside” cell and gene therapies.

Selected Publications:

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

 

Prachi Wani

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.

 

Publications:

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 ZhouTom Baer, Smruti PhadnisRenee 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.

Vignesh Nadar

PDM Scientist

Vignesh was a CIRM bridges to Stem Cell Research fellow at UC Santa Barbara and worked on projects investigating the role of functional pathways in differentiation of iPSC's and hESC's into retinal pigment epithelium during his Masters. His industry experience include working as an iPSC Research Associate at The New York Stem Cell Foundation (NYSCF) where he coordinated the day to day activities of the NYSCF Global Stem Cell Array which specialized in scale out production of induced pluripotent stem (iPS) cells.

Prior to his transition at Stanford LCGM, Vignesh led investigations for differentiation of retinal organoids and ganglion cells from pluripotent stem cells at UC Santa Barbara and worked as a Product Development Associate for Regenerative Patch Technologies.

His areas of interest include pluripotent stem cell therapies and advancing translational medicine.

Educational Background:

  • M.S. - Stem Cell Biology - California State University Channel Islands
  • M.Sc. - Bioinformatics - Mumbai University
  • B.Sc. - Chemistry - Mumbai University

Publications:

Canonical/β-catenin Wnt pathway activation improves retinal pigmented epithelium derivation from human embryonic stem cells

Leach L, Buchholz D, Nadar V, Lowenstein S, Clegg D

Investigative Ophthalmology and Visual Science (2015) 56(2) 1002-1013

Induced Pluripotent Stem Cell-Derived Retinal Pigmented Epithelium: A Comparative Study Between Cell Lines and Differentiation Methods

Leach L, Croze R, Hu Q, Nadar V, Clevenger T, Pennington B, Gamm D, Clegg D

Journal of Ocular Pharmacology and Therapeutics (2016) 32(5) jop.2016.0022

Michael Lebwohl

PDM Assistant

Michael graduated from Yale University with a BA in Chemistry, with senior research on soil enzymes and their impact on nutrient cycling and greenhouse emissions. He has worked previously in nonprofit administration, education, policy research, and political organizing.

Michael joined LCGM in 2020, and proudly supports the Process Development and Manufacturing staff as they bring cutting-edge therapies from Stanford laboratories to patient bedsides.

Arpit Batish

PDM Scientist

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.

Publications:

·       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

Keri Marie Tate, PhD

Senior PD Scientist

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).

Premanjali Lahir

Senior PD Scientist

Premanjali Lahiri received her Master of Science in Biotechnology from Texas A&M University in 2013. During her time at Texas A&M, she worked at the Institute for Applied Cancer Sciences at the MD Anderson Cancer Center where she developed assays for screening small molecules for breast and ovarian cancers. Premanjali has had  extensive experience with developing and manufacturing human cell and tissue products (HCT/P) while she was working with mesenchymal stem cells(MSCs) at Celltex Therapeutics in Houston,TX where she was the manufacturing manager and oversaw the day to day cell manufacturing activities in their GMP compliant facilities. Her interests include developing and optimizing scalable processes for the clinical manufacture of cell and gene therapy products for cancer and non-cancer immunotherapies across diverse regulatory environments.

 

 

Nidhi Shah

Senior Manufacturing Specialist

Nidhi received her BS and MS in Biochemistry from Iowa State University (ISU). She earned another MS in Nutritional Sciences from ISU. She has research experience in conducting human, animal, cell culture and biochemical studies along with Dr. richard Honzatko and Dr. Suzanne Hendrich. At the LCGM, she is a Manufacturing Specialist and she makes cellular therapeutic products for clinical trials. 

Publications

Shah, N, "Effect of increased ratio of butyrate to physiological concentrations of acetate and propionate on intestinal integrity and IL-8 secretion in Caco-2 cells" (2018). Graduate Theses and Dissertations. 16463. Iowa State University, Ames, IA.
https://lib.dr.iastate.edu/etd/16463

Shah N, Hendrich S. “Increased ratio of butyrate to acetate and propionate does not does not improve intestinal barrier function against inflammation.” (2017). Poster competition presented and won second place at Norman Borlaug Lecture: World Food Prize Laureate Akinwumi Adesina; 2017 Oct. 16, Ames, IA.

Shah N, Cray N, Pralle D, Thompson K, Faldet R, Whitley E, Jane JL, Hendrich S, Birt DF. “Do resistant starches have long-term protective effects against colorectal cancer?” (2015). Poster session presented at: Diet and Cancer: Animal Studies. Experimental Biology; 2015 Mar. 28 – Apr. 1, Boston, MA.

Shah, N, "Single Residue Determinants in the Binding of Recombinant Human Brain Hexokinase to the Mitochondrion" (2011). Graduate Theses and Dissertations. 12161. Iowa State University, Ames, IA.
https://lib.dr.iastate.edu/etd/12161

Jason Skowronski

PDM Associate

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.

Dana Margittai

Senior Manufacturing Specialist

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. 

Publication

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).

Ashley Shafer

Manufacturing Specialist II

Ashley  supports the product development and manufacture of autologous and allogenic human clinical cell therapies.

Prior to joining Stanford Laboratory for Cell and Gene Medicine, Ashley was a Manufacturing Associate at Miltenyi Biotec located in Sunnyvale, CA. While there, she participated in both the manufacture and process development of T-cells and other cell therapy products within a cGMP environment; formulating final cell product for client clinical operations.

A graduate from Le Moyne College located in Syracuse, NY, Ashley holds a bachelor’s degree in Biological Sciences and a minor in Mathematics. When not hard at work performing procedures in the biomanufacturing of human clinical materials, she enjoys spending time with her family, traveling, and loves trying new food/restaurants to learn about food culture and history.

Vimal Keerthi

Manufacturing Specialist

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.

Haris Khawaja

PDM Associate

Haris Khawaja received his B.S. in General Biology at the University of California – Santa Barbara and joined the Laboratory for Cell and Gene Medicine in May 2020, as a Process Development & Manufacturing Associate. Prior to Stanford, he has 1 year of cGMP cell therapy manufacturing experience.