Nanomedicine
Process Development
for Productivity ​
Despite its excellent novelty, the development of
nanoparticles into nanomedicine encounters delays
primarily due to the intricate and time-consuming
nature of the process. While nanoparticles have
demonstrated significant achievements in research
over the past decades, their application has been slow,
especially in the realm of nanomedicine. Only recently
have new approaches for nanomedicine development
begun to emerge (e.g. COVID-19), yet they remain
limited in specific areas, while all approved
nanomedicines also exhibit narrow scopes of application.​
​
Our expertise lies in the development of analysis
methods tailored specifically for nanomedicine.
Setting us apart from conventional modalities such as
small molecules and biologics, we possess extensive
experience in physicochemical analysis of nano-sized
drugs, enabling us to meet regulatory recommendations
from authorities such as the FDA and EMA with precision
and confidence. In addition to fundamental analysis of
physical properties, we excel in drug-specific analysis
and advanced bioanalytical development through
in-vitro and in-vivo experiments, crucial for comprehensive
drug development. Our team of subject matter experts
offers invaluable insights into drug analysis,
ensuring a thorough understanding of each
compound's behavior and efficacy.​
Capabilities of process development
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Nano-analytical development​
On site analysis; fast and precise, size and morphology, colloidal
stability,quantification of ions (ICP-MS), qualification by
chromatography(LC-MS and GPC), and more​
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Scale-up development​
Over 1,000x scale up (lab-to-commercial) of therapeutic nanoparticles,
maintaining size uniformity, physicochemical properties,
and drug suitability.
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Drug suitability​
Stability test; stress, acceleration test, elemental impurities, and more