Case Studies

When API content drops under accelerated stability conditions and known degradation products don’t account for the loss, development teams need answers quickly. This Ardena application note shows how SOLFORD®, a solid-state degradation technology developed and patented by RD&C, was applied to forced degradation and drug-excipient compatibility screening. The approach confirmed a stability-indicating method and identified […]

Proof of Structure (PoS) is the comprehensive analytical confirmation that a synthesized compound corresponds exactly to its intended chemical identity, including its molecular formula, connectivity, stereochemistry and purity profile. In the pharmaceutical industry, accurate characterization of a molecular structure, including its solid-state identity, is a fundamental requirement that underpins every stage of drug development, from […]

Poor aqueous solubility remains a formidable barrier in drug development, with approximately 90% of new chemical entities facing significant challenges in achieving effective bioavailability. To overcome these limitations, pharmaceutical developers frequently employ solubility enhancement techniques, ranging from particle size reduction to solid-state modifications and advanced formulation-based strategies. At Ardena, our approach emphasizes salt screening, lipid-based […]

A shift to a four-arm, multi-dose Phase IIa protocol introduced new requirements for dosing accuracy, traceability, and patient usability. Learn how Ardena designed a modular secondary packaging solution that integrated existing blister configurations and enabled seamless execution of the updated clinical design.

Long-acting biologics present specific challenges for immunogenicity assessment, particularly when residual drug interferes with ADA detection. In this case study, Ardena outlines how a drug-tolerant ADA assay was established for a high-dose monoclonal antibody, enabling reliable detection in samples with high circulating drug levels. Discover how targeted optimization of a PandA-based approach delivered a robust, […]

Case study A highly promising analog of an endogenous protein was identified as a drug candidate in preclinical studies in rats and monkeys. The sponsor decided to proceed with clinical studies in humans within 10 months, which was a major challenge as the data on immunogenicity required for the regulatory IND filing had to be […]

Case study Drug repurposing has become a rich source of safe and effective new therapeutic options against unmet medical needs.  With the appearance of SARS CoV2 and the pandemic spread of severe Covid-19, drug repurposing has intensively being used to identify potential new drug candidates. One of the potential drug candidates was a small molecule […]

Case study: Building discriminatory power into dissolution testing in late development – a key milestone for the fast product approval Dissolution testing was introduced into pharmaceutical practice after the occurrence of serious side effects of phenytoin after calcium sulfate was replaced by lactose. As a result, the FDA introduced the USP Dissolution type 1 (Basket […]