At CD Bioparticles, our nanoparticle scalability testing service is dedicated to translating laboratory scale breakthroughs in nanomaterials into industrial reality. We have addressed the critical gap between small-scale synthesis (milligrams to grams) and large-scale manufacturing (kilograms to tons), a challenge where 70% of promising nanoparticle projects fail due to unforeseen scalability issues. Our interdisciplinary team of materials scientists, chemical engineers, and regulatory experts provides end-to-end testing solutions to ensure that your nanoparticles maintain performance, consistency, and cost-effectiveness across the entire production scale. Whether you are developing drug delivery systems, catalytic materials, or electronic nanocomposites, we will tailor our methods based on your unique material properties and commercial goals.
Figure 1. Nanoparticle Scalability Testing Service.
What is Nanoparticle Scalability?
Nanoparticle scalability refers to the ability to increase the production of nanoparticles from laboratory bench quantities to industrial scales while maintaining their critical properties at all times. These attributes include:
Size and size distribution are crucial for performance, especially in optics, drug delivery, and catalysis.
- Shape and morphology: can affect surface area, reactivity, and biological interactions.
- Surface chemistry: ligand coverage, charge, and functionalization must be consistent.
- Purity: Minimizing contaminants is crucial, especially in biomedical applications.
- Output: Maximize the available product quantity of raw materials.
- Reproducibility between batches: Ensure that each batch of products produced meets the same quality standards.
- Stability: Maintain the integrity of particles during larger scale storage and processing.
Why is Scalability Testing Crucial?
Neglecting scalability in the early stages of the development process may lead to significant delays and cost overruns. Scalability testing helps to:
Identify bottlenecks: Identify steps in the synthesis or purification process that are difficult to scale up or costly.
Optimize the process: Fine tune the reaction conditions, mixing scheme, and purification steps to obtain a larger volume.
Reduce costs: Discover more cost-effective raw materials or production methods with lower energy consumption.
Ensure product quality: Verify whether large-scale production produces nanoparticles with consistent and required performance.
Accelerate time to market: Simplify the transition from research and development to manufacturing.
Go venture capital: Provide data to investors and stakeholders to prove that products can be economically manufactured.
Our Services
- Scalability assessment and gap analysis
Laboratory scale benchmark testing: Using advanced tools (TEM, DLS, XPS) to rigorously characterize the synthesized nanoparticles in the laboratory, in order to establish baseline indicators - size distribution, surface charge, functional activity, and purity.
Expand feasibility study: Evaluate production parameters (reaction kinetics, equipment compatibility, raw material sources) to identify potential bottlenecks (such as heat transfer limitations or agglomeration risks in large reactors).
Gap report: Conduct a detailed analysis of the performance of laboratory scale and industrial requirements, highlighting key areas that need optimization (such as yield loss, batch changes, or cost overruns).
- Process optimization and validation
Parameter screening: Using experimental design (DoE), we systematically tested variables (temperature, stirring rate, reagent concentration) on a pilot scale to determine robust conditions for maintaining nanoparticle quality.
Equipment adaptation: scaling expertise from laboratory tools (round bottom flasks, ultrasonic instruments) to industrial systems (continuous flow reactors, high shear mixers), as well as protocol adjustments for simulating laboratory conditions.
Increasing production and cost: Strategies that improve production efficiency while maintaining functionality (such as reducing purification steps and replacing high cost reagents) typically reduce the cost of scaling up by 20-35%.
- Comprehensive production verification
Pilot to industrial scale testing: Production is carried out using industrial equipment on a scale of 10-100kg to verify the consistency of each batch.
Long term stability testing: Evaluate the shelf life and performance retention of nanoparticles under industrial storage conditions such as temperature fluctuations and packaging materials.
Final expansion roadmap: gradually transitioning to a comprehensive manufacturing plan, including equipment specifications, operator training guidelines, and ongoing quality monitoring protocols.
Our Advantages
- Professional Knowledge to Provide Results
Our team has an average of over 15 years of experience in nanomaterial scaling up, supporting over 100 projects ranging from academic spin offs to Fortune 500 companies. We have successfully scaled various nanoparticles, including lipid nanoparticles (LNPs) for mRNA vaccines, platinum catalysts for fuel cells, and quantum dots for display technology.
- Advanced Technology and Methods
Computational modeling: CFD simulation and machine learning algorithms can predict amplification behavior, reducing the need for expensive trial and error.
High throughput screening: The automated platform analyzes over 1000 samples daily to assess the variability of batch processing and ensure data-driven decision-making.
We recognize that scalability challenges vary by nanoparticle type: mesoporous silica nanoparticles require different optimizations than protein conjugated gold nanoparticles. Our approach is customized based on the chemical properties, functions, and target applications of your materials, ensuring that the solution works in your specific industrial environment.
Workflow
Synthesis and Optimization
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| Initial Consultation | We collaborate with your team to define goals (production volume, timeline, regulatory targets) and critical quality attributes (CQAs) for your nanoparticles. |
| Lab-Scale Profiling | Comprehensive characterization of your lab samples to establish performance benchmarks and identify potential scale-up risks. |
| Pilot-Scale Testing | Production at 1–10 kg scales using scaled-down industrial equipment, with systematic parameter optimization. |
| Data Analysis & Optimization | Comparative analysis of pilot vs. lab data, with adjustments to processes (e.g., mixing protocols, drying methods) to resolve discrepancies. |
| Delivery & Support | Final report with optimized protocols, scale-up roadmap, and ongoing consultation during industrial implementation. |
Summary
Nanoparticle scalability testing is a key component of the nanotechnology development pipeline, ensuring that innovative materials and technologies can be mass-produced while maintaining their performance and safety. By utilizing advanced testing methods and best practices, researchers and manufacturers can overcome the challenges of expanding production and successfully bring products to market. With the continuous development of nanotechnology, the importance of scalability testing will only increase, driving innovation and enabling nanotechnology to be widely adopted in various industries.
