Bio Analytical Lab

 

Model: Analytical services

Category: *CRO

Exhibitor: GCCL CO., LTD.

Booth No: N/A

 

Characteristic

 

GCCL’s Bioanalytical Laboratory provides high-quality analytical services across all phases of drug development, specializing in biologics, biosimilars, and cell & gene therapies.

1. End-to-End Bioanalytical Services
- Method development and validation (ICH M10, FDA, EMA, CLSI guidelines)
- Pharmacokinetics (PK), Pharmacodynamics (PD), Immunogenicity (ADA, NAb)
- Biomarker discovery and multiplex profiling
- Support for small molecules, biologics, and gene therapies

2. Advanced Analytical Platforms
- LBA (ELISA, MSD, SIMOA), LC-MS/MS, ddPCR, qPCR
- Flow Cytometry, Spectral FACS, ELISpot, Multiplex IHC
- High-sensitivity assays for CNS and infectious diseases

3. Regulatory-Ready Data Management
- Watson LIMS™ ensures global compliance and traceability
- Automation of data collection to minimize errors and improve audit readiness
- Structured reports for regulatory submissions (NDA/BLA)

4. Specialized Expertise & Facilities
- BL2/BL3 facilities for viral neutralization and infectious disease testing
- In-house virus culture for assay development (e.g., RSV, Influenza, SARS-CoV-2)
- Dedicated team with extensive experience in oncology, CNS, and vaccines

 

Other Products

 

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  Project & Sample Management

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  Central Lab Service

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  Research & Development Services

 

 

 

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