Bioanalytical Package
- Service Details
- Features
- FAQ
- Explore Other Options
Creative Bioarray's Bioanalytical Package is designed to provide efficient, precise, and regulatory-compliant bioanalytical solutions for your innovative drug discovery and development programs.
Accurate and reliable quantification of a drug and its metabolites in biological matrices is a critical step in preclinical development. This data is essential for assessing a drug's pharmacokinetics (PK), pharmacodynamics (PD), and toxicokinetics (TK) properties, and is a cornerstone of a successful Investigational New Drug (IND) application. Our Bioanalytical Package integrates a variety of advanced technology platforms with extensive project experience to deliver a comprehensive and high-quality one-stop service.
Our Services
Our Bioanalytical Package offers end-to-end support tailored to different development stages:
Method Development
We develop sensitive and specific analytical methods for small molecules, biologics, peptides, nucleic acids, gene therapy, etc. for quantification and characterization of your analyte at any stage of development.
Method Validation
Validation of methods following stringent standards as per FDA, EMA, ICH, etc.
GLP/Non-GLP Bioanalysis
Our Bioanalysis services include both GLP-compliant studies for regulatory submissions and flexible non-GLP options tailored for early-stage research development.
PK/TK Studies
Our PK/TK services are focused on quantification of drugs and metabolites in biological matrices like plasma, urine, tissues and other biofluids to obtain accurate, reproducible data on drug disposition and safety.
Immunogenicity Assessment
Detection of anti-drug antibodies (ADA) and neutralizing antibodies (NAb).
Biomarker Analysis
We conduct detailed quantitative and qualitative analyses of biomarkers to support mechanism-of-action studies, efficacy evaluations, and the identification of relevant biological targets or pathways, enabling a deeper understanding of drug performance.
Technology Platforms
We leverage a diverse range of technology platforms to handle a wide variety of molecule types and complex biological matrices.
Mass Spectrometry
LC-MS/MS (Liquid Chromatography–Tandem Mass Spectrometry) is the primary platform for the analysis of small molecules and peptides. It offers unmatched sensitivity and specificity for accurate quantification.
Immunoassay
Platforms like ELISA and MSD are used for quantitative analysis of biologics (e.g., antibodies, recombinant proteins) and biomarkers.
Flow Cytometry
FACS (Fluorescence-Activated Cell Sorting) is utilized for cell counting, phenotyping, and efficacy assessment of cell therapy products like CAR-T.
Molecular Biology
Technologies like qPCR (Quantitative Polymerase Chain Reaction) are used for the quantification of nucleic acid therapeutics (e.g., siRNA, mRNA) and gene expression analysis.
Molecule Types
Our bioanalytical expertise spans across multiple therapeutic modalities, including:
- Small molecules
- Peptides and oligonucleotides
- Biologics (proteins, monoclonal antibodies, biosimilars)
- Nucleic acid-based drugs (mRNA, siRNA, ASOs)
- Cell and gene therapy-related analytes
Key Features
Proven Expertise
Experienced scientists with deep knowledge of regulatory requirements.
Tailored Solutions
Customized workflows designed to meet specific project needs.
Efficiency
Streamlined processes to accelerate timelines without compromising quality.
Comprehensive Support
One-stop bioanalytical services from preclinical to clinical phases.
FAQ
What biological matrices can you analyze?
We routinely analyze matrices beyond standard plasma and serum, such as tissue homogenates, CSF, vitreous humor, bile, urine, feces and other biological fluids and matrices, with special expertise in the analysis of limited-volume samples.
How do you ensure data accuracy and reliability?
Our rigorous quality control system includes double-blind sample analysis, regular instrument calibration, QC sample monitoring, and other measures to ensure data quality meets regulatory standards.
What report formats do you provide?
Reports will be prepared in accordance with requirements of the major regulatory agencies. Electronic and hardcopy formats are available and can be customized for content and presentation.
What information is needed to get a project started?
We recommend providing compound structure, physicochemical properties, expected concentration ranges, and availability of reference standards to facilitate feasibility assessment and optimal study design.
Explore Other Options
