Case studies - Page

Our team has validated the SIMOA NF-Light Advantage Kit from Quanterix, evaluating its performance in terms of dynamic
range, precision, parallelism, selectivity, and stability in both blood and CSF samples. These methods have been used for
monitoring NfL in plasma and CSF from patients participating to a clinical study evaluating an innovative antibody-based therapy
for Alzheimer’s disease (AD).

Want to learn more? Read our case study!

Administration of antibody-based drug products by intravenous route requires dilution to low concentrations in i.v. solutions. At concentrations below 0.5 mg/mL, adsorption of biotherapeutics on plastic polymer injection devices such as i.v. bags, tubing and syringes may be substantial, leading to decrease by up to 40% at concentrations as low as 0.01 mg/mL when diluted in normal saline1.

So how to make sure that subjects consistently receive the desired dose?

Check our case study and don't hesitate to reach out to our expert team should you have any question.

Most if not all vaccine candidates need robust methods to monitor their specific immunogenicity.

But clinical trial constraints as well as sample quality often make it challenging to achieve efficiently this objective.

Check our contribution to reducing ELISPOT assay variability.

Discover our comprehensive bioanalytical toolbox to support the development of therapeutic antibodies. From PK study design to immunogenicity assessment or biomarker testing. Check this out !

Active Biomarkers has decades of experience in bioanalytical services We have a proven track record supporting the development of key players'
preventive and therapeutic vaccines in both preclinical and clinical phases. Check what we can do for you!

Understanding how an investigational product modulates the immune system is of outstanding value in many therapeutic areas and indications. The enzyme-linked
immunosorbent spot (ELISpot) assay was firstly developed more than 30 years ago for the detection of antibody-secreting cells1,2. Since then, this method has become one of the most popular for documenting functionality of antigen-specific T cell responses in the context of therapies expected to modulate the immune system, such as preventive or therapeutic, universal or individualized vaccines, but also therapeutic antibodies, immune check-point inhibitors or oncolytic viral therapies, in many fields, including immuno-oncology, infectious diseases, autoimmunity, (neuro)inflammation or allergy.

If there are indisputable advantages (sensitivity, measure of cell function, low-cost assay) of the ELISpot assay for evaluating cell-mediated immunogenicity in large-scale
clinical trials, many factors, if not under control, may affect assay performance and outcomes.