Summary
Overview
Work History
Education
Skills
Publications
Timeline
Generic

Timur Gaynutdinov

North Potomac

Summary

Principal Scientist with 10+ years of experience in downstream process development for viral vectors and biologics, with deep expertise in lentiviral vector (LVV) purification for cell and gene therapy applications. Proven track record of building scalable, phase-appropriate DSP platforms supporting early discovery through IND-enabling development. Experienced in leading cross-functional programs spanning process development, analytical development, manufacturing, and CMC to deliver robust purification processes, accelerate development timelines, and reduce reliance on external CDMOs. Expertise includes clarification, chromatography, UF/DF (TFF), sterile filtration, DOE/QbD-driven optimization, in-process monitoring, and analytical integration for viral vector manufacturing.

Overview

14
14
years of professional experience

Work History

Principal Scientist II, Protein Science PD

Arcellx
04.2024 - Current
  • Built and implemented two complementary LVV downstream platforms: a high-throughput purification workflow enabling rapid lead selection and a clinical-representative DSP process supporting cell PD and Analytical Development activities
  • Defined and led LVV downstream development strategies across multiple programs, contributing to ~3-month (~20%) acceleration of Discovery-to-CMC timelines and supporting expansion of internal DSP capabilities
  • Designed and optimized downstream unit operations including nuclease treatment, clarification, chromatography, TFF, and sterile filtration to improve recovery, impurity clearance, scalability, and process robustness
  • Evaluated and implemented next-generation downstream purification technologies, including advanced chromatography materials, and membrane-based separation approaches, to improve process efficiency, scalability, and manufacturability
  • Led LVV purification campaigns at up to 50 L scale to generate material for IND-enabling studies and analytical characterization
  • Established at-line and offline analytical workflows to investigate LVV performance losses, enabling root-cause identification, improved process understanding, and enhanced manufacturing reliability
  • Evaluated multi-angle light scattering (MALS) technologies for in-line viral vector PAT applications during chromatography and TFF operations to support real-time process monitoring and improved process understanding
  • Led evaluation and implementation of MRPS particle analysis technologies, including deployment of the Spectradyne nCS2 to support viral vector characterization, process monitoring, and stability/formulation studies
  • Supported development of process monitoring and control strategies through integration of analytical and process performance data
  • Partnered closely with upstream, analytical, manufacturing, and development teams to drive alignment on technical strategy, timelines, and execution
  • Established internal plasmid purification workflows producing high-yield, low-endotoxin GOI and helper plasmids supporting LVV production and process development studies

Principal Scientist, Vector Core

RegenxBio
06.2020 - 11.2023
  • Led cross-functional investigations into GMP manufacturing deviations, identifying root causes and implementing corrective actions
  • Designed and implemented analytical strategies to expand in-process monitoring, improving process understanding and control
  • Developed affinity HPLC-based viral vector titer assays, enabling robust quantitation of process intermediates
  • Established AAV purification workflows using iodixanol density gradient ultracentrifugation for high-purity material generation
  • Trained and mentored scientists on purification and analytical workflows, supporting team capability building

Scientist II, III, Protein group

MacroGenics
11.2014 - 04.2019
  • Developed early downstream process and produced material for a PD-1 × CTLA-4 bispecific antibody, supporting pilot toxicology studies and expediting IND submission
  • Purified and characterized monoclonal antibodies, bispecific/multispecific formats, and recombinant proteins across scales (mg to 50 L), delivering high-quality material for internal and external programs
  • Designed and optimized preparative chromatography workflows (Protein A/G, IEX, HIC, mixed-mode) and filtration strategies for diverse biologics, with focus on yield, purity, and aggregation control
  • Implemented high-throughput purification and characterization platforms (96-well format, SEC-HPLC, CE-SDS) to support cell line development and rapid lead screening
  • Led biophysical characterization of proteins and complexes using MALS, SEC, CE, DSC, DLS, LC-MS, and HPLC to inform developability and candidate selection
  • Maintained and troubleshot chromatography and analytical systems (ÄKTA, HPLC, MALS, DSC, CE-SDS), ensuring reliable operation and data quality

Scientist I, Discovery

Zyngenia Inc.
12.2011 - 07.2014
  • Purified and characterized multi-specific antibodies.
  • Managed protein purification lab operations.

Education

Ph.D. - Bioorganic Chemistry

Novosibirsk Institute of Bioorganic Chemistry, Russian Academy of Sciences
Russia

M.S. - Molecular Biology and Biochemistry

Novosibirsk University
Russia

Skills

  • Viral Vector DSP: LVV purification, phase-appropriate DSP development, process characterization, comparability, control strategy development, technology transfer support, GMP manufacturing support
  • Unit Operations: Clarification, nuclease treatment, chromatography (IEX, affinity, HIC, mixed-mode), UF/DF (TFF), sterile filtration
  • Process Development & QbD: DOE-based optimization, QbD principles, risk assessment, process robustness evaluation, scale-down model support, statistical analysis using JMP
  • Analytical & PAT Integration: In-process monitoring, at-line and offline analytics, PAT workflows, process troubleshooting, ELISA, HPLC, SEC, CE-SDS, DLS, particle analysis platforms
  • Leadership & Collaboration: Cross-functional matrix leadership, technical mentoring, program execution, stakeholder alignment, scientific communication

Publications

  • 1. Scribner JA, Brown JG, Son T, Chiechi M, Li P, Sharma S, Li H, De Costa A, Li Y, Chen Y, Easton A, Yee-Toy NC, Chen FZ, Gorlato S, Barat B, Huang L, Wolff CR, Hooley J, Hotaling TE, Gaynutdinov T, Ciccarone V, Tamura J, Koenig S, Moore PA, Bonvini E, Loo D. Mol Cancer Ther. Preclinical Development of MGC018, a Duocarmycin-based Antibody-drug Conjugate Targeting B7-H3 for Solid Cancer., Sep 23 2020
  • 2. Gaynutdinov T.I., Englund E.A., Appella D.H., Onyschenko M.I., Neumann R.D. and Panyutin I.G. Nucl. Acids Ter. G-quadruplex formation between G-rich PNA and homologous sequences in oligonucleotides and supercoiled plasmid DNA. V. 25(2), 78-84. 2015
  • 3. Onyschenko M.I., Gaynutdinov T.I., Englund E.A., Appella D.H., Neumann R.D. and Panyutin I.G. Nucl. Acids Res. Quadruplex formation is necessary for stable PNA invasion into duplex DNA of BCL2 promoter region. Acids Res., V. 39(16), 7114-7123. 2011
  • 4. Gaynutdinov T.I., Neumann R.D. and Panyutin I.G. Assessing DNA Structures with 125I Radioprobing. In “G-Quadruplex DNA Methods and Protocols”, Series: Methods in Molecular Biology, (Ed. P. Baumann); Springer, V. 608, 137-145, 2010
  • 5. Gaynutdinov T.I., Brown P.H., Neumann R.D. and Panyutin I.G. Duplex Formation at the 5' end Affects Quadruplex Conformation of the Human Telomeric Repeat Overhang in Sodium but not in Potassium. Biochemistry, V. 48, 11169-11177, 2009
  • 6. Onyschenko M.I., Gaynutdinov T.I., Englund E.A., Appella D.H., Neumann R.D. and Panyutin I.G. Stabilization of G-quadruplex in the BCL2 promoter region in double-stranded DNA by invading short PNAs. Nucleic Acids Res., V. 31(22), 7570-7580. 2003
  • 7. Gaynutdinov T.I., Neumann R.D. and Panyutin I.G. Iodine-125 Radioprobing of Intramolecular Quadruplex Conformation of Human Telomeric DNA in the Presence of Cationic Porphyrin TMPyP4. Int. J. of Radiat. Biol., V. 84, 984-990, 2008
  • 8. Gaynutdinov T.I., Neumann R.D. and Panyutin I.G. Structural Polymorphism of Intramolecular Quadruplex of Human Telomeric DNA; Effect of Cations, Quadruplex Binding Drugs and Flanking Sequences. Nucl. Acids Res., V. 36, 4079-4087, 2008
  • 9. Backer M.V., Gaynutdinov T.I., Patel V., Bandyopadhyay A., Thirumamagal B.T., Tjarks W., Barth R.F., Claffey K., Backer J.M. Vascular endothelial growth factor selectively targets boronated dendrimers to tumor vasculature. Mol. Cancer Ther. V. 4(9), 1423-1429, 2005
  • 10. Gaynutdinov T.I., Myshkin E., Backer J.M., Backer M.V. Chimeric ribonuclease as a source of human angiostatin protein for targeted drug delivery. Protein Eng. V. 16, No. 10, 771-775, 2003
  • 11. Backer M.V., Gaynutdinov T.I., Gorshkova I.I., Crouch R.J., Hu T., Aloise R., Arab M., Przekop K., Backer J.M. Humanized docking system for assembly of targeting drug delivery complexes. J. Control Release V. 89, No. 3, 499-511, 2003
  • 12. Backer M.V., Gaynutdinov T.I., Aloise R., Przekop K., Backer J.M. Engineering S-protein fragments of bovine ribonuclease A for targeted drug delivery. Protein Expr. Purif. V. 26, No. 3, 455-461, 2002
  • 13. Gaynutdinov T.I., Shestova O.E., Yakubov L.A., Dobrikov M.I., Vlassov V.V. Sensitized photomodification of oligonucleotide-binding proteins displayed on the eucaryotic cell surface. Russ. Chem. B+ V. 51, No. 7, 1198-1203, 2002
  • 14. Dobrikov M.I, Gainutdinov T.I., Ivanova T.M., Vlassov V.V. Sensitized Site-specific Photomodification of ssDNA by Binary Systems of Oligonucleotide Conjugates: VI. Effect of Substituents in the Sensitizer Anthracene Residue. Russian J. Bioorgan. Chem. V. 26, No. 8, 553-559, 2000
  • 15. Dobrikov M.I., Gaidamakov S.A., Gainutdinov T.I., Vlassov V.V. Sensitized DNA Photomodification of DNA by Binary Systems of Oligonucleotide Conjugates: V. The Target DNA Sequence Effect and the Quantitative Photomodification. Russian J. Bioorgan. Chem. V. 25, No. 2, 118-126, 1999
  • 16. Dobrikov M.I., Bichenkova E.V., Douglas K.T., Gainutdinov T.I., Vlassov V.V. Structure of Photoreactive Binary System of Oligonucleotide Conjugates Assembled on the Target Nucleotide Sequence. J. Biomol. Struct. Dynamics, V. 17, No. 2, 213-221, 1999
  • 17. Dobrikov M. I., Gainutdinov T. I., Vlassov V. V. Visible Light Activatable Binary System of Oligonucleotide Conjugates for Nucleic Acids Modification. Nucleosides Nucleotides V. 18, No. 6-7, 1517-1518, 1999
  • 18. Dobrikov M.I., Gaidamakov S.A., Gainutdinov T.I., Tenetova E.D., Shishkin G.V., Vlassov V.V. Sensitized DNA Photomodification of DNA by Binary Systems of Oligonucleotide Conjugates. IV. Photoinduced Electron Transfer. Russian J. Bioorgan. Chem. V. 25, No. 1, 26-33, 1999
  • 19. Dobrikov M.I., Gaidamakov S.A., Gainutdinov T.I., Tenetova E.D., Shishkin G.V., Vlassov V.V. The Binary System of Oligonucleotide Derivatives of the Perylene and n-Azidotetrafluoro-benzalhydrazone for Sensitized to Visible Light DNA Photomodification. Dokl Acad Nauk, V. 358, No. 3, 403-407, 1998
  • 20. Dobrikov M.I., Gaidamakov S.A., Gainutdinov T.I., Koshkin A.A., Lukyanchuk N.P., Shishkin G.V., Vlassov V.V. Sensitized DNA Photomodification by Binary Systems. I. Synthesis of Oligonucleotide Conjugates and Influence of Their Composition on the Efficiency of Target Modification. Russian J. Bioorgan. Chem. V. 23, No. 3, 171-178, 1997
  • 21. Dobrikov M.I., Gaidamakov S.A., Gainutdinov T.I., Koshkin A.A., Vlassov V.V. Sensitized Photomodification of ssDNA by a Binary System of Oligonucleotide Conjugates. Antisense Nucl. Acid Drug. Develop. V. 7, 309-317, 1997
  • 22. Vlassov V.V., Gaidamakov S.A., Gainutdinov T.I., Koshkin A.A., Dobrikov M.I. Binary Systems of Oligonucleotide Conjugates for Sequence Specific Energy-Transfer Sensitized Photomodification of Nucleic Acids. In “DNA and RNA Cleavers and Chemotherapy of Cancer and Viral Diseases”. (Ed. D. Meunier); Dordrecht: Kluwer Academ. Publ. V. 479, 195-210, 1996

Timeline

Principal Scientist II, Protein Science PD

Arcellx
04.2024 - Current

Principal Scientist, Vector Core

RegenxBio
06.2020 - 11.2023

Scientist II, III, Protein group

MacroGenics
11.2014 - 04.2019

Scientist I, Discovery

Zyngenia Inc.
12.2011 - 07.2014

Ph.D. - Bioorganic Chemistry

Novosibirsk Institute of Bioorganic Chemistry, Russian Academy of Sciences

M.S. - Molecular Biology and Biochemistry

Novosibirsk University
Timur Gaynutdinov