Why Standard Module 3 Templates Fall Short for Nanomedicines The Common Technical Document (CTD) Module 3 template was designed for conventional small molecule and biological drug products. For nanomedicine products, including lipid nanoparticles, polymeric nanoparticles, and metal oxide nanoparticle systems, the template provides a useful framework but cannot accommodate the full complexity of the characterisation […]

Not Every Solubility Problem Needs a Complex Solution When a development team encounters a BCS Class II molecule with poor aqueous solubility, the instinct is often to reach for the most technically sophisticated tool available: an amorphous solid dispersion by hot melt extrusion or spray drying, or a lipid-based formulation system. These technologies are powerful, […]

The Case for Sustained Release at the Nanoscale Many therapeutic molecules have pharmacokinetic profiles that are poorly suited to their intended use. A drug that clears from circulation within a few hours may need to be dosed multiple times daily to maintain therapeutic concentrations, creating peaks and troughs in exposure that lead to toxicity at […]

A Rapidly Maturing Regulatory Framework The approval of the first mRNA COVID-19 vaccines in late 2020 was a watershed moment for LNP-based medicines and for the regulatory agencies that oversee them. Within the space of two years, both the FDA and EMA moved from limited experience with LNP products to reviewing and approving the most […]

Inorganic Nanoparticles in Pharmaceutical Development The pharmaceutical nanoparticle landscape extends well beyond lipid and polymer systems. Metal and metal oxide nanoparticles, particularly gold nanoparticles and iron oxide nanoparticles, have physical properties that make them uniquely useful in diagnostic imaging, thermal therapy, and the emerging field of theranostics, where a single agent combines diagnostic and therapeutic […]

The Problem That Most mRNA Gets Wrong The appeal of mRNA therapeutics is straightforward: deliver the genetic instructions for a beneficial protein directly into cells, let the cell’s own machinery produce the protein, and achieve a therapeutic effect without permanently altering the genome. The challenge is equally clear: mRNA is a large, negatively charged, inherently […]

Why CQAs Matter More for LNPs Than for Conventional Drug Products For a conventional small molecule tablet, the critical quality attributes that determine in vivo performance, dissolution rate, disintegration time, content uniformity, are relatively straightforward to measure and control. For a lipid nanoparticle (LNP) system, the relationship between physicochemical properties and in vivo behaviour is […]

The Complexity Behind the Acronym Antibody-drug conjugates (ADCs) are a class of targeted oncology therapeutics that combine the selectivity of a monoclonal antibody with the potency of a cytotoxic small molecule payload. The concept is elegant: deliver a chemotherapy agent directly to the tumour cell, spare normal tissue, and improve the therapeutic index over conventional […]

The Site Built for Difficult Molecules Not every pharmaceutical development programme involves a straightforward API in a standard formulation. Some molecules are highly cytotoxic. Some are scheduled narcotics. Some are biologically active at doses measured in micrograms. These are not unusual compounds at the edges of drug development. They are increasingly common in oncology, neurology, […]

Where the Clinical Trial Meets the Laboratory Ardena’s Assen facility sits at the intersection of two things that are normally separated: the bioanalytical laboratory that measures what is happening in patients and the clinical supply operation that gets the drug to them. Bringing these capabilities together under one roof is not just operationally convenient. It […]

A Site Built Around Nanoparticles Ardena’s facility in Oss, the Netherlands, is not a general pharmaceutical site that also does nanomedicines. It is a site designed from the ground up for nanoparticle development and manufacturing. The equipment, the analytical infrastructure, the technical expertise, and the quality systems are all configured around the specific demands of […]

Same Data, Two Submissions If your clinical programme runs trials in both the European Union and the United States, you will submit essentially the same scientific data to two different regulatory agencies in two different formats with two different sets of expectations. The Investigational Medicinal Product Dossier (IMPD) goes to the relevant national competent authority […]