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.
