Cell and Gene Therapies (CGTs) has an estimated market size value in 2022 of USD 8.22 billion and a revenue forecast in 2030 of USD 24.5 billion. This is a CAGR (compound annual growth rate) of 14.6% from 2022 to 2030. Needless to say, the…

Due to its ability to analyze multiple parameters across different cell types within a sample, flow cytometry provides rich and clinically valuable data sets from even small volumes of blood. However, flow cytometry is a challenging platform to master, and requires significant investment in equipment and technical training.

With the extensive advances in technologies like CRISPR and CAR-T, cell and gene therapy has grown to become a viable way for treating Cancer as well as other diseases. Our team has over 100+ years of collective expertise in molecular services using qPCR and ddPCR for support of…

Many flow cytometry users are happy to start an experiment with a general protocol and a question about their specimen -- Will my cells make more cytokines or express more markers after activation? Will my cells respond to a novel immunotherapeutic drug candidate?

Immunotherapy research is a rapidly expanding field with a pipeline of monoclonal antibodies in development to treat a range of cancers and autoimmune diseases. The mechanism of action (MOA) used by an antibody to mediate a therapeutic response must be fully defined to enable a candidate antibody to advance down the preclinical development pipeline. It is also required for all antibodies used in clinical research and regulatory IND filings in order to optimize dosing and assess the risk of detrimental side effects.

Drugs and biologics in the research pipeline must undergo stringent preclinical toxicology and safety assessments before use in a clinical trial. Most traditional preclinical toxicology screenings include testing in animal models in order to define toxicological and pharmacological parameters that are critical to determining appropriate dosing such as maximum tolerated dose (MTD).

Toxicology screening is essential to any preclinical study, and flow cytometry-based toxicology assays are a fast and practical approach. Different animal models are used for toxicology studies, including rodents, dogs and non-human primates. One commonly used technique is the micronucleated erythrocyte endpoint assay, which measures DNA damage induced by exposure to experimental drugs or biologics. This method has been adapted into a validated flow cytometry-based assay and can use erythrocytes from different species. Consider these factors when selecting the best toxicology screening method.

Flow cytometry has been developed and used as a clinical tool since the invention of the first cytometers in the 1970s. At present, flow cytometry is considered essential for many routine clinical diagnostics, including assays for leukemia and lymphoma, stem cell enumeration, solid organ transplantation, HIV infection status, immunodeficiencies, and hematologic abnormalities. Many scientists involved in clinical trials or drug development are faced with developing clinical flow cytometry assays for multiple phases of clinical development. If you find yourself starting to plan a clinical flow cytometry assay, here are the top 3 issues to think about as you plan your experiment.

Many basic and clinical immunology studies that focus on T cells include proliferation assays in order to determine if T cells are capable of proliferating under different in vitro or in vivo conditions. Flow cytometry is the ideal approach for measuring T cell proliferation and a suite of staining products…

Anyone who starts an investigation of acute myeloid leukemia (AML) soon finds out the complexity of this disease. Although daunting initially, it soon becomes apparent the need for complex classifications for AML subtypes and different mechanisms for formation. AML forms from a wide variety of DNA mutations leading to numerous phenotypic changes in the blood makeup. Early on there were the French-American-British classifications in the 1970s (FAB) but in present day, AML type is being broken down to genetic markers. For the most part, this is due to the advancement of scientific-technical capability. Conversely, being able to clearly define AML by mechanistic function, allows for clinicians to state, with some certainty, treatment and survival options for their patients.

Flow cytometry is an elegant and powerful tool that has been critical to understanding the immune system and advancing the development of immune-based therapies. Critical to many studies, and essential for FDA filings, is the development and documentation of a validated assay. While most flow cytometric assays fall into the “quasi-quantitative” category according to FDA guidelines, there are some assays that can be quantitative and even qualitative.