Drug Development Pathway & Our Service
• CDMO and/or CRO service
• Mammalian or Microbial cell line and process development
(CHO and E. coli and Yeast)
• VLP based vaccine development
• Analytical method development & validation
• Tech. transfer and scale up for GMP manufacturing
• Contract manufacturing of DS
• Formulation development service
• Analytical method development & validation
• DP stability study
• GMP batch releasing test for DP
• Medical Device related service
• Concept design
• Custom requested service
• Extractables and Leachables study
(ISO10993, USP1663, USP1664, USP665, USP1665, BPOG, PQRI, PIC/s)
• Risk assessment
• Organic carbon identification
• Toxicological assessment
• Impurity and Identification
• Container Closure Integrity Testing (CCIT)
• Particles & foreign matter investigation
• Nitrosamine, Teflon residues , Rubricants, PFAS
• Genotoxic Impurities analysis and Elemental Impurites analysis
• Pharmaceutical Impurity Testing and Identification Analysis
• Pharmaceutical analysis support
• GMP cell banking & characterization
( CHO or E.coil or yeast etc.. )
• Bioassay for lot release (in vitro & in vivo)
• Translational studies, Biomarkers, clinical PK, PD and ADA analysis (by Synexa)
• Sanger Sequencing for lot release of nucleic acid based therapeutics
• GMP storage service
• GMP cell bank storage service
(주)큐비디는 Biopharmaceuticals, Pharmaceuticals, Food & Beverage, Semiconductor, Chemical manufacturing을 위한 최첨단 기술, 도구 및 서비스를 제공하는 업체입니다. 우리는 전세계의 도전적인 산업 문제에 대처하기 위해 고객과 협력합니다. Extractables and Leachables study, Virus clearance study, Cell line development, Cell Banking, Process development, Lab scale production of Active BioPharmaceutical Ingredients(rProtein, enzyme, etc), Analytical Services 등을 전문으로 하는 서비스 회사 입니다.
Quality by Design Inc. is a service provider providing cutting-edge technologies, tools, and services for Biopharmaceuticals, Pharmaceuticals, Food&Beverage, Semiconductor, Chemical manufacturing. we collaborate with customers to confront the world's challenging industrial issues. Quality by Design Inc. is a company specialized in Extractables and Leachables study, Virus clearance study, Cell line development, Cell Banking, Process development, Lab scale production of Active BioPharmaceutical Ingredients(rProtein, enzyme, etc), Analytical Services, etc. for clients in the biopharmaceutical, veterinary and life science industry.