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.

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

 

Cancer Cell Therapy (CCT) Team

Ramya Tunuguntla, PhD

Director

Bio coming soon!

Sunny Patel

Manufacturing Specialist II

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.

Carley Fowler

Research and Development Specialist

Carley graduated from Santa Clara University with a M.S. in Bioengineering. At SCU, she engineered exosomes to express surface proteins that target specific disease pathways with the goal to disrupt the disease progression. Joining the team at LCGM, Carley hopes to contribute to the process development research of CAR T-cell therapies.

Dorota Klysz

Senior Process Development Scientist

Dorota is the Senior Process Development Scientist for the Mackall Lab at the Center for Cancer Cell Therapy and Laboratory of Cell and Gene Medicine (LCGM), Stanford University. 

Vimal Keerthi

PDM Scientist

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.

Janette Mata

Manufacturing Specialist

Janette joins the Center of Cancer Cell Therapy team as a Process Development and Manufacturing Specialist II. Janette graduated from Santa Clara University with a B.S in Biology and minor in Public Health, where she was able to gain experience working with mammalian cell cultures. 

Since joining the team, Janette manufactures CAR-T cells for ongoing clinical trials at the Stanford Cancer Institute and contributes to the process development research of CAR T- cell therapies when possible.

Annie Brown

Manufacturing Lead

Annie is a manufacturing lead 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.

Brian Hoang

Manufacturing Specialist II

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.              

Stephen Moran

Manufacturing Specialist II

Stephen joins the Center of Cancer Cell Therapy team as a Process Development and Manufacturing Specialist II with a B.A. in Biological Sciences from San Jose State University. He has also gained several associate degrees and gained GMP experience in while working at Boehringer Ingelheim in Fremont CA.  While at Boehringer Ingelheim, he gained experience in purification by manufacturing various buffer preparations, execution of bind and elute and flow through chromatography, utilization of various filtration systems, and ultimately freezing of final product of products ranging from 2K and 12K. At LCGM, Stephen is responsible for manufacturing and production of Phase I/II CAR-T cells for clinical trials. Joining the team in April 2022, Stephen is excited to learn CAR-T therapies as well as helping his LCGM team.

Kyle Asano

Manufacturing Specialist II

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.

Anne-Louise Gramstrup Petersen

CMC Operations Manager

Bio coming soon!

Center for Definitive & Curative Medicine (CDCM) Team

Prachi Wani

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.

 

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.

Alexander Anneling

Clinical Manufacturing Manager

Alexander joins us from the New York Stem Cell Foundation where he worked as a scientist and project manager, developing the platform for the production of clinical grade iPSC. Additional background includes tech transfer, client success management, process development to cGMP manufacture, and project implementation. He graduated from the University at Buffalo with a B.S. in Chemical and Biological Engineering and holds the PMP certification from the Project Management Institute. He joined Stanford LCGM as the clinical manufacturing manager in February 2022.

Catherine Terry

PDM Associate

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.

Tim Van Horn

Manufacturing Associate

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.

Anju Joseph

Manufacturing Specialist

Anju joined Stanford Laboratory for Cell and Gene Medicine (LCGM) as a Process Development and Manufacturing Specialist II. She graduated from Cochin University of Science and Technology (CUSAT), India, with master's in Biotechnology. She holds a PG diploma in bioprocessing and certification in biosciences from Keck Graduate Institute, Claremont. Anju has previously worked in Biocon Ltd, India, where she dealt with the upstream process of both biosimilars and novel biologics and gained GMP experience.

Having worked in the biopharmaceutical sector for two years, Anju is very enthusiastic to learn new techniques associated with the clinical manufacturing of gene and cell therapy products and to contribute her best to the team.

Kanksha Patel

Manufacturing Specialist

Kanksha earned her B.S. in Bioengineering: Biotechnology from UC San Diego in June 2022. At UCSD, she performed microbiology and tissue engineering research to study methods for ACL reconstruction. Her background also includes cleanroom experience where she used photolithography to manufacture wafers for industrial use. Kanksha is proud to be a part of the CDCM team at LCGM and help develop products for innovative patient therapies.

Kanksha Patel

Manufacturing Specialist

Kanksha earned her B.S. in Bioengineering: Biotechnology from UC San Diego in June 2022. At UCSD, she performed microbiology and tissue engineering research to study methods for ACL reconstruction. Her background also includes cleanroom experience where she used photolithography to manufacture wafers for industrial use. Kanksha is proud to be a part of the CDCM team at LCGM and help develop products for innovative patient therapies.

Keri Marie Tate, PhD

Associate Director

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).

Dana Margittai

PDM Scientist

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).

Girija Vasudevan

Manufacturing Specialist II

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.

Claudia Flautero

Manufacturing Specialist II

Claudia earned her B.S. in Microbiology from the Javeriana University in Colombia. After working in quality control, she moved to San Francisco to study Biotechnology. She went to CCSF to improve her lab skills where she took Biotechnology and Stem Cell Culture classes, while working at BioMarin and BABEC. Later, she earned her PSM in Biotechnology from University of San Francisco and worked at PACT Pharma after. From there she joined the CDCM team, in September of 2021. She is excited to be part of the team and very proud of the work performed at the LCGM and to be part of the Stanford community. 

James Dinh

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.

Gabriella Zucchiatti

Manufacturing Assistant

Gabriella received her B.S in Biomedical Science from Oklahoma City University in May of 2020. During her time in Oklahoma, she would volunteer for the Blue Thumb Water Project where she would help collect and analyze stream water samples weekly, and gather and identify the macroinvertebrates inhabiting the streams.  She was also a part of the Women’s Softball team, and placed 2nd in the country in the 2019 Women’s NAIA Softball Championships. After college, Gabriella worked in a dialysis testing lab in the Environmental department where she would determine the sterility of dialysis machines, as well as ion concentration of water samples.  This is Gabriella’s first GMP lab that she will be working at, and is very excited to be part of the LCGM PDM team!