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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.​

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Capabilities of process development

  • 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​
     

  • Scale-up development​
    Over 1,000x scale up (lab-to-commercial) of therapeutic nanoparticles,
    maintaining size uniformity, physicochemical properties,
    and drug suitability.

     

  • Drug suitability​
    Stability test; stress, acceleration test, elemental impurities, and more

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