Blog

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 […]

In the fast-paced world of early-phase drug development, successful formulation development is often the bridge between a promising molecule and a viable clinical candidate.  During BIO 2026 in San Diego, Henny Zijlstra, Chief Commercial Officer at Ardena, sat down with BioPharma Boardroom to discuss how integrated CDMO strategies are shaping the future of early-phase pipelines.  […]

Measuring the size of nanomaterials is a critical step in developing safe and effective drug products in modern nanomedicine. Dynamic light scattering (DLS) is the most commonly used technique for this purpose in pharmaceutical industry due to its simplicity.  It has, however, low resolution (if the product contains two size populations, such as 50 and […]

The modern pharmaceutical pipeline is rich in highly potent, highly specific New Chemical Entities (NCEs). Yet, approximately 70% to 90% of new chemical entities and up to 40% of marketed drugs fall within BCS Class II or IV, reflecting the widespread challenge of poor aqueous solubility.  When a molecule crosses your desk as a “brick […]

As molecular complexity continues to increase, pharmaceutical companies are increasingly turning to AI in drug development to predict and optimize critical properties such as solubility and bioavailability. By identifying patterns in chemical data, AI can estimate parameters such as pKa and logP, as well as predict formulation-dependent effects on absorption.  These capabilities allow for more […]

In the complex world of nanomedicine, staying ahead of analytical challenges is a core focus of our work at Ardena. We are looking forward to taking this conversation further at our upcoming ‘Nanomedicine & Bioconjugation Symposium 2026’ this September. As an organization, our guiding principle is “We Know Nano™,” reflecting our deep-rooted expertise in navigating […]

In a recent industry roundtable hosted by 24/7 Biopharma, a panel of leaders examined how rising molecular complexity and shifting market dynamics are reshaping the drug development landscape (link to the article). Among the key takeaways, Henny Zijlstra, CCO at Ardena, highlighted that for biotech companies, success depends on partnering with an integrated CDMO to […]

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 […]

Why Scale-Up Surprises Happen The development laboratory is a controlled, forgiving environment. The scientist is present at every step, making small adjustments and observations that never make it into the batch record. The equipment is flexible. The batch size is small enough that a failed experiment costs almost nothing. GMP manufacturing is the opposite. The […]

Natural Nanoparticles with Pharmaceutical Potential Every cell in the human body releases extracellular vesicles (EVs). These membrane-bound particles, ranging from roughly 30 nanometres to several micrometres in size, carry proteins, lipids, nucleic acids, and metabolites between cells. They are natural intercellular communication vehicles, evolved to transfer biological cargo across biological barriers. The pharmaceutical interest in […]