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Drug Substance

Scale-up Process Development

Over 1,000x scale-up with stage-by-stage analytics, validation and documentation

From Lab to Large-Scale Production

Properties held constant from the first lab batch to pilot scale.

03/

Nanoparticles do not scale like conventional drugs: size, stability and release behavior can shift with every change in batch size. OmniParticles builds process development around that reality, refining formulation parameters, material selection and workflows and verifying each step with in-house analytics, so your formulation moves from early research to non-clinical and clinical manufacturing without losing what made it work.

Stainless steel reactor for nanoparticle scale-up

Photos of equipment at OmniParticles

Scale-up process development with analytics at every stage

What we offer

1

Scale-up development

Over 1,000x scale-up from early-stage research to non-clinical and clinical manufacturing, preserving size uniformity, physicochemical properties and efficacy.

2

Characterization & composition analysis

DLS for hydrodynamic diameter, PDI and aggregation; TEM for size distribution, grain size and morphology with representative images; UV-Vis extinction spectra and zeta-potential for surface charge and colloidal stability; ICP-MS elemental composition of organic and inorganic samples down to parts per trillion, LC-MS and GPC for molecular weight, and HPLC (including SEC mode, triple detector).

3

Analytical method development

Customized methods for each stage, from rapid on-site size and morphology checks to ion quantification and stability testing.

4

Process validation & documentation

Reproducibility aligned with FDA and EMA expectations, backed by process development reports and tech transfer dossiers.

Transmission electron microscope for nanoparticle analysis

Ready to scale up?

Talk to us about moving your formulation from lab to pilot scale.

CONTACT US

TEL

+82 2-741-6110

E-mail

Head Office

2F, 20 Seongsui-ro 7-gil, Seongdong-gu, Seoul, Korea

DP Facility

3F, 20 Seongsui-ro 7-gil, Seongdong-gu, Seoul, Korea

DS Facility

4F, 20 Seongsui-ro 7-gil, Seongdong-gu, Seoul, Korea

© Copyright 2026 OmniParticles. All Rights Reserved.

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