Ph D Flow Cytometry

Chuanwu Wang, Ph. D.

Andover Massachusetts ***** 781-***-**** ad5xy2@r.postjobfree.com https://www.linkedin.com/in/chuanwuwang/

SUMMARY

Experienced bioanalytical scientist of gene/cell therapy products, adeno-associated virus (AAV), infectious diseases, and immunology with a demonstrated history of working in the life sciences research organization & industry.

Strong background in molecular biology & cellular immunology, and immune-oncology study.

Skilled in techniques using animal models, immunological assays, and molecular diagnostic analyses.

Strong scientific research professional and problem-solving skills to support biomedical studies and training.

Good at cell-based assay and PCR assay design, development, and testing on multiple platforms.

Comprehensive experience and knowledge of multi-parameter flow cytometry, data analysis tools as well as LTM (Laboratory Testing Management) System.

Confident in public speaking.

U.S. Citizen.

KEY STRENGTHS

Process and analytical development of gene/cell therapy product.

Molecular Biology, Gene Cloning, Next-Generation Sequencing, RT-PCR, ddPCR, Viral Genome Quantification and infectivity.

Immuno-oncology, Cell-based Assay, Immunoassays, Flow Cytometry (FACS), ELISA, IFA, Microbiome, Biomarker

Immunohistochemistry, Microscopy, Pharmacology, Toxicology, Laboratory and Project Management, Research & Development.

EXPERIENCE

Cellino, Cambridge, MA June 2023 – Present

Associate Director, CMC - Analytical Development/Quality Control

As a leader within the Bioprocess team, provide strategic, technical, and scientific leadership to the AD/QC team.

Create an environment of scientific excellence and innovation, and drive quality principles across the development teams.

Continue to build and manage the team, support analytical testing for partner development teams, manage tech transfer of new methods to the internal QC team, as well as provide expert recommendations to, and oversight of, external test labs.

Review and implement technical improvements to method design, instrumentation, and operational execution.

Provide guidance, create, and implement strategic systems to improve workflows within analytical development including onboarding of digital workflows, automated processes, and other lab practices.

Conduct batch record reviews to ensure compliance with regulatory requirements and internal procedures.

Review manufacturing related deviations and proposed Corrective Actions from CDMO.

Review Out of Specification (OOS) to determine and resolve issues related to product quality.

Collaborate with Contract Development and Manufacturing Organizations (CDMOs) to ensure timely disposition of drug product batches.

Support managing internal quality system processes, including document control, training, change controls, deviations, CAPA, and product complaints.

Act as a Subject Matter Expert (SME) for document control and other quality system processes.

Maintain current knowledge of industry trends and best practices in quality management.

Collaborate closely with other key line functions and communicate complex data/decisions within the department and to program teams and provide effective technical and business leadership at the R&D/CMC interface.

Own the development of process control strategy and partner with the internal Product Development group on the testing strategy of iPSC lines and cell banks.

Evaluate and introduce new analytical technology while assuring harmonization with federal regulations, guidance documents, and overall product testing strategy.

Develop and communicate budgets, project timelines, and risk mitigation strategies to ensure alignment with internal program teams.

Lead a high performing team with a strong individual initiative, deep scientific curiosity, and natural environment of working together collaboratively.

Catamaran Bio, Boston, MA Feb 2023 – May 2023

Associate Director, CMC - Analytical Development

Lead and develop analytical assays for CAR-NK cell drug product release and/or characterization, either internally or at Contract Research and Manufacturing Organizations (CROs, CMOs).

Partner closely with cross-functional experts in Research, Preclinical, Clinical, and Regulatory to ensure highest standards of technical, scientific, and regulatory compliance.

Effectively manage CROs/CMOs to ensure timely completion and delivery of key milestones.

Present results to the team and senior management, as well as author and review batch records, technical reports, and supporting methods.

Author relevant sections of regulatory documents.

Represent Analytical Development on cross-functional program teams.

Mentor junior scientists in the execution of experiments.

Maintain records and documents for IP and regulatory filings.

Editas Medicine, Cambridge, MA April 2021 – Jan 2023

Senior Analytics Manager, CMC - Analytical Development

Act as the subject matter expert on gene/cell therapy product process and analytical development to support potency, impurity, identity testing of drug substance and drug product.

Collaborate with CMO (contract manufacturing organization) and CTL (contract testing lab) to support analytical activities during process development, preclinical, clinical and potentially commercial manufacturing.

Lead Manufacturing Sciences & Technology (MSAT) function to support clinical manufacture of cell therapy products.

Provided analytical support for mRNA and LNP process and analytical development.

Design studies for AAV analytical development, characterization, qualification, validation to support release testing, stability study, and extended characterization.

Lead assay development, qualification, validation, and transfer to internal and external commercial CTL.

Good understanding of biopharma operations, GxPs, ICH guidelines, process characterization/validation and technology transfer.

Provide support for GMP clinical manufacturing activities, including training, troubleshooting, data monitoring, process improvements, and documentation management.

Develop reference standard material qualification strategy.

Lead analytical activity support assay deviations / investigations by designing and executing appropriate studies at CDMOs/CTLs.

Independently design and execute experiments (DOE) to generate optimal and robust analytical assays.

Assess impact and facilitate closure of deviations, ensure appropriate scoping of change controls and CAPAs, and develop risk assessments related to analytical assays.

Author and review technical protocols and reports, CMC regulatory sections, assay summaries, study design and protocols, SOPs.

Prepared information and wrote for clinical study applications (IND/IMPD), market authorization applications (BLA/NDA) and regulatory documents for drug product development milestone regulatory agency meetings, inspections and written responses to CMC related questions.

Establish routine analytical data trending activities and develop release and stability/comparability testing.

In depth understanding and hand on experience in real time PCR (vg titer, residual DNA) or digital droplet PCR (ddPCR), immunoassays (ELISA or MSD for capsid titer and residual protein), residual DNA/protein tests, TCID50 (infectivity titer), NGS, bioburden, endotoxin, virus screen, electron microscopy, analytical ultracentrifugation.

Provided analytical information of IND filings to enable use of cell and gene therapy candidates in the clinic.

Proven project management skills.

Strong communication skills and provide guidance and mentorship to help junior staff with their career growth.

Excellent analytical thinking and problem-solving skills.

Knowledge of statistical methods for DOE design and data analysis (e.g. JMP), experience with Quality by Design (QbD).

Takeda, Cambridge, MA Sep 2020 – April 2021

Senior Scientist, CMC - Analytical Development

Analytical assay development & validation for gene & cell therapy drug substance and drug products and driving the project towards clinical.

Testing methods development for lot/batch release assay of CAR-NK cells.

Oversight for the analytical work performed by CMO and CROs, ensuring adherence to scientific/regulatory requirements, timelines and budgets.

Provided scientific support for technical issues in collaboration with CMO and CRO.

Prepared study reports and approval of protocols and project data that support assay development activities.

Drafted phase appropriate method development, specifications, release assays and certification, stability studies, comparability assessments to enable IND filing.

Cultured immune cells for phenotyping and cytotoxicity assays by flow cytometry.

Charles River Lab, Wilmington, MA Dec 2015-May 2020

Sr Scientist, Microbiome & Molecular Diagnostics

Initiated and developed a microbiome testing platform and service at CRL.

Utilized next-generation sequencing (NGS) to discover novel rodent viruses.

Provided training and hands-on experience of NGS library preparation, nucleic acids quantification (e.g. Bioanalyzer, qPCR), and NGS sequencer.

Isolated immune cell subsets using magnetic bead-based methods or cell sorting by FACS, and cultured immune cells from animals and human whole blood and other primary tissues.

Used PCR, Western blot, multi-parameter flow cytometry, ELISA, MSD and Luminex for biomarker phenotyping and cytokine analysis.

Designed new Charles River’s TaqMan PCR assays and revised existing PCR assays for animal infectious diseases.

Responsible for development, qualification, troubleshooting, and testing of qPCR-based assays, IFA, and Multiplexed Fluorometric Immuno Assay.

Provided scientific support for mammalian cell culture, transfection, viral vector production/purification, and viral vector analytics.

Led R&D activities within the Molecular Diagnostics Department through effectively interacting with multi-disciplinary project teams.

Supervised and mentored junior team members on assay development and testing options.

Implemented emerging technologies in viral vector development and gene therapy.

Developed and optimized pathological tissue collection protocols and assessment schemes in preclinical species.

Prepared SOPs, reviewed test methods and technical datasheets.

Conducted research projects, compiled data and prepared papers for platform presentations/posters at relevant conferences.

Support the commercial testing laboratory with assistance: protocol troubleshooting, optimization, results analysis and interpretation.

Closely work with internal and external customers to understand PCR sampling, test methods, results interpretation, and next steps when a positive infectious agent is found.

Possess a knowledge base regarding infectious agents of concern for multiple lab animal species across CR’s portfolio, including rodents, non-human primates, zebrafish, etc.

Knowledgeable of GxP practices and familiar with ICH, FDA and EMA guidance.

Co-travel with the field sales team to provide customer support services.

Massachusetts Institute of Technology, Cambridge MA March 2012-Dec 2015

Postdoctoral Fellow

Studied cellular and immunological impacts on murine colitis models induced by Helicobacter.

Investigated the effect of interleukin-22 on DNA damage and dysplasia in a murine model of colitis-associated cancer induced by Helicobacter hepaticus.

Isolated and cultured cells from mouse lymph nodes and mucosal tissues.

Utilized multicolor flow cytometry and FlowJo for data analysis.

Examined effects of colonization of gnotobiotic Swiss Webster mice with Helicobacter bilis.

Purdue University, West Lafayette IN June 2005-March 2012

Research Assistant

Studied regulatory T cells (Tregs) and Th17 cells in mucosal immunology.

Processed, cultured, and maintained cell lines and primary immune cells.

Generated FoxP3+ and IL17+ T cells in vitro from isolated naïve T cells of mice and humans.

Investigated tumor-infiltrating T cells migration and function in vivo and in vitro.

Extensively used multi-color flow cytometry, microscopy, ELISA for my immunology research projects.

Examined B cell phenotypes by ELISPOT.

Used inflammatory bowel disease/colitis disease and experimental autoimmune encephalomyelitis animal models.

Investigated colon cancer, breast cancer, and melanoma enriched T cell biology.

Examined human tonsil PD1+ germinal center T cell subsets and functions.

EDUCATION

Purdue University, West Lafayette IN

Ph.D. of Immunology, June 2005-December 2011

China Agricultural University, Beijing China

Master of Veterinary Pathology, September 2001-July 2004

China Agricultural University, Beijing China

Bachelor/D.V.M., September 1997-July 2001

HONORS AND AWARDS

Murine Chapparvovirus (MuCPV) Assay Development Award, Charles River Laboratories 2019

Bilsland Dissertation Fellowship, Purdue University, 2010-2011

AAI Trainee Abstract Awards, AAI, Seattle, 2009

National Phi Zeta Manuscript Award Nominees, Purdue University, Basic Science, 2009

Ross Fellowship, Purdue University, 2005-2006

PROFESSIONAL MEMBERSHIP

2020-current: Member, Association of Primate Veterinarians

2018-current: Member, American College of Laboratory Animal Medicine

2012-current: Member, American Association of Laboratory Animal Science

2012-2015: Student Member, Society of Toxicological Pathology

2009-2015: Student Member, American Association of Immunologists

REVIEWING ACTIVITIES FOR SCIENTIFIC JOURNALS

Cellular & Molecular Immunology

Journal of Immunology

Journal of Interferon & Cytokine Research

PLOS One

Cancer Research

Journal of Clinical Immunology

International Immunology

Clinical & Experimental Immunology

Immunology

PUBLICATIONS

(Total refereed publications: 23; Total Citations = 965 (as of 1/11/2023 by Google Scholar);h-index* = 8; i10-index** = 8. Note: *h-index = h publications with at least h citations; **I10-Index = Number of publications with at least 10 citations)

Mark T Whary, Chuanwu Wang, Catherine F Ruff, Mallory J DiVincenzo, Caralyn Labriola, Lillian Ge, Yan Feng, Zhongming Ge, Vasu Bakthavatchalu, Suresh Muthupalani, Bruce H Horwitz, James G Fox. Effects of Colonization of Gnotobiotic Swiss Webster Mice with Helicobacter bilis. Comp Med. 2020 Apr 29. doi: 10.30802/AALAS-CM-19-000087

Zhongming Ge, Alexander Sheh, Yan Feng, Sureshkumar Muthupalani, Lili Ge, Chuanwu Wang, Susanna Kurnick, Anthony Mannion, Mark T Whary, James G Fox. Helicobacter pylori-infected C57BL/6 mice with different gastrointestinal microbiota have contrasting gastric pathology, microbial, and host immune responses. Scientific reports, 2018, 8 (1), 1-15. (Cited by 10)

C Wang, G Gong, A Sheh, S Muthupalani, EM Bryant, DA Puglisi, H Holcombe, EA Conaway, NAP Parry, V Bakthavatchalu, SP Short, CS Williams, GN Wogan, SR Tannenbaum, JG Fox, BH Horwitz. Interleukin-22 drives nitric oxide-dependent DNA damage and dysplasia in a murine model of colitis-associated cancer. Mucosal immunology, 2017, 10 (6), 1504-1517. (Cited by 26)

Chuanwu Wang, Michelle Wunderlich, Kenneth Henderson. Murine roseolovirus, historically known as murine thymic lymphotropic virus. Journal of virology, 2017, 91 (18), e00943-17. (Cited by 1)

Naresh S Redhu, Vasudevan Bakthavatchalu, Evan A Conaway, Dror S Shouval, Amy Tsou, Jeremy A Goettel, Amlan Biswas, Chuanwu Wang, Michael Field, Werner Muller, Andre Bleich, Ning Li, Georg K Gerber, Lynn Bry, James G Fox, Scott B Snapper, Bruce H Horwitz. Macrophage dysfunction initiates colitis during weaning of infant mice lacking the interleukin-10 receptor. Elife 2017 (6), e27652. (Cited by 9)

Mark T Whary, Chuanwu Wang, Lili Ge, Yan Feng, Zhongming Ge, Vasudevan Bakthavatchalu, Sureshkumar Muthupalani, Bruce Horwitz, James G Fox. Activation of Gut-Associated Tertiary Lymphoid Tissue in Gnotobiotic Swiss Webster Mice Distinguishes Helicobacter Bills, a 'Provocateur Pathosymbiont', from Segmented Filamentous Bacteria. Gastroenterology, 2017, 152 (5), S1000.

Guanyu Gong, Chuanwu Wang, Sureshkumar Muthupalani, Nicola M Parry, Vasudevan Bakthavatchalu, Gerald Wogan, Steven R Tannenbaum, James G Fox, Bruce Horwitz. IL-22-Dependent iNOS Induction Drives DNA Damage in a Murine Model of Colitis-Associated Cancer. Gastroenterology, 2016, 150 (4), S125

Naresh Redhu, Dror Shouval, Vasudevan Bakthavatchalu, Chuanwu Wang, Evan Conaway, Jeremy Goettel, Matthias Mack, Andre Bleich, Lynn Bry, James Fox, Scott Snapper, Bruce Horwitz. Microbiota drives inflammation by altering intestinal lamina propria macrophage phenotype in a novel IL10R-deficient model of very early onset IBD. Inflammatory Bowel Diseases 2016, 22 (suppl_1), S51-S51. (Cited by 6)

Z Ge, Y Feng, A Sheh, S Muthupalani, C Wang, L Ge, JG Fox. Influence of Gastrointestinal Microbiota on Pathogenic Potential of Helicobacter pylori in C57BL/6 Mice. Gastroenterology 2015, 148 (4), S-688.

Z Ge, Y Feng, A Sheh, S Muthupalani, C Wang, L Ge, JG Fox. Influence of Gastrointestinal Microbiota on Pathogenic Potential of Helicobacter pylori in C57BL/6 Mice. Helicobacter 2014(19), 87-87.

Wang C, Shankar Thangamani, Myunghoo Kim, Bon-Hee Gu, Lee JH, Taparowsky EJ, Kim CH. BATF is required for normal expression of gut homing receptors by T helper cells in response to retinoic acid. J Exp Med. 2013 March 11; 210 (3): 475-489. (Cited by 44)

Wang C, Lee JH, Kim CH (2012) Optimal Population of FoxP3+ T Cells in Tumors Requires an Antigen Priming-Dependent Trafficking Receptor Switch. PLoS ONE 7(1): e30793. (Cited by 33)

Wang C, Hillsamer P and Kim CH. Phenotype, effector function and tissue localization of PD-1-expressing human follicular helper T cell subsets. BMC Immunology 2011 September 13; 12:53. (Cited by 56)

Betz BC, Jordan-Williams KL, Wang C, Kang SG, Liao J, Logan MR, Kim CH, Taparowsky EJ. Batf coordinates multiple aspects of B and T cell function required for normal antibody responses. J Exp Med. 2010 May 10; 207 (5): 933-42. (Cited by 169)

Wang C, Kang SG, Hogenesch H, Love PE, Kim CH. Retinoic Acid Determines the Precise Tissue Tropism of Inflammatory Th17 Cells in the Intestine. J Immunol. 2010, 184, 5519 -5526. (Cited by 109)

Kang SG, Wang C, Matsumoto S, Kim CH. High and low vitamin A therapies induce distinct FoxP3+ T cell subsets and effectively control intestinal inflammation. Gastroenterology. 2009 Oct; 137 (4):1391-402. (Cited by 85)

Lee JH, Wang C, Kim CH. FoxP3+ regulatory T cells restrain splenic extramedullary myelopoiesis via suppression of hemopoietic cytokine-producing T cells. J Immunol. 2009 Nov 15; 183 (10):6377-86. (Cited by 29)

Wang C*, Kang SG*, Lee J, Sun Z, Kim CH. The roles of CCR6 in migration of Th17 cells and regulation of effector T-cell balance in the gut. Mucosal Immunol. 2009 Mar; 2 (2):173-83. (*Co-first authors, cited by 211)

Qin X.H., Zhang B., Li J., Wang C.W., Yang J.M., Liu J., Zhao D.M. The Sterilization Effect of Glutaraldehyde Compound Disinfectant on Some Swine Viruses. Acta Lab Anim Sci Sin. 2002, 10 (2): 116-119

Zhang B., Qin X.H., Li J., Wang C.W., Zhao D.M. Test on Efficacy of Complex Disinfectant of Glutaraldehyde and Quaternary Ammonium Salt. Progress in Veterinary Medicine. 2002, 23 (3): 70-71

Zhang B., Qin X.H., Li J., Yang J.M., Wang C.W., Zhao D.M. Study on Efficacy of the Mixed Disinfectant of Glutaraldehyde and Quaternary Ammonium Salt against Chicken Pathogen Microorganism. Chin J Lab Anim Sci. 2002,12 (2): 95-98

Wang C.W., Zhao D.M. The Production of Polyclonal Antibody in Laboratory Animals I. Refinement of Immunization Protocol. Laboratory Animal Science and Administration. 2002,19 (4) : 40-43

Wang C.W., Zhao D.M. The Production of Polyclonal Antibody in Laboratory Animals .Overiew of Adjuvants. Laboratory Animal Science and Administration. 2003,20(1) : 43-45

Yu S.M., Wang C.W., Zhao D.M., Zhang Q.C., Pei D.Z. Raising and Pathogen Purification of Chinese Experimental Mini-Pig. Laboratory Animal Science and Administration. 2003,20 (2) : 44-46

Wang C.W., Xu B.R., Zhao D.M., Gao H.D., Li G. Diagnosis and Prevention of Silkychiken Marek’s Disease. China Animal Husbandry & Veterinary Medicine. 2003,30 (3) : 46-47

Wang C.W., Yang J.B., Zhao D.M., Qin X.H. Effects of FK309 Combined with BCG on Sarcoma 180 Cells induced Tumor. Chinese Journal of Comparative Medicine. 2003, 13(4) :193-196

Yu S.M., Zhao D.M., Li J., Qin X.H., Ning Zh.Y., Yang J.M., Huang L., Wang C.W., Hao J.F. Histopathological Observation of Bovine Brain Tissue. Chinese Journal of Veterinary Science. 2004, 37 (3): 45-49

Hao J.F., Wu B., Zhao D.M., Ning Zh.Y., Wang C.W., Yu S.M., Su Sh.N. The Study on Pathological Effects of Brain after High +Gx overload from Spaceship Emergency Return in Rhesus. Space Medicine Medical Engineering. 2004, 17 (3): 171-175

He C., Zhu H., Wang C.W. Investigation on Immune Response Elicited in Boiler Immunized with Recombinant Major Outer-Membrance Protein of Chlamydia Psittaci. Journal of China Agricultural University. 2004, 9 (1): 45-48

Wang C.W., He C., WANG L.L., Zhao D.M. Diagnosis of Egg Breeding Chicken Aspergillosis. Chinese Journal of Veterinary Medicine. 2004, 40 (4): 16-18

Zhou Q.P., Wang C.W. The Discussion of Cured Methods for Canine Organic Phosphor Toxicosis. Chinese Journal of Veterinary Medicine. 2004, 40 (7): 32-33

Yang C.J., Hao J.F. Wang C.W., Wang J.X., Xu X.F., Zhao D.M. The Pathological Effect of the Chinese Medicine-Shenqing to Organs of Rat. China Animal Husbandry & Veterinary Medicine. 2004, 31(11) : 39-42

Qin X.H., Kang A.J., Zhao D.M., Yang J.M., Ning Z.Y., Huang L., Wang C.W., Yu S.M., Ma L.Y. Effect of Biological Dressing on Deep Second Degree Burning Wound Healing of Rat. Chinese Journal of Veterinary Science. 2004, 24(3): 283-284, 288

BOOK

As one of the contributors for the book- Avian Disease Diagnosis and Prevention (the First edition, China Agricultural University Press, 2003)

ORAL PRESENTATIONS

1.“Novel Virus Discovery by Next Generation Sequencing”, The AALAS 2019 National Meeting in Danvers, Colorado, October 2019.

2.“Development and Qualification of a Probe-Based Fluorogenic RT-qPCR for the Detection of Zika Virus In Nonhuman Primates”, The AALAS 2016 National Meeting in Charlotte, North Carolina, October 2016.

3.“IL-22 Regulates the Early Innate Immune Response to Helicobacter hepaticus Infection”, The AALAS 2015 National Meeting in Phoenix, Arizona, November 2015.

4.“Retinoic Acid Determines the Precise Tissue Tropism of Inflammatory Th17 Cells in the Intestine”, The 39th Autumn Immunology Conference, Chicago, Illinois. November 20, 2010.

5.“The role of CCR6 in migration of Th17 cells to the intestine”, The 96th Annual Meeting of The American Association of Immunologists, Seattle, May 9, 2009.

POSTERS

1.“Murine Astrovirus 2: A Novel Virus Infecting Laboratory Mice”, The AALAS 2018 National Meeting in Baltimore, Maryland, October 2018.

2.“Characterizing the Infectivity, Tissue Tropism, and Pathology of MuAstV2, a Novel Murine Astrovirus”, The AALAS 2018 National Meeting in Baltimore, Maryland, October 2018.

3.“Next Generation Sequencing of a Novel Astrovirus Detected in a Research Colony Of Mice”, The AALAS 2018 National Meeting in Baltimore, Maryland, October 2018.

4.“Temporal Microbiome Evaluation in Wistar Han Rats after Shipping from a Vendor to a Preclinical Testing Facility”, The AALAS 2018 National Meeting in Baltimore, Maryland, October 2018.

5.“Gut Microbiome Diversity in C57BL/6 Mice Is Associated with Age and Gender within the Same Barrier Facility”, The AALAS 2017 National Meeting in Austin, Texas, October 2017.

6.“Development of an Internal Control to Evaluate the Accuracy of 16S rRNA Next Generation Sequencing”, The AALAS 2017 National Meeting in Austin, Texas, October 2017.

7.“Determining the Mouse T Lymphotropic Virus Genome by Next Generation Sequencing”, The AALAS 2017 National Meeting in Austin, Texas, October 2017.

8.“IL-22 Promotes Helicobacter Hepaticus-Induced H2AX Phosphorylation and Dysbiosis in the Large Bowel”, the 2015 IBD Conferences of Crohn's & Colitis Foundation in Orlando, Florida, December 2015

9.“Antimicrobial Peptides Are Induced in the Lower Bowel after Helicobacter hepaticus Infection”, The AALAS 2014 National Meeting in San Antonio, Texas, October 2014.

10.“Antimicrobial peptides are induced in the lower bowel after acute Helicobacter hepaticas infection”, The 101st Annual Meeting of The American Association of Immunologists, Pittsburgh, Pennsylvania, May 2014.

11.“Helicobacter bilis Induces Gastrointestinal Lymphoid Hyperplasia of B220+ B Cells in Gnotobiotic Swiss Webster Mice”, The AALAS 2013 National Meeting in Baltimore, Maryland, October 2013.

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