Hamburg, Germany Lab Expertise

Lab Services to Support Customer Drug Development from Early Phase to Market Authorization

BioAgilytix’s advanced laboratory in Hamburg, Germany, serves as our European headquarters where we offer global customers a wide range of services, technologies, and expertise for bioanalytical support of investigative therapeutics. The recent laboratory expansion has enhanced our footprint in the European market, adding to our repertoire of state-of-the-art equipment and bolstering our resources for delivering top-notch scientific services.

We provide analytical support for companies from emerging biotech to large pharma, which includes compliance with GLP and GCP standards, as well as GMP certification. Our focus is to provide phase-appropriate, scientifically sound solutions for every stage of drug development with dedicated project management support to help our customers get therapeutics to approval faster.

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Bioanalytical Laboratory Services

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Pharmacokinetics

BioAgilytix provides PK assay development, validation, and sample testing, as well as PK analysis and reporting to support all drug modalities at any phase of development. Our site in Hamburg is equipped with the latest instrumentation and technologies for a wide range of methods, allowing us to provide custom scientific solutions to fit each of our customer’s unique PK assay needs.

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Immunogenicity

Assessing a therapeutic’s immunogenicity is a key step in drug development. Our scientific teams in Hamburg have extensive expertise in the development and implementation of immunogenicity assays, including anti-drug antibody (ADA) or neutralizing antibody (NAb) assays as well as cellular immunogenicity assessments.

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Biomarkers

We offer an extensive menu of biomarker assay services from validated, ready-to-use methods to de novo assay development. Our biomarker capabilities include a variety of platforms and techniques, can be single or multiplexed, and can be qualified or validated according to the intended purpose.

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CMC Bioanalytical

Chemistry, Manufacturing, and Controls (CMC) is a crucial part of the drug development and manufacturing process to ensure consistent safety, efficacy, and quality of pharmaceutical products. Our European facility is GMP-certified and specializes in providing cell-based CMC potency assays in support of lot release and stability testing of therapeutics.

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Off-the-shelf assays

Off-the-shelf assays that are in place and available for rapid implementation in regulated or nonregulated sample analysis directly translate into faster timelines and reduced costs for our customers. We offer an extensive list of biomarkers as well as anti-drug antibody (ADA) and neutralizing antibody (NAb) assays that have been qualified or validated in various matrices and are ready for sample analysis. View our off-the-shelf assay menu.

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BioAgilytix Expands Hamburg Lab to Support Customer Drug Development from Early Phase to Market Authorization

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State-of-the-art platforms for large molecule bioanalysis

We maintain an extensive suite of instrumentation at our Hamburg facility to ensure we can meet our customer’s wide-ranging bioanalytical needs. Some of our commonly utilized platforms in large molecule bioanalysis include: