Tom Chen

About Tom Chen

As the Senior Director and Head of Drug Substance and Early Development CMC Lead at Dianthus Therapeutics, I oversee the CMC team for biologic products in pre-clinical and clinical stages. I direct and develop the clone selection, cell culture, process development, product characterization, analytical method development/validation, and regulatory document preparation. I also build and maintain strong relationships with internal and external partners to ensure successful analytical strategies for the pipeline molecules.I have over 20 years of experience in protein biochemistry research and drug development, with a PhD in Biochemistry from Max Planck Institute and LMU Munich. I have extensive expertise in LC-MSMS, peptide mapping, quantitative proteomics, HCP analysis, and intact mass analysis for biologics, antibodies, ADCs, small molecules, oligonucleotides, and COVID-19 test kits. I have supported the BLA submission of several anti-hemophilia biologics and contributed to the discovery and development of various drugs for cancer and immuno-oncology. I am passionate about driving innovation and excellence in the biopharma industry and advancing the health and well-being of patients.

Experience

1. Senior Director, Head of Drug Substance and Msat

   Dianthus Therapeutics, Inc.

   Dec 2024 — Present · Boston, MA, US

   Lead and manage the Drug Substance team to support discovery, candidate evaluation, and early CMC development of biologics, including monoclonal antibodies, bispecifics, and fusion proteins.• Design phase-appropriate CMC strategies and detailed work plans, and drive execution through internal resources and strategic partnerships with CDMOs.• Evaluate CDMO proposals and develop statements of work (SOWs) for clinical drug substance manufacturing; conduct onsite audits and provide final recommendations.• Lead formulation development, including high-concentration liquid formulations (150–200 mg/mL) for early- and late-stage programs, supporting the development of APFS and autoinjector presentations.• Direct all CMC Drug Substance activities, including clone selection, MCB/WCB generation, upstream cell-culture development, downstream purification development, product characterization, GMP manufacturing, and preparation of IND/BLA documentation.• Oversee stability programs, comparability studies, and the establishment of phase-appropriate specifications and control strategies.• Lead late-stage scale-up from 500 L to L, including process characterization (PC), process validation (PV), and PPQ activities in support of BLA and commercial manufacturing.• Support drug product and device development, including PFS filling, APFS, and autoinjector development.• Lead the tech transfer team to ensure smooth and efficient knowledge transfer and process transfer between sending and receiving CMOs.

Education

• Ludwig-Maximilians-Universität München

  PhD, Biochemistry

• Max Planck Society

  Ph,D, Biochemistry

Skills

• Laboratory
• Confocal Microscopy
• Elisa
• Lc/Msms
• Genetics
• Proteomics
• Western Blotting
• Biotechnology
• Protein Purification
• Qpcr
• Dls
• Characterization
• Chromatography
• Public Speaking
• Cell Biology
• Consulting
• Cell Culture
• Bioinformatics
• Microbiology
• Microscopy
• Pharmaceutical Industry
• Sop
• Analytical Chemistry
• Cell
• Life Sciences
• Molecular Cloning
• Mass Spectrometry
• Science
• Biochemistry
• Cief
• Dna
• Protein Chemistry
• De Novo Sequence
• Hplc
• Biophysics
• Antibodies
• Purification
• Protein Expression
• Glp
• Drug Discovery