Expert Insights

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Multiple possibilities, one decision Pediatric formulation development usually starts with understanding the exact drug product (DP) requirements followed by subsequent benchmarking against the available formulation options as there is no such thing as one technology fits all. Before starting, the above evaluation sets the taste masking, the stability profile, the final presentation, and the age […]

LNP manufacturing has become one of the fastest-growing areas in modern pharmaceutical development. Lipid nanoparticles (LNPs) have moved from a niche formulation approach to one of the most validated platforms for delivering complex therapeutic payloads, and demand for specialised development and manufacturing partners has grown alongside them. According to market research firm InsightAce Analytic, the […]

HPAPI contract manufacturing companies are not interchangeable, and choosing the right one is among the highest-stakes decisions in a potent-compound programme.  Pick the wrong partner and it surfaces later: as a containment finding, a failed cleaning validation, or a technology transfer that stalls before your first batch.  This guide is about how to make that […]

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

Delumping is an established operation in pharmaceutical manufacturing, used to produce more homogeneous, free-flowing powders across drug substance and drug product processes. When agglomeration is left unaddressed, it can affect powder flow, charging, homogeneity, downstream processing, cycle time and yield. In this technical paper, Kim Geurts, Scientist PR&D and Manufacturing, Enabling Chemistry, explains how Ardena […]

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 […]

What does it take to move innovative science from the lab toward the patient? In this episode of We Know Development™, Mark van Eldijk, Vice President of Science and Technology at Ardena, discusses nanoparticles, advanced drug development, and the challenges of translating complex technologies into medicines that can make a real impact. Discover the science, […]

Welcome to We Know Development™, a podcast from Ardena about the people, decisions, and expertise behind drug development. Drug development is often described through science, technology, quality, and regulation. All of those are essential. But behind every successful program are people making decisions, navigating uncertainty, solving complex challenges, and building trust. In We Know Development, […]