Chongfeng Xu

Principal Scientist @ Biogen

About

Accomplished in analytical CMC of biologics (protein and gene therapy), including analytical control strategy, method development, detailed characterization, process/product development support, comparability, stability and SAR studies, and regulatory filling support of protein (mAb and recombinants) and GT (AAV) modalities. Proven technology innovation leader who has developed cutting-edge methods for the characterization of aggregate, degradants, sequence variant, and host cell protein using advanced separation methods and mass spectrometry.

Country

United States

City

Boston

Industry

Research

Skill

Mass Spectrometry, LC-MS, Proteomics, Purification, Protein Chemistry, Cell, Characterization, Biochemistry, Biopharmaceuticals, Cell Biology, HPLC, Liquid Chromatography-Mass Spectrometry (LC-MS), Molecular Biology

Experience

Principal Scientist

Biogen

2021-10 - Present · 4 yrs 11 mos

- Analytical rep for multiple protein and gene therapy (AAV) programs including a biosimilar. Led AD's filling support of Aducanumab (Aduhelm), the first FDA-approved disease-modifying therapy for Alzheimer's disease in multiple markets. - Guided chemistry assay development of AAV based gene therapy drugs. - In-depth study of the impact of cell culture conditions to product titer and quality through PQ, amino acid feed, metabolite and trace metal analysis at GMP manufacturing scale.

Senior Scientist

Biogen

2018-4 - 2021-10 · 3 yrs 7 mos

Cambridge, MA

- Analytical Development (AD) program reps of protein and gene therapy therapeutics for neurology, immunology and blood diseases. Represented AD in cross-functional core team to develop next generation end-to-end platform process for therapeutical antibodies. - Developed innovative strategies/workflows for the characterization of sequence variant and HMW species.

Scientist II

Biogen

2014-1 - 2018-3 · 4 yrs 3 mos

Cambridge, MA

- Method development and program representation of mAb drugs for neurodegenerative diseases including Alzheimer’s disease and Parkinson disease. - Developed advanced LC-MS methods/workflows for host cell protein, aggregates and degradants of mAbs.

Scientist I

Biogen

2009-8 - 2014-1 · 4 yrs 6 mos

- Method development and characterization of protein therapeutics (mAb, Fc-fusion and bispecific). Supported detailed characterization and analytical comparability of biosimilars (of Herceptin and Humira). - Guided/provided analytical supports for process/product development, process characterization/validation, comparability, forced degradation, structure-activity relationship (SAR), and formulation stability study.