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Bioanalysis of Large Molecules, Complex Biologics, and Advanced Therapies

Expertise in bioanalysis for complex preclinical and clinical studies

At Precision, we comprehend the complexities of immunogenicity testing and other bioanalytical methods. Our leadership team continues to shape and inform regulatory guidance. We offer a broad range of bioanalytical services, including the analysis of CAR T-cell immunogenicity, drug-specific IgE assays, antibody detection assays for gene therapy, and CLIA-validated companion diagnostics (CDx). Furthermore, we support the implementation of assays for PEGylated proteins, ADCs, and bispecifics.

Areas of bioanalytical research expertise

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    Immunogenicity

    Specializing in challenging immunogenicity projects, such as the evaluation of multi-domain proteins, PEGylated proteins, complement activation, and immunogenicity of CAR-T and gene therapies
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    Large Molecule PK

    Development, validation, and implementation using ELISAs and MSD assays for biologics, flow cytometry and ddPCR for cell-based therapies, and Quanterix SIMOA® for ultrasensitive analyte detection
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    NAb & TAb Assays

    Leveraging multiple approaches for the development of neutralizing antibody assays (NAb) and total antibody (TAb) assays including ELISA, MesoScale, and Biacore, with the capability to develop these assays into CDx
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  • Technologies enabling large molecule bioanalytical research

    We leverage established technologies, proprietary approaches, and develop and validate biomarker assays to generate robust biomarker data in samples ranging from nucleic acids to tissues

  • Meso Scale Discovery (MSD)

    Measuring a range of analytes in complex sample matrices consistently and at high sensitivity, with applications including ADA, NAb, TAb, and PK assays
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  • Quanterix SIMOA®

    Precise quantification of analytes in multiple matrices at sensitivity down to femtomolar (fM) levels, enabling analysis of analytes that may have been previously undetectable

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  • ELISA

    Services using the gold standard for quantitative antibody-based bioanalysis, with specialization in immunogenicity assay development
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  • Olink® Proteomics

    High-multiplex quantification of protein biomarkers with minimal clinical sample volume and exceptional sensitivity and specificity

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Bioanalysis experience overview

Explore the therapeutic types and assays that we have helped sponsors advance.

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Bioanalysis Assay Experience

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Bioanalysis Assay Experience
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Bioanalysis scientific and technical expertise

Precision for Medicine is capable of evaluating the pharmacokinetic and pharmacodynamic properties of potential biotherapeutics, including their immunogenicity. This supports IND-enabling nonclinical studies and all clinical trial phases. 

We can suggest and provide the best assays based on the development stage and risk profile, ensuring regulatory requirements are met under a robust quality system. This includes supporting the co-development of neutralizing antibody assays for AAV-based gene therapy as companion diagnostics. Our services cater to a broad range of indications, including Oncology, Rare Disease, and Gastroenterology.

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Bioanalytical assays supporting gene and cell therapies

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Accompanied by comprehensive regulatory consulting

Precision for Medicine is a regulatory leader in industry with expertise in emerging fields, including gene therapy CDx, with extensive knowledge in NAb and TAb assay development, supporting 14 different rare disease pipelines. Globally situated, Precision can conduct testing in laboratories in both US and Germany.

With 125+ years of cumulative IVD regulatory experience, our team provides end-to-end regulatory solutions and support with industry knowledge developing global regulatory strategies, CLIA- and CLSI-compliant analytical validation study designs, and clinical trials enabling regulatory submissions, in addition to marketing authorization regulatory filings globally.