Customized, One-Stop Bioanalysis Services
Our expert team in bioanalysis and biomarkers has extensive experience across a wide range of therapeutic areas.
SDM Bioservices provides expert bioanalysis and biomarker services with extensive experience across various therapeutic areas.
We operate two GLP-compliant bioanalysis labs in Beijing and Hangzhou, China, offering one-stop clinical sample analysis for pharmaceutical companies, CROs, and research institutions globally. Our team specializes in method development, validation, sample analysis, and regulatory submissions, covering non-clinical and clinical development services such as PK/PD analysis, immunogenicity assessments, and biomarker testing. We handle a wide range of product types, including vaccines, small and large molecule compounds, monoclonal antibodies (mAb), ADCs, cell and gene therapies, traditional Chinese medicine and more.
With advanced technology platforms (immunoassays, cell assays, mass spectrometry, molecular analysis, flow cytometry, and ELISpot), we ensure high-quality results while adhering to GLP/GCP standards. We have supported global regulatory submissions and specialize in sample import/export thanks to Amador laboratory being qualified on “White Name List” in Zhejiang Province.
Vaccine Analysis
We offer comprehensive, compliant bioanalysis services for various clinical vaccine studies, having developed and validated numerous analytical methods, with custom method development options available.
LC-MS/MS
Using high-resolution and triple quadrupole mass spectrometry (LC-MS/MS) to measure ADCs, oligonucleotides, peptides, small molecules, biomarkers, PTOTACs, and more.
PK/PD Analysis
Our deep understanding of biology and target mechanisms allows us to develop analytical methods for various biotechnological drugs. Our services support both non-clinical and clinical studies, helping sponsors understand the pharmacokinetics and pharmacodynamics of drugs in vivo.
Immunogenicity
Using multiplex and ultra-sensitive assays such as ELISA, MSD, Gyrolab, Luminex, and SPX, we conduct protein/oligonucleotide therapies, biomarker, and anti-drug antibody (ADA) analysis.
Biomarkers
We have extensive experience in detecting biomarkers like inflammatory cytokines, chemokines, and vascular endothelial growth factors (VEGF). Our biomarker analysis platforms for proteins and cells offer high sensitivity and specificity for multi-analyte testing, aiding sponsors in biomarker discovery.
Biological Sample Management
We manage the full lifecycle of biological samples through Watson LIMS, ensuring regulatory compliance at every stage—from collection and transportation to storage, use, and disposal. Our system allows for complete audit tracking to guarantee sample safety.
Customized Method Development
Our team specializes in developing methods for emerging drug types and new technologies. We quickly adapt to the evolving needs of the biopharma industry, providing customized solutions for analytical method development.
Comprehensive Expertise and Technical Experience
With broad expertise in drug development and technical capabilities, we handle complex method transfers or method development and generate tailored reports for preclinical and clinical phases. Our core team members bring years of experience, enabling us to design bioanalysis strategies that align with the specific stages of your drug development process.
Comprehensive Immunogenicity Assessment for New Drug Market Approval
Our immunogenicity evaluation system includes technologies for assessing both humoral and cellular immunity, as well as pathogen microorganism testing. We offer a comprehensive solution including:
• Immunogenicity risk assessment and clinical immunogenicity strategies
• Development and validation of testing methods
• Sample testing (anti-drug antibody screening, confirmation, titration, neutralization, epitope specificity, allogeneic responses)
• Data analysis in clinical development (impact of ADAs on pharmacokinetics/pharmacodynamics, efficacy, and adverse reactions)
• Regulatory submission documents (e.g., integrated immunogenicity summary, 2.7.1, 2.7.2, CSR, etc.)
• Immunogenicity risk assessment and clinical immunogenicity strategies
• Development and validation of testing methods
• Sample testing (anti-drug antibody screening, confirmation, titration, neutralization, epitope specificity, allogeneic responses)
• Data analysis in clinical development (impact of ADAs on pharmacokinetics/pharmacodynamics, efficacy, and adverse reactions)
• Regulatory submission documents (e.g., integrated immunogenicity summary, 2.7.1, 2.7.2, CSR, etc.)
Integrated Support for Clinical Development
With nearly 20 years of experience in clinical development services, SDM Bioservices provides one-stop support for drug clinical development, improving communication and coordination to enhance project execution and delivery. We accelerate timelines and assist with product commercialization.
Key Equipment and Instruments
We excel in providing bioanalysis solutions that require innovative thinking. Our comprehensive services are focused on customization, ensuring smooth transitions through each phase of your drug development.
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