Manufacturing Solutions for Nanomedicine
Nanomaterial Synthesis & Manufacturing in Compliance with cGMP/QSR Standards
Our proficiency in nanomaterial fabrication spans from initial proof-of-concept to large-scale commercial manufacturing. We’re equipped to assist your project at every stage, from design and scaling to full production, ensuring compliance with cGMP/QSR standards and our ISO 13485:2016 quality system.
Leveraging years of demonstrated problem-solving prowess, our teams have achieved success in delivering intricate nanoformulations where other CDMOs have faced challenges. We specialize in addressing unique obstacles and crafting reliable, customized processes tailored to meet your product’s specific needs.
Extensive Nanoparticle Knowledge
We offer manufacturing assistance for particles categorized as drug substances, drug products, excipients, or components, with capabilities spanning from pre-clinical to Phase I and Phase II manufacturing.
Customized Project Strategy
We take a personalized, comprehensive approach to each project, ensuring alignment with your product, schedule, and regulatory objectives by integrating tailored processes, documentation, and testing protocols.
Rapid Technical Transition
We mitigate the risk associated with selecting a high-volume manufacturing partner by expediting technical transfers. With early subject matter expert (SME) engagement and meticulous attention to detail, we prevent errors and streamline the process and protocol transitions, avoiding delays.
Professionals Skilled In:
- Silica in various forms including solid and mesoporous, as well as colloids and coatings.
- Gold in Various Forms: Spherical, Rod-shaped, and Shell-like Structures
- Magnetite Variation: Iron Oxide Clusters and Single-Domain Cores
- Silver in Diverse Shapes: Spherical, Plate-like, and Cubic Structures
- Polymeric Nanoparticles Produced via Nanoprecipitation and Emulsion Techniques
- Lipid Encapsulation
- Tailored Transfers of Innovative Materials and Compounds
Infrastructure
- A laboratory and manufacturing area spanning 15,000 square feet.
- BioSafety Level 2 (BSL-2) Laboratory and Controlled Low Humidity Environment
- Adaptable cleanroom areas equipped with biosafety cabinets and chemical fume hoods.
- Adherence to ISO 13485, 21 CFR part 210/211, 21 CFR part 820, and FDA directives in all processes and protocols.
Accreditations, Registrations, and Licensing for Manufacturing Operations
- Certificate of Compliance with ISO 13485:2016
- Registration with FDA as a Medical Device Establishment
- California State License for Manufacturing Medical Devices
- Registration with FDA as a Drug Establishment
- California State License for Drug Manufacturing
Success Stories
Development and GMP Production of a Cancer Therapeutic Utilizing Mesoporous Silica
A pharmaceutical company approached Arcana Nano Particle to develop mesoporous silica particles as a key component in their cancer immunotherapy. Feasibility testing of several variants was completed to identify the key material properties and specifications needed to enhance the immunotherapy. Arcana Nano Particle developed processes to scale the fabrication 1000-fold and manufactured material under cGMP controls for pre-clinical testing.
Polymeric Nanoparticles Tailored for Immunotherapy at Scale
Arcana Nano Particle engaged in close collaboration with a client to comprehensively develop and manufacture a cutting-edge PLGA nanoparticle-based immunotherapy. Work began by successfully integrating the client’s API into a nanoparticle tailored to the unique requirements of the therapy and progressed through scale-up, process development, transfer to manufacturing, and the production of GMP material for Phase I and Phase II clinical trials.
Transfer of GMP-Compliant Topical Photothermal Therapy Techniques
A client sought a secondary supplier for a nanoparticle component in their topical acne treatment. Arcana Nano Particle received Manufacturing Master Records (MMRs) and Manufacturing Batch Records (MBRs) for all intermediates, successfully reproducing the synthesis of the nanoparticle component. Engineering runs were conducted using provisional batch records while additional test methods were created and confirmed. Arcana Nano Particle spearheaded the qualification process for all raw material suppliers. Subsequently, a cGMP-compliant qualification batch and commercial GMP batches were manufactured and supplied to the client.
Nanoparticle-based Photothermal Treatment for Hair Removal
Arcana Nano Particle collaborated with Sienna Biopharmaceuticals to co-create and produce a photothermal hair removal solution. This topical treatment incorporated silica-coated silver nanoplates, initially developed and refined by Arcana Nano Particle under research and development standards, later transitioning to the Arcana Nano Particle Quality Management System. Throughout the R&D phase, Arcana Nano Particle devised a method for fabricating and encapsulating nanoplates, facilitating prototype development and proof-of-concept validation through pilot studies.
Get in touch with us regarding your project.
Arcana Nano Particle holds accreditation under the ISO 13485:2016 standard
*Applicable to products falling under the purview of our ISO certification