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Bioanalysis


Bioanalysis

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Our bioanalytical laboratory provides chromatographic and ligand binding analysis in support of IND, NDA and ANDA packages. With ~75,000 ft2 of lab space and 200 qualified scientists with expertise in both small and large molecule bioanalysis, we are the largest bioanalytical laboratory in Asia and the 1st to pass inspections by the USFDA, CFDA, OECD, and EMA. We also offer GLP-like services for small molecule analysis in support of DMPK which maintains 38 LC systems and 28 mass spectrometers with 16 dedicated to in vivo PK samples and 12 dedicated to in vitro sample analysis. We are also the largest bioanalytical facility in Asia for large molecule therapeutics. We can validate methods for your novel biologics or we also have validated free-to-use methods for the top large-molecule therapeutics to expedite our partners' biosimilar projects.

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Small Molecule GLP/GCP Bioanalysis

  • US FDA/OECD/EMA/CFDA inspected
  • Method development/transfer/validation
  • Over 150 non- proprietary methods free-to-use
  • Drug quantitation in biological matrices (can achieve low pg/mL LLOQs with an API 6500)

Ultrasensitive Small Molecule Quantitation

Chemical structures of mometasone furoate and mometasone furoate-D3

BAS 6-fixed

Representative results of assay accuracy and precision

BAS 8-FIXED

Representative chromatogram of the LLOQ sample of  mometasone furoate in human plasma

BAS 10-FIXED

Proposed transesterification reaction of Isradipine-D6 with methanol

BAS 7-FIXED

Representative results of assay accuracy and precision

BAS 9-FIXED

Representative chromatogram of the LLOQ sample of  Isradipine in human plasma

BAS 11-FIXED

Large Molecule GLP/GCP Bioanalysis

  • Immunogen and customized antibody preparation
  • Assay development/transfer and validation
  • Validating assays for top biosimilars to eliminate lead time
  • Drug and biomarker quantitation in biological matrices
  • ADA/Nab assay
  • Examining the potential to validate analytical methods for LC-MS/MS

Small Molecule Non-GLP Bioanalysis

  • Fast and sensitive LC-MS/MS systems including UPLCs , LEAP CTC Analytics PAL and Gilson coupled with API 5500, 4000, 3000 Triple Quads, and 4000 Q-Trap
  • Automated sample handling systems including Beckman Biomek FX, Eppendorf epMotion, and Apricot Designs IPB-96-500
  • High Throughput Screening for ADME (2,600 samples/day/LC-MS system)
  • Dedicated instrument maintenance team and project-dedicated QC team
  • Successfully passed all our client-initiated data validations including audits from most of top 20 pharmaceutical companies