We know development. Here is what our scientists think about it.
Same Data, Two Submissions If your clinical program 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 […]
The Site That Does the Most Of all Ardena’s European sites, Ghent carries the broadest scope. It is where solid state research happens. It is where oral solid development and manufacturing runs. It is also where sterile injectables, lyophilized products, and complex parenteral formulations are developed and manufactured under GMP. For a program that spans […]
Beyond the Batch Paradigm Pharmaceutical tablet manufacturing has been batch-based for most of its history. Raw materials in, process step by step, finished product out, test and release. The batch is a defined, auditable unit of production with a clear beginning and end. Continuous manufacturing challenges that model. Materials flow through an integrated process train […]
The Problem with Testing at the End Traditional pharmaceutical manufacturing is built around the idea of testing finished product. You make a batch, you sample it, you test it, and you decide whether it passes. The problem is that by the time you know a batch is out of specification, you have already used the […]
The Double Problem The molecules that generate the most clinical excitement are often the ones that cause the most formulation headaches. Modern oncology APIs, for example, tend to be both highly potent (small doses, strict containment requirements) and poorly soluble (BCS Class II or IV, significant bioavailability challenges). Solving one problem in isolation is hard […]
The Question Nobody Asks Early Enough When you are developing a nanoparticle drug product, the bioanalytical question you need to answer is not simply ‘how much drug is in the blood?’ It is ‘which form of the drug are you measuring, and what does that tell you about what is actually happening in the patient?’ […]
A Different Kind of Drug CAR-T cell therapies are not small molecules. They are not even biologics in the conventional sense. They are living, replicating therapeutic agents: a patient’s own T cells, extracted, genetically modified to express a chimeric antigen receptor, expanded ex vivo, and reinfused to hunt and destroy tumor cells. That extraordinary mechanism […]
A Platform Proven at Unprecedented Scale The COVID-19 pandemic accelerated the clinical and regulatory validation of mRNA LNP technology at a pace that would otherwise have taken a decade. Within two years of the initial sequencing of the SARS-CoV-2 spike protein, billions of doses of mRNA vaccine had been manufactured, distributed globally, administered under emergency […]
Two Mature Platforms, Two Different Profiles Lipid nanoparticles and biodegradable polymeric nanoparticles are both well-established pharmaceutical delivery platforms with approved products and substantial clinical track records. LNPs are the platform behind the COVID-19 mRNA vaccines, liposomal doxorubicin, and a growing range of nucleic acid therapeutics. Polymeric nanoparticles, particularly those based on PLGA and PLA, have […]
The Scale-Up Challenge Specific to LNPs Scale-up is a challenge in pharmaceutical manufacturing generally, but it is a particularly acute challenge for lipid nanoparticle products. For a conventional tablet, scaling from a 1 kilogram development batch to a 100 kilogram GMP batch involves larger equipment with similar operating principles, and the scale-up relationships, though not […]
Why Spray Drying Has a Thirty-Year Track Record in Pharma Spray drying is not a new technology. It has been used in the food industry for over a century and in pharmaceutical manufacturing since the 1980s. What makes it particularly relevant to modern drug development is the growth of the BCS Class II molecule pipeline: […]
The Role of PK Data in Early Clinical Development Pharmacokinetic data is the foundation on which dose selection decisions are built in early clinical development. Before the first human dose is administered, the preclinical PK profile provides predictions of human exposure based on allometric scaling or physiologically based pharmacokinetic (PBPK) modeling. After the first dose […]
