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Biological Sample Analysis Service

We can provide comprehensive quantitative analytical services for a wide range of in vivo biological samples of small and large molecule drugs and metabolites from preclinical stage to clinical studies in. The service platform is equipped with systematically validated instrumentation and electronic system, including multiple triple quadrupole liquid chromatograph-mass spectrometers. We have completed the analysis of pre-BE samples dozens of projects for various dosage forms, and have established a complete library of validated analytical methods.

The R&D team attended the proficiency testing program held by National Institutes for Food and Drug Control in 2019: Proficiency Testing Program for Determination of Ibuprofen in Rat Plasma Ibuprofen by High Performance Liquid Phase Mass Spectrometry, and in 2020, participated in the External Quality Assessment - Pharmacokinetic Laboratory Biological Sample Detection - Concentration of Carbamazepine in Human Plasma program held by the National Health Commission, receiving satisfactory evaluations.

Service Capability:

◆  Small molecule in vivo drug analysis: including the development and validation of biological sample analytical methods, biological sample analysis, methods that meet the requirements for preparing dossier, validation protocols, analysis plans, validation reports and sample analysis reports, PK parameter statistics, and stable storage of biological samples.

◆  Large molecule in vivo drug analysis: including the development and validation of analytical methods for animal and clinical PK study samples of peptides and protein drugs.

Bioanalysis for Specialized Drug Delivery Systems：

◆  Injectable Liposome Formulation: A comprehensive analytical technology platform for the quantification of free and encapsulated drug components in liposomal products has been established. Core capabilities include: 

 ▫  Stabilizer Development: Developed multiple proprietary and specific stabilizers to maintain the stability of free and encapsulated drugs in biological samples, preventing drug state transformation during sample processing and analysis; 

▫  Separation Technology Platform: Established various high-efficiency separation approaches, including solid-phase extraction and ultrafiltration, to accurately isolate free drug components from biological matrices, providing critical technical support for pharmacokinetic studies and quality evaluation of liposomal products. 

◆  Injectable Albumin-Bound / Protein Nanoparticle Formulation 

 ▫  In Vitro Pharmacokinetic Platform: Focused on characterizing the dynamic binding behaviors and interaction profiles between drugs and albumin/proteins across different biological matrices. 

 ▫  In Vivo Bioanalytical Platform: Designed to address the technical challenges associated with separating free analytes from complex biological matrices in vivo. The platform has successfully developed and validated multiple high-performance separation methods and has extensive experience supporting regulatory submissions. 

◆  PLGA Microspheres / Long-Acting Injectable Formulations / In Situ Gels / Implants / Long-Acting Peptide Formulations: Ain vivo bioanalytical platform dedicated to complex long-acting formulation have been established, with experience supporting more than 50 related projects. 

 ▫  Stability Assurance System: Recognizing that peptides and other biologics are prone to degradation in biological matrices (e.g., whole blood and plasma), Bostal has developed multiple specialized stabilizers to preserve the original drug state prior to analysis, ensuring reliable and accurate bioanalytical results 

 ▫  High-Sensitivity Analytical Method Library: Established more than 30 mature and robust bioanalytical methods with detection sensitivity reaching the picogram (pg) level, which demonstrating excellent accuracy and reproducibility. 

 ▫  End-to-End Bioanalytical Solutions: Provides comprehensive analytical support in compliance with applicable regulatory requirements throughout the entire process, including method development, validation, and sample analysis. 

◆  Endogenous Substance Bioanalysis Platform: Bostal has established a mature bioanalytical platform for endogenous substances, supported by extensive successful project experience and adherence to international regulatory standards. The platform addresses key technical challenges associated with endogenous biomarker and analyte quantification through: 

 ▫  Methodology: Comprehensive expertise in three major analytical strategies, including surrogate matrix methods, background subtraction methods, and analyte replacement approaches

 ▫  Core Resources: Independently developed and validated multiple specialized surrogate matrices to effectively mitigate high background interference and improve analytical reliability. 

 ▫  Service Capabilities: Provides reliable bioanalytical data support for preclinical and clinical studies involving various endogenous substances, including peptide hormones, metabolites, etc.