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Antibody-drug conjugates (ADCs) are one of oncology’s most productive modalities because they promise something every drug developer wants: potent tumor destruction with greater selectivity than conventional cytotoxic therapy. As our understanding of ADCs matures, one…

Bioanalytical method development and validation serve distinct yet highly important purposes. Development is the process of establishing an assay’s chemistry and parameters, whereas validation is the formal demonstration that the assay is fit for its intended use….

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…

The transition from discovery to clinical application is among the most volatile (yet important) phases in drug development. The ability to navigate this transition depends on the integrity of the data generated during early-stage evaluations, the period in which…

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.

How skin irritation and corrosion testing based on reconstructed human epidermis models has evolved.

The key safety elements to consider when developing oligonucleotide therapeutics.

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…