Laboratory Profile: Testing Facility for Biological Safety (TFBS) of Development Center for Biotechnology

Testing Facility for Biological Safety (TFBS) of Development Center for Biotechnology Services :

Preclinical development efforts ranging from medicinal chemistry and lead optimization to pharmacology and safety studies. Pharmaceutical Testing, Biopharmaceutical Testing, Biologics Testing: (1) Cell Bank Characterization (2) Biological Safety Testing (3) Bulk & Lot Release (4) Process Validation Studies of Viral Clearance (5) Cell-based Assays and (6) Clinical Sample Analysis.

Our service list are (1) Molecular Biology: -Genetic Stability -Determination of Copy No. -DNA Sequencing -Detection of Residual DNA (2) Virology: -Virus Clearance Validation -Adventitious Virus Detection -Retrovirus Detection -TEM -Virus Seed Characterization (3) Cell Bank Characterization -Prokaryotic ƒÞ Identity of organism ƒÞ Identity of plasmid ƒÞ Purity ƒÞ Sterility ƒÞ Genetic Stability -Eukaryotic ƒÞ Identity ƒÞ Purity ƒÞ Genetic Stability (4) Bioassay -Method ƒÞ Development ƒÞ Validation ƒÞ Optimization ƒÞ Transfer -Lot Release Test ƒÞ Residual DNA ƒÞ Host Cell Protein ƒÞ Endotoxin ƒÞ Bioburden or Sterility -Other ƒÞ Tumorgenicity ƒÞ Oncogenicity Pharmacokinetic (PK) Toxicokinetic (TK) ƒÞ Immunogenicity (e.g. ADA, Neutralization, etc.) ƒÞ Custom Assays (e.g.Potency, etc.)

Those services provided by TFBS have the following features: (1) Adherence to international regulatory requirements and guidelines such as International Conference on Harmonisation (ICH), US Food and Drug Administration (FDA), European Medicines Agency (EMA), etc. (2) GLP quality systems: Compliance with GLP guidelines of TFDA, U.S. FDA and OECD etc. (3) Quick response and timely delivery (4) Customized product testing and assay validation services (5) Regulatory consultation service (6) Alliance with domestic and international collaborative partners to accelerate product commercialization process (7) Affiliation with DCB¡¦s R&D, testing and manufacturing capabilities to provide integrated services for development and testing of biopharmaceuticals

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