MyBiotech scales complex nanoparticle processes from laboratory scale to preclinical and clinical manufacturing volumes with a proven, structured approach. We define critical process parameters, protect critical quality attributes (CQAs), and translate development work into robust, reproducible production. Nanomedicine scale-up from pilot and preclinical batches to GMP-ready tech transfer, we help reduce risk and shorten timelines on the path to clinic. Nanomedicine Scale-Up & Process Development Capabilities Our nanomedicine scale-up services enable a smooth transition from concept to clinic, including: - Lab-to-clinic scale-up strategy and process definition - Identification of CPPs and linkage to CQAs - Robust in-process controls and batch-to-batch consistency - Material and process comparability support - GMP-aligned documentation for transfer readiness What You Receive: - Scale-up strategy and phase-appropriate development plan - CQA/CPP linkage and control strategy summary - Manufacturing instructions - IPC plan and sampling strategy - Process risk assessment and mitigation actions - Batch records for pilot and preclinical batches - Data package for comparability (process + analytical) - Tech transfer package for GMP readiness and execution Our Scale-Up Framework (Lab → Pilot → Preclinical → GMP-ready) 1) Define the target product profile (TPP) and CQAs We align on the intended route of administration and clinical objectives, then translate them into measurable CQAs (e.g., particle size/PDI, potency, loading, release, sterility assurance strategy, stability). 2) Map CPPs and establish a design space We identify the process parameters that control CQAs and use structured experiments to define robust operating ranges. 3) Build in-process controls We implement IPCs that can be carried forward into GMP—supporting batch-to-batch consistency and meaningful trending. 4) Engineer a transferable process and control strategy We consolidate critical know-how into a tech-transfer package that supports GMP execution, risk management, and documentation readiness. 5) Demonstrate comparability across scale We generate data that supports material/process comparability and reduces risk when moving from development batches to clinical supply.
