Altasciences

Large molecules that have recently emerged in biopharmaceutical drug products are prone to generating unwanted immunogenicity-targeting therapeutic drugs. This can impact their safety and efficacy profile, given the fact that the drug is seen as a foreign entity, despite efforts to humanize the active component. Given the complexity of the molecules, there is a regulatory requirement to evaluate protein-based therapeutic products’ immunogenicity profile. Multiple factors can impact the bioanalysis of the immunogenicity anti-drug antibody assay that characterizes the immune response generated against the drug. Here are three challenges to be aware of while performing ADA assays. Matrix Interference in Immunogenicity Assays One of the most challenging parameters to solve is matrix interference in immunogenicity assays. This is especially true when handling disease-type populations. Multiple factors can contribute to interference, including the disease population and demographic, the rh...

Over the past few years, the drug development landscape has evolved. Where it once emphasized blockbuster drugs that were developed in-house by large pharmaceutical companies, the industry is moving toward a more inclusive paradigm centered on the consumer that includes personalized medicine, orphan drugs for rare diseases, new clinical trial models, and the growing use of contract research organizations (CROs) to manage everything from preclinical studies to clinical trials to bioanalysis and manufacturing. New markets are opening up while cutting-edge treatments are becoming more accessible. Here’s a closer look at some of the trends you might want to keep your eye on.  Personalized and Custom Drugs There has been a growing awareness that the one-size-fits-all medicine model has its limitations. New technologies, such as the ability to sequence DNA, have helped the field of personalized medicine continue to grow. These kinds of custom pharmaceuticals are becoming m...