We support nanoparticle drug products and nanotechnology enabled drug products across platforms such as lipid nanoparticles (LNPs), polymer nanoparticles, liposomes, nanoemulsions, micelles, and other complex particulate systems—designed for oral, injectable, and topical applications. As your program advances, we translate development work into reproducible, compliant production—covering all CMC services, technical transfer, scale-up, process definition, and GMP-aligned documentation.
Our capabilities extend to aseptic processing, sterile filtration, aseptic fill & finish, and lyophilization where required, supported by finished product testing and stability studies to demonstrate ongoing control and long-term performance. Whether you need a feasibility batch, a pilot run, or clinical trial material (CTM), we tailor the package to your timeline and regulatory pathway—helping you reduce risk, accelerate decisions, and move confidently from concept to released drug product.
We develop and optimize nanoparticle drug products with scalability in mind from day one. Using phase-appropriate experiments and analytics, we define critical quality attributes (CQAs), de-risk excipients and process parameters, and build a development package that supports progression to preclinical and clinical manufacturing.
Nanoformulation CDMO services includes scaling complex nanoparticle processes from lab scale to preclinical and clinical volumes while preserving key product attributes. Through process definition, control strategy development and structured technical transfer, we enable robust manufacturing performance and reliable batch-to-batch consistency.
Our nanomedicine CMC services deliver compliant manufacturing solutions for nanomedicines and nanoparticle-based drug products. We translate your process into a GMP-ready workflow—including documentation, in-process controls and quality systems—supporting phase-appropriate GMP supply for clinical development and beyond.
We provide aseptic processing for sterile drug products, including sterile filtration, aseptic filling, lyophilisation and container-closure implementation. For liquid or freeze-dried presentations, we align process definition and primary packaging selection to ensure a clinically usable, scalable and compliant final drug products.
MyBiotech delivers phase-appropriate QC testing and stability programs within finished drug product testing to ensure ongoing control and long-term performance of nanoformulations. By focusing on CQAs, clear specifications and data trending, we support release, comparability and regulatory readiness.
We provide end-to-end regulatory support including nanoparticle CMC seervices, technical documentation and preparation of IND/IMPD CMC sections. Our team aligns development decisions with your target pathway to reduce risk, strengthen submission packages and keep programs moving efficiently.
LNPs, liposomes, polymer nanoparticles, inorganic nanoparticles
Nanoemulsions, micelles, complex particulate systems
Development & scale-up
Formulation and process development
Lab-to-clinic scale-up and tech transfer
GMP-aligned documentation and control strategy
Manufacturing & quality
EU GMP manufacturing and clinical supply
Aseptic processing, sterile filtration, fill & finish
Lyophilization (freeze-drying), QC testing and ICH stability
Stay informed, connect with our experts, and discover how MyBiotech advances nanomedicine through trusted technologies and GMP manufacturing solutions.
