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 […]

The Problem with Both Mistakes Under-supply stops a clinical trial. Patients cannot be dosed, sites go on hold, and the timeline slips in ways that are expensive and sometimes impossible to recover. The consequences are obvious and everyone works hard to avoid them. Over-manufacturing is less dramatic but equally costly. A 10 kilogram GMP batch […]

Two Goals That Sound the Same but Are Not Topical and transdermal are often used interchangeably. They should not be. A topical formulation delivers drug to the skin or the tissue beneath it. The goal is local effect: treat a skin condition, reduce inflammation in a joint just below the surface, or act on target […]

The Appeal Is Real. So Are the Traps. Drug repurposing, taking a compound with an established safety profile and investigating it for a new indication, offers a genuinely shorter path to the clinic. You start with human safety data. You may have existing PK characterisation. You understand the compound’s behaviour in ways that a completely […]

Why the Lung Is Worth the Complexity The lungs offer a drug delivery surface area of roughly 70 to 100 square metres, a thin alveolar membrane, rich vasculature, and, for respiratory conditions, direct access to the target tissue. For drugs targeting the lung, inhalation delivers drug precisely where it is needed, at doses a fraction […]

Excipients Are Not Passive The word inactive ingredient implies that excipients do nothing. That is a convenient regulatory classification, not a pharmacological reality. Excipients interact with APIs chemically. They compete for water. They affect the pH microenvironment within a tablet. They adsorb onto drug particles and change their surface properties. They can accelerate degradation pathways, […]

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 […]