Contract Research and Development Services for Nanomedicine
At Arcana Nano, we are the architects of innovation, seamlessly bridging the chasm between aspiration and realization within the dynamic sphere of nanotechnology and its interconnected disciplines. Our distinguished collective of experts stands at the vanguard of pioneering advancements, delivering unmatched proficiency in the domains of nanotechnology, chemistry, medical device innovation, quality assurance, materials science, and regulatory compliance.
Why Choose Arcana Nano Particle
Scientific Precision
We carefully choose performance indicators according to the specifications of the end product and pinpoint crucial parameters to ensure the creation of manufacturing and processing techniques that are both high-yield and reproducible on a large scale.
Creativity and Novelty
With our cross-disciplinary expertise, we consistently devise inventive solutions to challenging issues, delivering cost-efficient outcomes that surpass the expectations of our clientele.
Complete Transparency
Would you like to receive regular summaries of our data and findings, either on a weekly or monthly basis? We offer written reports, access to lab notebooks, and scheduled conference calls to address any inquiries and collaboratively determine the strategic course of the project.
Privacy and Security
Our collaboration, along with all activities and data pertaining to the R&D initiative, will be kept strictly confidential.
Foundational Expertise
Tailored Nanoparticle Synthesis, Refinement, and Expansion
Whether you require validation of a new therapeutic concept, personalized catalog offerings, or refinement and enhancement of your existing processes, our wealth of experience ensures we can advance your nanotherapeutic to your desired stage of development.
Surface Modification and Biofunctionalization for Precision Delivery and Compatibility
We utilize a range of methodologies to craft personalized nanotherapeutics tailored to your specifications, employing efficient and impactful chemical processes. Custom biofunctionalizations encompass antibodies, Fab fragments, VHH antibodies, RNA, and DNA, among others.
Medication Incorporation, Encapsulation, and Regulated Dispensation
We possess expertise in adjusting the characteristics of nanotherapeutics to ensure timely payload delivery and identifying the most efficient techniques for monitoring release.
Optimization of Optical and Infrared Properties for In Vivo Imaging, Theranostics, and Photothermal Treatment
We can assist you in choosing the appropriate nanoparticle composition to achieve the specific optical properties required for your nanotherapeutic application.
Design and Manufacture of Magnetic and Multi-functional Particles
We possess considerable expertise in the development of core-shell nanoparticles, which have been customized with biofunctionalization to suit particular applications.
Comprehensive Proficiency in Nanoparticle Characterization
Thorough characterization is conducted on both our standardized and tailor-made nanoparticles. Additionally, standalone characterization services for your nanomaterials are available on our services webpage. We’re also prepared to collaborate with you in devising customized assays for your nanotherapeutic needs.
Key Materials
Metallic Nanoparticles and Composite Materials
- Spherical Gold Nanoparticles, Gold Nanorods, Gold Nanoshells
- Spherical Silver Nanoparticles, Silver Nanoplates, Silver Nanocubes
- Iron Oxide Nanoparticles in Sphere Form, Magnetite, Colloidal Clusters of Iron Oxide
- Aluminum nanoparticles
- Platinum nanoparticles
- Nanoparticles of Various Metals and Metal Oxides
Nanoparticles composed of Silica
- Spherical Nanoparticles made of Silica
- Radial and MCM-41 Mesoporous Silica Nanoparticles
- Silica Nanorods with Mesoporous Structure
Nanoparticles and Composite Materials of Organic Origin
- PLGA Polymer Particles with Encapsulated Payload
- Polymer Particles Covered with Lipid Coating
- Phospholipid Vesicles
Key Analytical Strengths
Particle Structure and Shape
- Dynamic Light Scattering (DLS) – Measurement of Hydrodynamic Size and Polydispersity
- Transmission Electron Microscopy (TEM) – Assessment of Shape and Size for Inorganic and Nanoscale Materials
- Scanning Electron Microscopy (SEM) – Evaluation of Shape and Size for Polymeric and Nanoscale to Microscale Materials
- Brightfield Optical Microscopy – Examination of Shape and Size for Materials Ranging from Microscale to Macroscale.
- BET (Brunauer-Emmett-Teller) – Determination of Surface Area and Pore Size
Particle Surface Characteristics and Functionality
- ELISA (Enzyme-Linked Immunosorbent Assays) – Evaluation of Functional Performance via Direct and Indirect Methods
- Multiplexed Luminescence Assays – Simultaneous Identification of Multiple Analytes in a Single Sample
- LFA (Lateral Flow Assays) – Assessment of Qualitative and Quantitative Performance Relative to Test and Control Lines
- FTIR (Fourier Transform Infrared Spectroscopy) – Identification of Chemical Groups
- Zeta Potential – Evaluation of Surface Charge
Light Characteristics
- UV-Vis/NIR (Ultraviolet-Visible/Near Infrared Spectroscopy) – Measurement of Absorbance and Scattering across Different Wavelengths
- Fluorescence Spectroscopy – Qualitative and Quantitative Analysis of Fluorescent Properties
- Darkfield Optical Microscopy – Optical Technique for Detecting Nanoparticle Scattering and Coupling Effects
Characterization of Proteins
- BCA (Bicinchoninic Acid Assay) – Determination of Total Protein Content
- HPLC (High Performance Liquid Chromatography) – Analysis for Qualitative and Quantitative Determination of Proteins, PEGs, and Lipids
- SDS-PAGE (Gel Electrophoresis) – Qualitative and Quantitative Analysis of Proteins
- NanoDrop – Swift Protein Quantification with Minimal Sample Volume
Evaluation of Formulation Properties
- Endotoxin – Measurement of Concentration of Endotoxin (a Component of Gram-Negative Bacteria Cell Wall)
- DLS (Dynamic Light Scattering) – Assessment of Particle Stability and Polydispersity
- ICP-MS (Inductively Coupled Plasma Mass Spectrometry) – Quantification of Metal Ion Concentration
- Karl Fischer Coulometric Titration – Determination of Water Content
- FTIR (Fourier Transform Infrared Spectroscopy) – Analysis of Residual Reagents
Infrastructure
Within our laboratory, you’ll find:
- Our R&D and production labs span an area of 8,000 square feet.
- We have a Biosafety Level 2 (BSL-2) safety laboratory and a low humidity dry room.
- We maintain an ISO 8 cleanroom equipped with biosafety cabinets and chemical fume hoods.
- Our processes and procedures adhere to ISO 13485 standards and FDA guidelines.
Certifications, Registrations, and Licensing for Manufacturing
- Certificate for ISO 13485:2016 Compliance
- Registration for FDA Medical Device Establishment
- License for Drug Manufacturing in the State of California
- License for Medical Device Manufacturing in the State of California
- Registration for FDA Drug Establishment
Success Stories
Treatment of Cardiovascular Disease
Gold nanoparticles were coated with the client’s unique biologic for targeted therapy of cardiovascular disease. These nanoparticles, acting as a biocompatible framework, also enabled tracking of the platform’s pharmacokinetics. Arcana Nano Particle undertook a technology transfer of the client’s established analytical protocols and processes, successfully upscaling the production from milliliters to liters for future manufacturing. Additionally, we optimized the lyophilization and storage parameters for the therapeutic.
Nanoparticles for Immunotherapy Applications
Arcana Nano Particle collaborated closely with a client to develop and produce an advanced PLGA nanoparticle-based immunotherapy. The project commenced with the integration of the client’s Active Pharmaceutical Ingredient (API) into a nanoparticle customized to meet the therapy’s specific needs. This endeavor encompassed scale-up activities, process refinement, technology transfer to manufacturing, and the manufacturing of Good Manufacturing Practice (GMP) material to support Phase I and Phase II clinical trials.
Silver Nanoparticles with Antibacterial Properties for Incorporation into Wound Dressings
A physician client specializing in diabetic wound treatment sought Arcana Nano Particle’s expertise to produce silver particles for incorporation into wound compression dressings. The resultant product was featured in a medical case study focusing on wound and diabetic ulcer treatment. This collaboration underscores Arcana Nano Particle’s commitment to advancing medical solutions through innovative nanoparticle technology.
Nanoparticle-based Photothermal Treatment for Hair Removal
Arcana Nano Particle collaborated with Sienna Biopharmaceuticals to develop and produce a photothermal treatment for hair removal. This innovative therapy employed silica-coated silver nanoplates, which were meticulously developed and refined by Arcana Nano Particle. Initially, the nanoplates were synthesized and encapsulated under R&D protocols, followed by optimization under the NCX Quality Management System. During the R&D phase, Arcana Nano Particle devised a fabrication process for nanoplate encapsulation, enabling prototype creation and proof of concept demonstration in pilot studies.
Transfer of a GMP-Compliant Topical Photothermal Therapy
A client sought a secondary supplier for a topical acne treatment incorporating a nanoparticle component. Arcana Nano Particle received Manufacturing Master Records (MMRs) and Manufacturing Batch Records (MBRs) for all intermediates, successfully replicating the synthesis of the nanoparticle component. Engineering runs were conducted using provisional batch records, with the development and validation of additional test methods as necessary. Arcana Nano Particle oversaw the qualification of all raw material suppliers. Subsequently, a cGMP-compliant qualification batch and commercial GMP batches were manufactured and supplied to the client.
Silica-Coated Iron Oxide Nanoparticles Engineered for Targeted Delivery to Tumors in Living Organisms
Arcana Nano Particle engineered magnetite nanoparticles coated with a silica shell and functionalized them with a humanized anti-prostate-specific membrane antigen using covalent binding. To minimize non-specific binding, a mixed monolayer of polyethylene glycol molecules was developed on the particle surface. Feasibility testing demonstrated exceptional stability and specific targeting capabilities of these nanoparticles. In vivo studies confirmed targeted delivery and tumor reduction when the magnetic nanoparticles were heated through an applied alternating magnetic field.
From Development to GMP Manufacturing of a Cancer Therapeutic Utilizing Mesoporous Silica
A pharmaceutical firm enlisted Arcana Nano Particle to design mesoporous silica particles for integration into their cancer immunotherapy. Initial feasibility tests evaluated multiple variants to pinpoint essential material properties and specifications crucial for enhancing the immunotherapy. Subsequently, development advanced to scale-up endeavors, with Arcana Nano Particle devising processes to increase the production of this material by a factor of 1000.
Design and Development of a Cancer Therapeutic Utilizing Oligonucleotide-Conjugated Gold Nanoparticles
Arcana Nano Particle was commissioned by a sponsor of an oligonucleotide drug candidate to develop a bespoke gold nanoparticle conjugate. The formulation was meticulously designed, optimized, and characterized to ensure enhanced binding efficacy. Additionally, a complementary lateral flow immunoassay was developed by Arcana Nano Particle to facilitate rapid and straightforward functionality testing of these particles before in vitro or in vivo evaluations. Comprehensive characterization, including TEM visualization, UV-Vis spectra pre and post conjugation, and stability data, was provided to the sponsor by Arcana Nano Particle.
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