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.
We enable phase-appropriate nanoparticle scale-up to deliver the volumes and documentation needed for IND/IMPD programs—without compromising performance.
Production of well-characterized preclinical batches to support IND/IMPD-enabling studies, including tox and efficacy packages where required.
Process optimisation and structured tech transfer into full GMP manufacturing environments—supported by GMP-aligned documentation, risk assessments, and control strategies.
We bridge early development and GMP production, ensuring quality and manufacturability at every stage starting with clinical manufacturing scale-up
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
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
For IND/IMPD-enabling studies, we manufacture well-characterized preclinical batches with GMP-representative CQAs—supporting tox, efficacy, and formulation-performance packages where required. We focus on reproducibility, documentation discipline, and analytics that translate into clinical-stage expectations.
We manufacture preclinical nanoparticle batches that are designed to be predictive for clinical manufacturing. Using scalable, controlled processes and a CQA-driven approach, we produce reproducible batches suitable for efficacy and tox studies, stability testing, and reference material generation. Each campaign is supported by defined raw-material requirements, documented processing parameters, in-process controls.
We leverage scalable production concepts—including microreactor-based approaches—to improve control over critical process conditions and reduce batch-to-batch variability. The goal is straightforward: repeatable particle formation, tight distributions, and transferable processes that remain stable as volumes increase.
To ensure preclinical batches are truly representative and de-risk the transition toward GMP, we perform comprehensive, fit-for-purpose characterisation using orthogonal analytical methods. All results are compiled into a structured data package with clear method descriptions, acceptance criteria where applicable, and trending across batches—supporting comparability, tech transfer, and later CMC/IMPD inputs.
We provide hands-on CMC support to help you move from development data to a regulatory-ready story. This includes building a phase-appropriate CMC strategy, defining CQAs and a control strategy, and preparing structured inputs for IND/IMPD packages. We also support risk-based documentation (e.g., QRM/FMEA), justification of materials and critical process parameters, and alignment of analytical methods and stability-indicating assays with clinical-stage expectations
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.
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