Blog

Improve data quality with better in vivo model welfare. See how stress, environment, and GLP practices impact IND-ready toxicology and PK.

Learn four best practices for developing oligonucleotide therapies targeting CNS disorders, including delivery verification, dual-port administration, tissue sampling, and animal model selection.

The mechanisms of ocular toxicity in ADCs and how to manage them.

ADCs pose significant ocular safety challenges to researchers which can cause costly delays.

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.