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Expert perspectives focused on the latest bioanalytical topic & trends

How Have Advanced Drug Modalities Impacted Bioanalysis?

As therapeutic drugs have grown in complexity, so too have the bioanalysis techniques to support these products. Bioanalysis of small molecule drugs has become more routine over time with the accumulation of experience gained through decades of work. The advent of large molecule therapeutics ushered in all new challenges as protein-based immunoassays became the norm. These assays tend

Neoantigens Revive Vaccine Opportunities in Immuno-Oncology

Neoantigens are novel proteins that form on cancer cells following the development of mutations in the tumor-cell DNA. These proteins are new to the immune system and are not part of the collection of self-proteins to which immune cells are tolerant or non-responsive. Therefore, neoantigens have the ability to trigger an impressive and very specific

Multiplexed Cytokine Analysis in Drug Development

Cytokines are proteins released by activated cells that serve as soluble messengers binding to target cells through surface receptors, signaling functional responses. The nature of cytokines is pleiotropic; a single cytokine can elicit varying responses in different cell types. Often, cytokines are produced as a part of a cascade wherein one cytokine causes the targeted

Determining Immunogenicity for CAR-T cell Therapies

Chimeric Antigen Receptor (CAR)-T cell therapy is a novel cancer therapy that harnesses and redirects the cytotoxic activity of T cells against cancer cells. CAR-T cells are generated by engineering T cells to express a chimeric antigen receptor, which is typically an antibody directed against a target on the cancer cell, fused with TCR signaling

The Importance Of GMP Certification In Drug Development

Production and sale of therapeutic drugs requires tight control over the manufacturing, processing, and labeling of these products to ensure the safety of the end user. In the United States, regulations for maintaining the quality of medications such as these are under the jurisdiction of the Food and Drug Administration (FDA). They are referred to

Is ISR Needed For Biomarker Assays?

Incurred sample reanalysis (ISR) is a well-established measure for the reproducibility of pharmacokinetic (PK) assays and commonly conducted in regulated studies. ISR was established in PK assays to address sources irreproducibility observed in study data that could be attributed to back conversion of unstable metabolites, matrix effects, recovery issues, sample inhomogeneity and undocumented technical errors.

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