Expert Insights

Ardena’s first nanomedicine symposium brings together leading scientists, clinicians, and industry experts to discuss the latest advances in nanomedicine and ADC development.

Join Ardena at World ADC London Europe, taking place February 24–25 in London, UK. This premier event unites leaders and experts in the ADC and targeted therapy field to share scientific insights, showcase cutting-edge technologies, and explore current trends shaping antibody-drug conjugates and bioconjugates across the industry. Visit us at Booth 33 and connect with […]

Join Ardena at the BIO International Convention 2026, taking place June 22–25 in San Diego, California,. The BIO International Convention is one of the largest global gatherings of the biotechnology and life sciences community, bringing together leaders from biotech, pharma, investors, and service providers to explore cutting-edge science, business development, and strategic partnerships. Meet our […]

The Solubility Wall Oral bioavailability depends on two things: how much drug dissolves in the gastrointestinal tract and how much of the dissolved drug crosses the intestinal wall into the bloodstream. For BCS Class I drugs, both happen efficiently and bioavailability is high. For BCS Class II drugs, the drug dissolves poorly and absorption is […]

Fragility Is Built Into the Molecule mRNA is not a robust molecule. It was never designed to be. In a living cell, mRNA is translated quickly and then degraded, making way for new instructions. A half-life of minutes is a feature of cellular biology, not a bug. As a pharmaceutical drug substance, that biological instability […]

The Most Common Route to a Warning Letter Data integrity findings are now the single most frequently cited category in FDA warning letters to pharmaceutical manufacturers. That was not true fifteen years ago. It has become true as manufacturing has digitised, regulators have become more forensically capable, and the consequences of data manipulation have become […]

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 optimisation of a PandA-based approach delivered a robust, […]

Case study A highly promising analogue 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 […]

Nanomedicines demand tight control over particle properties, reproducibility, and scalability, yet conventional batch methods often struggle to deliver all three. In this whitepaper, Ardena’s nanomedicines experts Mark van Eldijk and Andy Bänziger explore how flow manufacturing can enable more consistent nanoparticle production, simplify scale-up, and support robust development pathways from early-stage research through GMP manufacturing. […]

The ICH has released a draft consolidated guideline (ICH Q1) that unifies the previous Q1A–Q1F series into a single global standard. This revision simplifies stability requirements, integrates lifecycle management, and expands the scope to advanced therapies and drug-device combinations. This whitepaper provides a clear overview of the key changes — from predictive tools and modeling […]

Nanomedicines are redefining pharmaceutical innovation, but their complexity demands advanced analytical solutions.In this whitepaper, Ardena explores the analytical and regulatory challenges of characterizing nanoparticle-based drug delivery systems, and how state-of-the-art techniques like AF4-MALS-DLS can provide critical insights into particle size, morphology, stability, and drug loading. Gain a deeper understanding of: – How to identify and […]