Metabolic stability is the susceptibility of compounds to biotransformation, which has a major impact on the efficacy and safety of drugs. Here are five assays that evaluate metabolic stability in the drug development process.
Preclinical drug-drug interactions (DDI) studies provide preliminary analysis and predict risk potentials for the investigated compounds when co-administrated with other drugs during future in-human trials. Knowledge pertaining to DDI studies is still rapidly...
In May 2026, US regulators approved vepdegestrant, the first Proteolysis Targeting Chimera (PROTAC) therapy, marking a historic landmark for this drug class. PROTACs offer an exciting and highly promising alternative to traditional small-molecule inhibitors and...
Precision medicine increasingly depends on understanding not just which biomarkers are present in a tissue sample, but how they interact spatially within the disease microenvironment. Conventional pathology methods – including H&E staining, immunohistochemistry...
The implementation of a cohesive biomarker strategy is one of the most critical elements of getting a drug candidate from early discovery through clinical development. A common pitfall, however, is the assumption that the analytical methods used in early research will...
The transition from a lab concept to a viable clinical drug candidate often relies on accurate measures of biological activity. Biomarker assays serve as these essential yardsticks, providing the data necessary to verify target engagement, assess safety, and predict...
Bioanalytical method validation is the process of confirming that an analytical method is accurate, precise, and reliable for its intended use in drug development. It ensures that pharmacokinetic, immunogenicity, and biomarker data meet regulatory expectations for IND...
Bioanalytical services play a critical role in determining whether an Investigational New Drug (IND) application proceeds on schedule or encounters delays. The technical execution of a bioanalytical strategy is a critical contributor to the speed of regulatory...
Transdermal drug delivery is one of the oldest methods of administering medications to humans. These methods can be traced back to the Ancient Egyptians, who used oils, fats, perfumes, and other ingredients to make cosmetic and dermatological products. Yet...
How to deal with toxicology when developing novel therapeutic modalities.
Avoid IND and NDA delays by spotting 5 common DART study pitfalls—CMC drift, timing, weak weight-of-evidence, non-relevant species, and poor clinical translation.
Peptide drug conjugates (PDCs) are rapidly emerging as a versatile alternative to traditional antibody-based therapies. Due to their smaller molecular weight, these molecules offer high specificity and improved tissue penetration, though these advantages come with...
Antibody-Drug Conjugates (ADCs) are among the most complex tools in medicine, pairing the precision of antibodies with the power of small-molecule payloads. Creating effective ADCs, however, requires specialized development support. That’s why it’s so important to...
The emergence of Targeted Protein Degradation (TPD) has been an important shift in drug discovery, serving as a method to reach previously "undruggable" proteins. Proteolysis-Targeting Chimeras (PROTACs) are one type of TPD, which unlike other inhibitors, function...
Optimize drug development with mRNA analytical services. WuXi AppTec’s fit-for-purpose testing strategies are designed to ensure regulatory success.
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.
Peptides present unique safety challenges, with distinct immunogenic potential and tissue distribution patterns that standard testing approaches often miss. What safety assessments cover these gaps?
Complete safety data packages enable confident IND submissions and help researchers avoid safety failures in later development stages
Peptide therapeutics have proven to be a reliable pharmaceutical platform, with a growing record of FDA approvals and commercial success. Yet not every promising candidate makes it to the clinic. The difference? A strategic, three-stage preclinical approach that transforms individual studies into a cohesive regulatory roadmap.