Toxicity

Assessment of injection site reactionsA new proprietary research tool to identify drug-related immune adverse reactions in human skinToday, biologics represent one of the fastest growing markets within the pharmaceutical industry.The pipeline of biological drugs is growing at a rapid pace with a global market expected to reach over 460 billion USD in 2024 (1). In order to bypass gastric metabolism,Read more

Navigating Unwanted ImmunogenicityPart 3 - Challenges & insights in biologic drug developmentOver the past two and a half decades, biologics development has been growing exponentially, matching the pace of small molecules development in 20221. Biologics, or biopharmaceutical products, encompass a wide range of therapeutic products such as vaccines, monoclonal antibodies, gene and cell therapy, and recombinant and fusion therapeutic proteins.Read more

Transforming Drug SafetyThe Revolutionary Role of Investigative Toxicology in Drug DevelopmentIn an era where the pace of pharmaceutical innovation is rapidly evolving, the field of toxicology is undergoing a transformative shift. This goes beyond subtle changes; there is a fundamental reimagining of its role from observing drug-induced effects to proactively shaping drug safety measures.The Integration of Investigative Toxicology The traditionalRead more

Understanding Local Tolerancein Drug DevelopmentIn the ever-evolving field of drug development, ensuring the safety and efficacy of new therapeutic agents is paramount. A crucial aspect of this safety evaluation is the assessment of cytotoxicity – the potential of substances to harm or destroy cells. Particularly in the realm of skin cytotoxicity, the concept of Local Tolerance, especially in the contextRead more

Immunogenicity SeriesPart 1 - Defining immunogenicity Immunogenicity plays a pivotal role in drug and vaccine development and is essential for optimizing therapeutic efficacy and safetyby understanding the immune system's response to the compounds being tested. This is particularly crucial in the era of biologics and personalized medicine, where the fine balance between therapeutic benefit and immune reactivity is critical. WhetherRead more

Redefining Local Toxicity AssessmentPart 2 - The Role of Animal-Free Non-Clinical Platforms in Drug Development. In the realm of non-clinical animal-free platforms, a transformative shift is unfolding in response to the challenges posed by drug-induced adverse reactionsa predominant factor leading to the discontinuation of drug development projects and the withdrawal of drugs from the market1. The imperative for accurate, ethical,Read more