With an experienced bioanalysis team, advanced analytical instruments, whole-process electronic management, and reliable GLP quality control system, JOINN Analysis and Bioanalysis Department provides high-quality customized bioanalytical services from preclinical, IND-enabling and NDA application, covering small molecule drugs, monoclonal antibodies, bispecific antibodies, antibody-drug conjugates, enzymes, cell and gene therapies, and vaccines, etc, biomarkers, immunogenicity, and cell-based assays.
We have built a full-spectrum technical platform compatible with small molecules, biomacromolecules, ADCs and oligonucleotide therapeutics, capable of undertaking a comprehensive range of new drug projects including in vivo PK/TK studies, metabolite identification, impurity testing and elemental metal analysis.
•Sciex Triple Quad™ 7500 (3 units)
•Sciex Triple Quad™ 6500+ (5 units)
•Sciex Triple Quad™ 6500 (5 units)
•Sciex Triple Quad™ 5500 (10 units)
•API 4000 (4 units)
•Shimadzu LC-MS-8050 (4 units)
•Waters TQD (1 unit)
•Waters TQS (4 units)
•Agilent ICP‑MS (2 units)
•Sciex Triple TOF (2 units)
We fully implement ICH M10 guidelines to complete full-dimensional validation covering specificity, sensitivity, precision, accuracy, stability and matrix effects.
Species selection is determined by combining drug target profiles, metabolic characteristics and therapeutic indications via preliminary in vitro screening: small-molecule drugs commonly utilize rats and Beagle dogs; large-molecule and novel advanced therapies prioritize non-human primates; pediatric therapeutics require dedicated juvenile animal studies to ensure data extrapolability to human subjects.
Preclinical PK programs for small-molecule drugs require approximately 2–3 months, while programs for large-molecule/cell-gene therapeutics take roughly 3–4 months. Deliverables include full study protocols, method validation reports, raw study data, PK parameter analysis reports and bilingual Chinese-English registration summary reports. We provide full support for inspection inquiries throughout the project lifecycle.
Yes. Our study systems and data management workflows comply with requirements of all major global regulatory authorities. We provide bilingual registration reports with internationally mutually acceptable data to support concurrent multi-jurisdictional registration filings.
We operate a full-lifecycle sample traceability system with tiered temperature-controlled storage, barcode registration and real-time monitoring. Redundant backup and alarm systems are deployed to eliminate risks of sample degradation, loss or cross-contamination.
