Immunomodulatory drugs are at the forefront for the treatment of various types of cancer, infectious diseases, and numerous autoimmune diseases, including rheumatoid arthritis, type I diabetes, lupus, and multiple sclerosis. As the complexity of these therapeutics increases, so must the sophistication of the bioanalytical assays designed to either quantify them or measure their impact on the patient.

In Issue 41 of The Altascientist, we explore common classes of immunomodulators, bioanalytical methods used to quantify them, and their associated biomarkers. Featuring two scenarios that explore the complexities of bioanalysis for immunomodulators, The Altascientist offers practical considerations for ensuring accurate bioanalysis, as well as pharmacokinetic, pharmacodynamic, and safety data in clinical trials.

This issue also covers: 
•    classes of immunomodulators, including monoclonal antibodies, CAR-T cells, and vaccines;
•    immunotherapy trials, focusing on complex study designs and diverse patient populations; and
•    bioanalytical methods and assays, including pharmacokinetics and anti-drug antibodies (ADA).

In Issue 40 of The Altascientist, different analytical testing techniques to support drug product development specific to bioavailability are explored, including a case study on the manufacturing of a nanosuspension. 

During the early stages of drug development, fully characterizing the active pharmaceutical ingredients (APIs) is crucial for optimizing the drug product formulation. Specifically, understanding your API’s particle size, crystalline structure (including different polymorph forms), and dissolution profile to inform downstream formulation dosing decisions for clinical trials.

 In this issue of The Altascientist, you will discover: 

• methods for identifying and characterizing your API;
• common techniques to determine particle size distribution (PSD);
• formulation approaches to maximize bioavailability; and
• a nanosuspension case study.