GMP Nanomaterial Synthesis & Manufacturing

Sienna Biopharmaceutical partnered with us to co-develop a photothermal acne treatment made of nanoparticles. The technology is made possible by highly concentrated silica coated silver nanoplates that are introduced into the hair follicles of over-productive oil glands. Standard dermatology lasers are then used to locally heat and impair the nearby sebaceous glands, reducing oil production and acne.

In order to make this therapy successful, the silver nanoplantes needed to be protected from the skin’s local environment. We worked closely with Sienna to design and optimize the silica encapsulation, maximizing the formulation’s stability on skin and thereby increasing treatment efficacy.

Transfer to GMP manufacturing under QMS: We developed a working prototype and helped Sienna define a formal Product Specification, a critical early phase of GMP development. The transfer to GMP manufacturing for clinical supply and preparation for commercial production included:

• Repeatedly producing the material under all the necessary controls to ensure the material meet all criteria of the formal Product Specification
• Establishing a process flow diagram based on the R&D process and control points for In Process Quality Control (IPQC)
• Developing a Manufacturing Master Record (MMR), including Master Batch Records (MBR) and a Bill of Materials with qualified suppliers
• Process development to increase the standard batch size 100×
• Process Failure Mode and Effects Analysis (pFMEA) to identify the risks in the material manufacturing
• Several iterations of robustness work to ensure a consistent manufacturing process at commercial scale
• Successful audits of nanoComposix to ensure QSR & ISO13485 requirements were met

Fortis Life Sciences is currently producing clinical supply material on-demand for this client and preparing for commercial production.

This client was developing a fluorescent-based lateral flow device for commercialization and was seeking a partner to produce ultra-bright nanoparticles that would help them achieve their sensitivity needs for their assay, as well as lateral flow assay development and manufacturing partner.

After evaluating other nanoparticle and lateral flow development companies, they selected us to develop a novel ultra-bright reporter particle for their assay and perform the assay development needed for pilot manufacturing. Over several months of collaboratively working with the client on particle and assay development, we enabled them to meet their rigorous sensitivity targets for the project and provided all the necessary methods and SOPs for pilot scale manufacturing.

Process development included:

• Producing test reports and cataloguing in the design history file during the R&D stage
• Finalizing a product specification and conducting an FEMA
• Drafting manufacturing methods for each step and producing batch records for prototype runs
• Qualifying raw material suppliers and receiving materials under the QMS
• Holding design review meetings to review the specifications, manufacturing and test methods, and performing hazard analysis
• Performing engineering runs to deliver released batches to the customer
• At the end of the project, all manufacturing methods and the complete design history file was transferred to the customer

For this technology transfer, the client contracted with us to assist in transferring their nanoparticle-enabled immune-stimulant technology from the university lab where it was developed to a commercial lab and to begin to establish manufacturing SOPs and to scale up synthesis production. We worked closely with the client to ensure the procedures were comprehensively documented for successful transfer to outside laboratories while maintaining material quality and reproducibility. Our team also investigated potential scale-up options, which would be required to reduce costs and produce the material at the target price-points for their end application.

Technology transfer steps included:

• Our scientists traveled to the university to observe and meticulously record every detail of the synthesis performed at the university
• Equipment and reagents were exactly duplicated for a successful repeat synthesis at our facility
• We conducted a preliminary sensitivity analysis to determine the variables that affected the critical parameters of the synthesis
• Our team drafted manufacturing methods at the small scale and documented additional details at critical steps
• Investigated scaling 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

This customer had been producing a proprietary topical therapeutic with a nanoparticle component and required a second supplier for their commercial technology. nanoComposix worked with them to replicate their established synthesis protocols, testing, and release procedures under our QMS so that we could be qualified as a second supplier for the nanoparticle component.

GMP process development included:

• Client provided us with their existing Manufacturing Master Record (MMR) and Batch Records and the synthesis was repeated in our R&D laboratory.
• After developing a Quality Plan for the project, our team transferred and adapted the Batch Records and related into our QMS and performed engineering runs to qualify the process
• Additional test methods were developed and validated and new suppliers were qualified
• We produced a cGMP compliant qualification batch and delivered the material to the client for evaluation
• At the successful completion of the project, the client approved us as a verified second source
• We were reviewed by the Client’s Notified Body and added as a Crucial Supplier to the Client’s CE Certification.
• We became the primary supplier of the material to the client