Antibody-drug conjugates (ADCs) are a crucial part of the new oncology landscape, as they combine the precision of monoclonal antibodies (mAbs) with the potent cytotoxicity of small-molecule drugs. They can deliver a payload directly to target cancer cells, improving efficacy while reducing the risk of off-target effects.
Despite the clinical successes of semaglutide and tirzepatide, many sponsors still encounter persistent bioanalytical challenges when translating GLP‑1 receptor agonists from discovery to clinic.
In vitro toxicology is quickly becoming the most effective way to upgrade drug development and safety programs while staying compliant with evolving regulations. What used to be viewed as “nice-to-have” early screens are now widely used to deliver faster, more human-relevant insight into potential risk, while also reducing reliance on in vivo models. Regulatory bodies worldwide have also urged a shift away from animal studies, prompting drug developers to find new ways to make smarter early decisions, protect timelines, and build clearer, more persuasive safety narratives around their compounds. Here are five ways to align your drug development program with the rapidly evolving expectations of in vitro toxicology.
Immune-modulating therapies, like bispecific T cell engagers (TCEs) and mRNA vaccines can be incredibly effective, but they can also trigger fast, hard-to-predict immune side effects that are costly if uncovered late in the development process. The question every team preparing for Investigational New Drug (IND) applications and first-in-human (FIH) decisions should be asking themselves is simple: How do we create an immunotoxicity strategy that is appropriate for IND submission and still executable on a real timeline?
Peptide therapeutics are among the fastest-growing drug classes in development, but their analytical complexity can become a preclinical bottleneck. At the heart of this challenge lies a critical decision: choosing the right analytical platform.
Peptides fill an uncommon territory in drug development. They’re too large to follow small molecule metabolic pathways but too structurally variable to behave predictably like biologics. Standard DMPK testing frameworks miss the mechanisms that actually determine peptide fate in biological systems—proteolytic degradation, membrane impermeability, and route-dependent distribution patterns that conventional assays weren’t designed to measure.
As vaccine technologies diversify, so too must the strategies for evaluating their safety and efficacy in the preclinical stage. From traditional attenuated and inactivated vaccines to modern mRNA and viral vector platforms, each vaccine type poses distinct bioanalytical considerations that impact how drug developers approach pharmacokinetics, immunogenicity, and safety assessment.
Proteolysis Targeting Chimeras (PROTACs) have brought fresh hope for treating diseases that were previously considered “undruggable.” They offer a promising alternative to traditional small-molecule inhibitors and biologics. But despite the excitement building around the potential of these therapies, preclinical evaluations of PROTACs can present distinct challenges, including pharmacokinetics (PK), pharmacodynamics (PD), safety, and bioanalytical hurdles.
Fusion proteins are a new type of multi-domain artificial protein produced by fusing a biologically active functional protein molecule with other natural proteins (fusion partners) using genetic engineering, chemical modification and other techniques. This can optimize protein performance and even produce new functions. Functional protein molecules are generally endogenous ligands or their receptors, including cytokines, growth factors, hormones, enzymes or peptides and other active substances. Common fusion partners include immunoglobulin (Ig), albumin, transferrin, etc. Among them, fusion proteins based on the fragment crystallizable (Fc) are most widely used.
Small molecule drugs are the most common type of therapeutic on the market. However, that doesn’t mean they are easy to develop. Small molecule preclinical testing is a rigorous and essential process that enables researchers to understand how they behave in and out of the body, including efficacy and toxicity – before they get to human trials. In this guide, we cover everything you need to know about small molecule preclinical testing.
Many of humanity’s most impactful pharmaceuticals, including penicillin and aspirin, are small-molecule drugs. Over time, the focus of research has shifted toward biologics, also known as large-molecule drugs. In 2016, for example, eight of the 10 best-selling drugs in the world were biologics. However, small-molecule drugs are now making a comeback as research advances and technology improves. One key area where small-molecule drugs are making the most significant impact is oncology.
Drug research and development has evolved from focusing only on small molecule drugs into an era of advanced therapeutics. Among the pathogenic proteins related to human diseases, more than 80% belong to non-druggable targets. Meanwhile, most existing druggable targets are restricted by their structure and are difficult to develop.