Yuqian Ma, Ph.D.


Experienced in translational medicine, GMP manufacturing for viral vectors and various cel; and gene-modified products, and CGT regulatory filings

About Yuqian

Yuqian’s passion in bringing cutting-edge science to patients started when she studied as a Ph.D. student. Since then, she has worked both in academic institutions and in industry focusing on bringing cell and gene therapy products to patients. Yuqian brought to Dark Horse her expertise in viral vector and cell therapy products GMP manufacturing; in-depth knowledge in process improvements/optimization and comparability justifications throughout CMC development from clinical to commercial stage for CGT products; and operational and resource planning, as well as timeline and risk management in cell and gene therapy product development.

During Yuqian’s time at DHC, she has focused a great deal on regulatory writing projects across the spectrum from pre-IND to BLA, across five regulatory regions. She has provided support across various modalities and technologies, such as viral vectors, CRISPR, mRNA, and gene modified cell products. She also enjoys providing technical opinions and judgement (especially relative to client audits) and CMC support such as CDMO selection.

During her previous tenures, Yuqian had extensive experience in GMP/GCP inspection activities, supply audits, engaging with Regulatory Agencies in areas such as GMP licensure, GMP facility design, and engaging with EMA and FDA for IMPD/IND fillings, as well as for MAA/BLA filings.

Earlier in her career, Yuqian spent 7 years in a GMP manufacturing facility in King’s College London, pioneering the manufacturing of a clinical grade lentiviral/retroviral vector to supply multiple clinical trials in EU and US. She left King’s as the Head of the Production, where she recruited and trained a GMP manufacturing team with the capacity of manufacturing 20 batches of 10L viral vectors per year and managed two MHRA licensed GMP facilities, as well as a new facility being built for future expansion.

Just before joining DHC, Yuqian worked at Orchard therapeutics as the CMC lead for a late-stage stem cell gene therapy product for a rare disease; while at Orchard, she was one of the authors in MAA filing for a product treating a devastating condition called Metachromatic Leukodystrophy (MLD), which had been granted approval in 2020 by EMA (Libmeldy™).


  • CMC lead for the commercialization of a stem cell product; exclusively responsible for the filing strategy, gap analysis, briefing book preparation for engaging with FDA and EMA to explore regulatory pathways
  • Lead author for MAA drafting and submission of an autologous genetic modified stem cell product for rare disease: Libmeldy ™
  • Head of a GMP production team supply clinical grade viral vectors for various clinical trials; including the vector used in the successful treatment of the world’s very first patient with allogeneic CAR-T therapy for leukemia (https://www.gosh.nhs.uk/press-releases/world-first-use-gene-edited-immune-cells-treat-incurable-leukaemia/)
  • Obtained MHRA GMP license for a newly-built GMP facility; heavily involved in inspection activities from both MHRA and HTA


Orchard Therapeutics
Associate Director, CMC lead
Senior Manager, Cell Therapy Operation

Cell and Gene Therapy, King’s College London
GMP Production Manager
GMP Production Scientist/Senior Production Scientist
Postdoc Research Associate


King’s College London, UK
PhD in Medicine

King’s College London, UK
Master of Science

Jiangsu University, China
Bachelor of Medicine

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