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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 tumour 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) modelling. After the first dose […]

The Guideline That Harmonised Global Bioanalysis Before ICH M10, bioanalytical method validation was governed by separate guidance documents from the FDA and EMA that, while broadly aligned, differed in specific requirements for acceptance criteria, validation parameters, and reporting expectations. A study submitted to both agencies might require two slightly different validation packages, creating additional work […]

Why Nanoparticle Fill-Finish Is Different Aseptic fill-finish for a conventional small molecule injectable involves filling a solution into vials under Grade A conditions and sealing them. The process is technically demanding from a contamination control perspective, but the drug product itself is chemically robust enough to withstand the shear forces, surface contacts, and process-related stresses […]

Beyond the Simple Solution The simplest injectable drug product is a solution: the API is fully dissolved in a compatible aqueous vehicle, the solution is sterile filtered, and it is filled into vials or prefilled syringes. A significant proportion of the injectable pipeline, however, cannot be formulated as simple solutions. Poorly water-soluble APIs, APIs that […]

Why Biologics Need Lyophilisation Proteins, monoclonal antibodies, enzymes, and other biological molecules are inherently unstable in aqueous solution. In solution, they are subject to hydrolysis, oxidation, deamidation, aggregation, and physical denaturation, degradation pathways that can reduce potency, alter immunogenicity, and compromise the safety of the product. For biologics with an intended shelf life of two […]

The High Stakes of Sterile Manufacturing A sterile injectable drug product that is contaminated with microorganisms or particulates can cause a patient serious harm or death. There is no sterilisation step at the end of aseptic fill-finish manufacturing: the product must be sterile when it is filled and sealed, and it must remain sterile throughout […]