Advanced Therapy Medicinal Products (ATMPs), such as viral vectors or nucleic acids using lipid nanoparticles (LNPs) as delivery vehicle, have validated their potential for rapid development of vaccines against COVID 19, and further therapeutic applications are under investigation. Other pharmaceutically relevant nanoparticles are e.g. exosomes (extracellular vesicles), virus-like particles (VLPs), or plasmid DNA (pDNA).
Due to their size and complex structure, these nanoparticles cannot be sufficiently characterized and released for safe administration into humans by standard chromatography methods alone. Nanolytics will provide you with insights into the homogeneity and consistency of your product, and the nature of potential byproducts.
Viral Vectors (VV), Capsids
Gene therapy and vaccines use viral vectors to protect the nucleic acid administered into patients and to direct it to a target tissue. Although significant advances have been achieved for the purification of viral vectors during manufacturing by chromatography and filtration, the separation of full and empty viral particles (capsids) often remains unresolved, as well as the discrimination from capsids with undesired cargo (truncated genes, host-cell DNA, plasmid DNA). [read more]
mRNA in Lipid Nanoparticles (LNPs) and Liposomes
In-vitro mRNA manufacturing technology has enabled rapid vaccine development and supply in response to the COVID-19 pandemic. Furthermore, therapeutic applications have been under investigation since many years. For drug administration, mRNA technology requires lipid nanoparticles (LNPs) or other types of liposomes to encapsulate and protect the mRNA during delivery of the genetic information into patient cells.
mRNA quality can be assessed by standard analytical techniques (electrophoresis or chromatography), while identity needs [read more]
Exosomes (Extracellular Vesicles, EVs)
Exosomes are natural, cell-derived vesicles, playing an important part in intercellular communication of higher organisms. They transfer nucleic acids, proteins and other biological messages between cells, which makes exosomes an interesting approach for targeted drug delivery, including engineered exosomes used for encapsulation of therapeutic agents. The size of various types of EVs is extraordinarily heterogeneous with diameters ranging from approximately 40 nm up to 10 µm.
Exosomes are typically produced in low concentrations only, and purification is challenging. The product is a polydisperse mixture of active product vesicles. Extended characterization is required to qualify the process and product, to show product comparability, and allow process improvements, scale-up and validation. [read more]
Cell Therapy, Virus-Like Particles (VLPs), Plasmid DNA (pDNA), etc.
Modern medical and pharmaceutical research is developing a wide range of increasingly complex therapeutic agents and drugs and drug delivery vehicles. Alike viral vectors, LNPs, and exosomes, many of them have nanoparticular properties. Due to their size, complex structure, or even polydispersity, these entities cannot be sufficiently characterized and released for safe administration into humans by standard chromatography methods alone. [read more]