Research & Development Services

 

Model: Analytical services

Category: *CRO

Exhibitor: GCCL CO., LTD.

Booth No: L721

 

Characteristic

 

GCCL’s R&D Laboratory leads the development of innovative analytical methods to support clinical sample analysis for next-generation biologics, biosimilars, and precision medicine.

1. Purpose-Driven Innovation
- Established in 2024 to enhance technical capabilities in bioanalysis
- Focused on method development, validation, and platform optimization
- Accelerates clinical timelines by introducing cutting-edge technologies early

2. Advanced Development Projects
- Development of PK and immunogenicity assays for biosimilars (e.g., Keytruda, Yervoy, Perjeta, Eylea)
- In-house multiplex ELISpot and MSD-based biomarker panels
- High-sensitivity assays for CNS biomarkers (e.g., α-synuclein, GFAP, Neurogranin)

3. Expertise in Complex Modalities
- Specialized in cell & gene therapy, CNS diseases, infectious diseases, and oncology
- Development of neutralization assays using in-house virus cultures (e.g., RSV, SARS-CoV-2)
- ddPCR-based DNA shedding analysis for gene therapy safety studies

4. Global Standard Integration
- Operates under global bioanalytical guidelines (ICH M10, FDA, EMA)
- Connected with Watson LIMS™ for workflow automation and regulatory compliance
- Closely integrated with GCCL’s Central Lab and Bioanalytical Lab for cross-functional synergy

 

Other Products

 

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  Bio Analytical Lab

• 

  Project & Sample Management

• 

  Central Lab Service

 

 

 

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