Partnership Expands Biologics Capabilities

Our partnership with Jade Biomedical will further strengthen CMC support in Asia. As a premiere Contract Quality Organization (CQO) strategically based in Shanghai and Suzhou, China, Jade offers end-to-end GMP testing services built upon an in-depth understanding of quality systems that comply with Chinese health authorities and global regulatory standards. In addition to analytical testing, Jade offers support for regulatory submissions, quality assurance, cold chain management, and facility design. Innovative companies in pursuit of cell, gene, and other biologic therapies can harness local CMC expertise, quality systems, and a global scientific network to support their development without having to invest in these in-house resources.

Leadership Team

  • Dr. Claudia Lin, Founder & CEO

    Claudia Lin Headshot

    Dr. Lin has had a successful career working in research and development, product development, and commercial product operations across the world. She worked as a scientist in California working with anticancer drugs at Berlex Biosciences and Exelixis Inc. before switching to a more operational role as an associate director working to ensure QC in clinical development and product quality for Geron and Genentech – both based in California.

    After stints at Bayer and Innovent Biologics, she founded Jade Biomedical, working with a passion to advance biopharmaceutical development in China and beyond.

    Dr. Lin has a PhD in cell and molecular biology from the University of California, Berkeley, and has conducted post-doctoral work at the Howard Hughes Medical Institute (CA) studying differentiation in the nervous system and Lawrence Berkeley National Laboratory studying malignant mechanisms of breast cancer.

  • David Kapitula, Chief Operating Officer

    David Kapitula Headshot

    David Kapitula has had a successful career working in QA and QC across several companies across the US and Asia Pacific. His previous employers include Imclone Systems, Bayer, and Roche/Genentech among others, working in various roles relating to Quality Control and Quality Assurance. His current responsibilities at Jade Biomedical including looking after the technical and financial operations along with business development.

    David has a master’s degree from the Albert Einstein College of Medicine in New York studying the molecular biology of the spinal cord and a MBA studying engineering and business management at the University of Pennsylvania.

Available Services

Jade Biomedical facilitates the rapid growth, evolution, and valuation of early and late-stage companies/products from research into clinical product development, providing phase appropriate and scalable global quality systems with a cost and time-effective solution.

Types of Samples

Environment Testing

Raw Material Testing

Cell Bank

DSP Process Control

In-Process and Final Product

  • Cleanroom validation
  • Environmental monitoring
  • Cleaning validation
  • Disinfectant validation
  • Pure water/water for injection
  • Potency assay
  • Contaminant assay
  • RCB
  • MCB
  • WCB
  • EOPC
  • IND viral clearance
  • BLA viral clearance
  • UPB
  • DS
  • DP

 

Biologics Testing Services

Characterization

Molecular

Microbiology/EM

Safety Testing

General

  • Deamidation
  • CDC
  • ADCC
  • PBRT
  • Co-Culture Virus
  • qPCR Virus (Specific)
  • RCR
  • RCA
  • RCL
  • Identity (Cell)
  • Construct Copy No.
  • Sequence
  • Determination of Virus Particle Count
  • Virus Titer Determination
  • Restriction map
  • Cell Line Stability
  • MW
  • AAA
  • N-Term AA
  • C-Term AA
  • Free Sulfhydryl
  • Glycan Profile
  • Oligosaccharide Comp. / Dist.
  • SEC
  • IEC
  • CE SDS (Reduced)
  • CE SDS (Non-Reduced)
  • Residual ProA
  • Host Cell DNA
  • HCP
  • Peptide Mapping
  • cIEF
  • Glycan Profile
  • Cell Based (Potency)
  • ELISA (Potency)
  • FACS
  • ICP
  • B.I. - Sterility
  • Bacteriostasis / Fungistasis
  • Bioburden
  • Endotoxin (Gel Clot)
  • Endotoxin (Kinetic)
  • Growth Promotion Media / Reagents
  • Identification
  • Media Hold - Sterility
  • Sterility
  • Clean Utilities Testing (Water, Gas, Steam)
  • Environmental Monitoring
  • Spirochete (mAb)
  • Mycoplasma Culture (EP/USP/JP)
  • Mycoplasma Culture (CHP)
  • Mycoplasma qPCR
  • TEM
  • SEM
  • Gram Stain
  • Adventitious Agents / Virology Testing (AVA / VT)
  • Appearance
  • Color and Clarity
  • pH
  • Osmolality
  • Sub Visible Particulate
  • Volume in Container
  • UV (Conc.)
  • Cell Count Viability

 

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Locations & Contact Information

Suzhou, China (Headquarters)
Unit 202, Tower B at No. 388 Xinping St.
Suzhou Industrial Park
Suzhou, Jiangsu, China, 215123

Shanghai, China
Building 5, Room 305A, 131 Kaiqing Road,
Pudong District, Shanghai, China 200135

Contact
+86-0512-62750096
[email protected]