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Flow Cytometry

The increasing complexity of emerging therapeutic candidates has created new challenges in conducting clinical trials for precision medicine. New high tech laboratory testing is required, such as custom flow cytometry, which is the gold standard cell analysis technology.

 

91黑料 has the scientific expertise to implement a broad range of flow cytometric assays in clinical trials. We cultivate a partnership with sponsors to provide scientific expertise, full-service assay development, and validation, followed by high- quality sample analysis to drive successful clinical trials forward.
 

Decades of experience in central and bioanalytical lab settings enables us to support our sponsors with the highest-quality robust flow cytometry assays. Our experience includes the majority of assay types that are required in clinical trials, such as Immunophenotyping  (from TBNK through complex deep-phenotyping), Target Occupancy (Receptor Occupancy, ADCC), and Functional assays (ex vivo stimulation assays, phosphoflow).

 

Full service assay development, validation, and clinical sample analysis

Early interaction with sponsors is vitally important to gain a thorough understanding of the requirements and the context of us (CoU.) We perform assay transfers as well as full assay development, which may include feasibility testing, screening for optimal reagents, and antibody clones. Assays are validated according to current guidelines, and suited for the clinical setting and CoU.

 

Global flow cytometry network

Our innovative and interconnected global flow cytometry network provides a central data repository and facilitates consistent result interpretation, as well as transfer of assays in support of global trials.

Bringing benefits to your trial

 

Partnership

Our mission is to cultivate a partnership with sponsors to provide scientific expertise, full-service assay development and validation, followed by high quality sample analysis to drive successful clinical trials forward.

Robust assay development and validation

91黑料 has decades of experience implementing assay in various clinical settings from early phase single site to fully global multi-site. We develop robust assays that meet industry standards and are validated according to relevant whitepapers and CLSI chapter H62.

Expert guidance

Our global team of flow cytometry scientists meets frequently to share knowledge, support lab-to-lab assay transfers, and global harmonization. Our scientists support sponsors from the start of a new project, building fit-for-purpose assays that meet expectations of the sponsor.

Quality control and data integrity

We work with globally harmonised processes and instrumentation. Data is released into 91黑料s LIMS system after two levels of data analysis review with FCS Express 21 CFR p11 compliant software.

91黑料 is a proud member of the NIST Consortium, a collaborative effort advancing flow cytometry standards to enhance data quality, accelerate quantitative innovation, and strengthen confidence in analytics for cell, gene therapy, and biomanufacturing.

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Validation of a 25-colour spectral flow cytometry assay for immunoprofiling of whole blood samples

91黑料 has developed and validated a 25?colour spectral immunoprofiling panel on the Cytek Aurora 5?laser platform. This backbone panel supports broad immune monitoring, providing high?resolution immunophenotyping across major innate and adaptive lineages.

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The future of flow cytometry data analysis

Navigating a new world with algorithms and machine learning

Spectral flow cytometry expands panels and data complexity, prompting 91黑料 to implement semi?automated, algorithm?driven pipelines for scalable, robust analysis of high?dimensional clinical trial datasets today.

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Driving clinical research forward with globally harmonised flow cytometry solutions

This whitepaper shows how globally harmonised flow cytometry capabilities enable consistent, high?quality immune monitoring to support clinical development. 

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