Biomay Offers Lipid-Nanoparticle Formulation Services for RNA Pharmaceuticals
Biomay today announced to offer GMP
services for lipid-based nanoparticles (LNPs). With this, the company
has completed its end-to-end platform for manufacturing of GMP-grade
mRNA drugs from scratch. A comprehensive list of LNP-specific and
GMP-conform analytical assays support that service offering.
Those services are comprised in Biomay’s LNP platform:
- GMP manufacturing of LNP-formulated mRNA
- Process development (e.g. integration of custom-specific lipids)
- Development of analytical assays for LNPs
- Aseptic filling of LNPs for clinical or research use
- Analytical characterization and release testing of LNPs
Lipid-based nanoparticles are complex and spherical structures of sub-microscopic size (typically smaller than 100 nm – therefore „nano“). The characteristic LNP structure protects the RNA active ingredient from degradation, facilitates its cellular uptake and provides higher efficacy to the drug or the vaccine. LNPs are composed of a set of different types of lipids, some of which are rather generic (such as cholesterol). Other lipid compounds are highly project- or client-specific (such as ionizable lipids). Biomay’s LNP platform is flexible in order to incorporate any customized lipids into the particle.
Biomay has in-house in place a powerful set of LNP-specific analytical assays to perform GMP-conform quality control, including for instance:
- Dynamic light scattering / DLS to determine LNP size and polydispersity
- Fluorometric determination of encapsulation efficiency and mRNA content
- LC/MS to determine identity and content of the lipids
- Capillary electrophoresis for mRNA integrity
- Rapid sterility testing
With its latest LNP services, Biomay is now one of only a few CDMOs worldwide being able to offer the whole processing chain for mRNA, essentially without subcontracting. The platform begins with template DNA preparation, continues with mRNA manufacturing and LNP formulation, and ends with aseptic filling. Besides mRNA, the LNP platform can also be applied for other (non-coding) RNA formats, such as micro RNA, small-interfering RNA or guide RNA.
