NanoComposix produces GMP/ISO13485 compliant nanoparticles for medical devices, topical therapeutics and combination products (drug/device) for Phase I and Phase II clinical trials. In collaboration with our San Diego based partners, we can provide a complete solution of particle fabrication, formulation and sterile fill. Whether you are looking for materials for proof of concept clinical trials or scaling towards production we will work with you to develop a process that is both cost-effective and compliant.

One of the challenges of GMP nanoparticle production is defining the appropriate level of controls and processes that are necessary in order to manage risk. For each customer, we collaboratively work through a multi-stage process to define a GMP transition plan that is appropriate for the target application. At the end of each stage a design review meeting is conducted to review work completed and to plan the next stage. A typical development process is provided below.

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Phase 0: Project Scope and Preliminary Proposal

Determine the scope of the project and a produce a preliminary development plan that defines all steps in the project and associated milestones. An assessment of the current state of the technology will be made to determine if the process is ready for transfer to manufacturing or if there more research that needs to be performed.

Phase 1: Product Definition

Capture design inputs, customer requirements and initial product specifications. Conduct a preliminary hazard identification and risk analysis. Complete a product development checklist to determine which steps of the product development process are required for your project. The completed checklist becomes the outline for your design and development plan.

Phase 2: Product Specification

Draft the Product Specification which includes a detailed description of all requirements for your product (project background, scope, intended use, product overview, product requirements, design characteristics, physical properties, storage and stability, packaging, shipping, labeling, manufacturing, reproducibility, product training, regulatory, safety, documentation, and intellectual property). Formalize risk management and produce a Failure Mode Effects Analysis (FMEA) which is a step-by-step approach for identifying all possible failures in the process. Produce a verification test plan that describes how all of the product specifications will be tested and verified.

Phase 3: Detailed Design

Fabrication of prototype lots using draft manufacturing instructions, methods and batch records. Identify any additional test methods that need to be developed and validated. Define material specifications, a draft bill of materials, packaging specifications, and labeling specifications. Qualify suppliers and release Product Specification.

Phase 4: Design Verification

Draft Manufacturing Master Record (complete set of instruction on how to make your product: material specifications, receiving inspections, bill of materials, receiving inspection, manufacturing methods, process instruction, manufacturing equipment, environmental controls, test methods and equipment, final inspection instructions, calibration methods, labels and packaging, shipping, and storage). Perform pre-production manufacturing (engineering runs). Begin stability testing. Perform packaging, labeling and shipping tests.

Phase 5: Product Design Validation

Release all manufacturing instructions, methods and batch records in the Manufacturing Master Record. Validate manufacturing process (produce and test three batches to ensure that all batches meet the Product Specification). Produce stability, packaging and shipping test reports. Finalize safety data sheets and certificates of analysis.

Phase 6: Design Transfer

Finalize design history file and do product release to manufacturing. Close design review and provide documentation transfer to client.

Case Studies

Study #1: R&D of Nanoparticles as a Component of a Medical Device

R&D Product Development

NanoComposix was contracted to develop an ultra-bright reporter particle for a diagnostic company that is commercializing a fluorescent-based lateral flow device. During the R&D stage, test reports were produced and cataloged in the design history file. A product specification was finalized and an FEMA conducted. Manufacturing methods for each of the steps were drafted and batch records were produced for prototype runs. Raw material suppliers were qualified and materials were received under the QMS. Design review meetings were held to review the specifications, manufacturing and test methods, and perform hazard analysis. Engineering runs were performed and released batches delivered to the customer. At the end of the project, all manufacturing methods and the complete device history file was transferred to the customer.

Study #2: University Technology Transfer

R&D Scale-up Product Development

NanoComposix was contracted to assist in the transfer an immune-stimulant nanoparticle synthesis developed in a university lab to cGMP manufacturing. A technology transfer was performed where NanoComposix observed and meticulously recorded every detail of the synthesis at the university. Equipment and reagents were exactly duplicated for a repeat synthesis at nanoComposix. A preliminary sensitivity analysis was performed to determine the variables that affected the critical parameters of the synthesis. Draft manufacturing methods were produced at the small scale and additional information recorded at critical steps. Scaling was investigated at 5×, 20×, and 100× using new fabrication and processing methods. The scaled solutions were measured using validated test methods. Released batches were provided for safety and pre-clinical studies.

Study #3: Second Supplier for R&D Manufacturing

R&D Product Development Commercial Supply

A customer required a second source for a topical therapeutic with a nanoparticle component. A Manufacturing Master Record was provided to nanoComposix and the synthesis was repeated in-house. A Quality Plan was developed, MMR documents were transferred and adapted into our QMS, and engineering runs were performed. Additional test methods were developed and validated. New suppliers were qualified. A cGMP compliant qualification batch was produced and the material delivered to the customer. NanoComposix was approved as a second source by the customer.

Study #4: Scaled Manufacturing

Commercial Supply

A photothermal nanoparticle for acne treatment was co-developed with NanoComposix and Sienna Labs. A Product Specification was released and a complete Manufacturing Master Record was produced. Raw materials were received under the QMS from qualified suppliers. Validation batches were manufactured. NanoComposix passed a supplier ISO 13485 audit from the customer with no findings. Clinical supply material is now produced on-demand for the customer.

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