End-to-end GMP services for nanomedicines—formulation, production for clinics, aseptic Fill & Finish, lyophilization, QC, stability, and batch release—backed by a phase-appropriate CMC and control strategy. We ensure robust documentation, comparability across scale, and stability-indicating analytics to support IND/IMPD timelines. For batch release and logistics, we coordinate QP-ready documentation, release testing completion, and shipment planning (to ensure on-time, compliant delivery.
MyBitoech facility includes more than 500 m² of dedicated, regulated manufacturing space equipped to support GMP nanoparticle manufacturing. We support the full nanoparticle drug product manufacturing lifecycle—from process transfer and GMP readiness assessments to production execution, in-process controls, and final documentation. Our teams work closely across Manufacturing, QC, and QA to ensure batch consistency, data integrity, and phase-appropriate release strategies.
In parallel, we help define critical process parameters and critical quality attributes to ensure your process is robust, scalable, and aligned with regulatory expectations. Depending on project needs, we manufacture engineering and demonstration batches, GMP clinical batches, and supporting stability/retain samples. Complementary capabilities such as lyophilization, controlled storage, and analytical testing allow us to deliver integrated programs under one roof—reducing interfaces and accelerating timelines from development to clinical supply.
Precision aseptic fill & finish for next-generation injectables and nanotechnology-based therapeutics
At MyBiotech, we release and certify GMP-compliant batches using strategies designed for each product category—ensuring consistency, safety, and quality from development to release.
MyBiotech provides EU-based, end-to-end GMP manufacturing for nanomedicines and nanoparticle drug products—from early clinical development through CTM manufacturing to commercial supply. We support LNPs, liposomes, polymer nanoparticles, nanoemulsions, micelles, and other complex formulations with GMP and non-GMP scale-up, tech transfer, and robust analytics. Using phase-appropriate characterization and strong process control, we ensure consistent particle quality, stability, purity, and performance. Every program follows a complete GMP framework, including process and method validation, and we certify GMP batches with product-specific release strategies.
Our scientists develop and validate analytical methods specifically for nanomedicine and nanoparticle-based drug products, covering particle size distribution, encapsulation efficiency, purity, stability and beyond for advanced quality attributes.
With expertise in complex formulations, high-potency APIs, and advanced nanocarriers, we provide a secure and compliant environment for producing clinical trial materials. Our integrated approach accelerates progress from early clinical development to commercial readiness.
We offer robust aseptic Fill & Finish capabilities for GMP-grade clinical batches, ensuring sterile, high-quality, and consistent supply across all clinical phases.
Each batch is subject to stringent QA and QC procedures, including extensive testing and documentation aligned with GMP guidelines. This ensures every CTM shipment meets predefined specifications and regulatory expectations.
We conduct ICH-compliant stability studies across multiple temperature and humidity conditions to confirm product shelf life, storage requirements, and long-term performance.
We perform full palette of release analytics and issue GMP batch certification following detailed review of analytical data, documentation, and compliance metrics.
Our logistics team coordinates the full clinical supply chain—from production and storage to compliant distribution of CTM to trial sites worldwide—with complete traceability and temperature control.
MyBiotech provides end-to-end regulatory support, including preparation of IND and IMPD CMC filings, technical documentation, and regulatory strategy guidance for global submissions.
Stay informed, connect with our experts, and discover how MyBiotech advances nanomedicine through trusted technologies and GMP manufacturing solutions.
