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1st lab scale
2nd lab scale
1st pilot scale
2nd pilot scale
Image by Freepik, Flaticon
Seamless Transition from Lab to Large-Scale Production
OmniParticles provides end-to-end support for transitioning nanomedicine formulations from research to commercial production, maintaining stability, uniformity, and efficacy.
What We Offer
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Scale-up Development
Comprehensive scale-up services ensure efficient transition from early-stage research to non-clinical and clinical manufacturing. Process optimization maintains over 1,000x scale-up while preserving size uniformity, physicochemical properties, and efficacy. Stepwise manufacturability assessments ensure commercial viability and regulatory compliance.
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Analytical Method Development
Customized analytical methods are developed to support each stage of nanomedicine production. Services include rapid on-site characterization of nanoparticle size, morphology, and colloidal stability, as well as ion quantification (ICP-MS), chromatographic qualification (LC-MS, GPC), and stability testing.
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Process Validation & Documentation
Process validation ensures reproducibility and regulatory alignment with major health authorities such as FDA and EMA. Comprehensive documentation, including process development reports and tech transfer dossiers, facilitates efficient knowledge transfer and regulatory compliance.
Nanomedicine
Process development
for Productivity
The transformation of nanoparticles into nanomedicines remains a challenging and time-intensive process. Despite decades of research advancements, clinical application has been slow, with most approved nanomedicines having highly specific and narrow use cases. Even with recent breakthroughs—such as mRNA-based COVID-19 vaccines—progress in nanomedicine remains limited to select applications, highlighting the need for more efficient development strategies.
At OmniParticles, we bridge this gap by focusing on tailored process development strategies for nanomedicine. Unlike conventional drug modalities, nanoparticles require specialized formulation approaches that optimize stability, bioavailability, and controlled drug release. Our expertise extends beyond standard methodologies, allowing us to refine formulation parameters, material selection, and process workflows to enhance scalability and real-world applicability.
By leveraging our deep understanding of nanoparticle behavior, we help overcome common manufacturing bottlenecks in nanomedicine development. Our systematic approach ensures that novel formulations transition seamlessly from early-stage research to practical, large-scale applications.
OmniParticles