Contract Development & MANUFACTURING

Our Contract Design and Development

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At Matregenix, we specialize in providing contract design and development services for nanofiber technology. Our team of experts will support you from the development of your nanofiber concept or prototype all the way to bringing it to the market. We understand the importance of simplicity, which is why our first step is to learn about your target application and design input requirements, and then compile a target product specification for your concept or desired product. This approach allows us to quickly determine the project feasibility before moving forward with a full development plan.

We have established formulations that cover a wide range of properties, which allows us to accomplish this task quickly and deliver prototypes for initial evaluation. Our team will communicate regularly with you throughout the process to provide project updates and ensure that your needs are met.

With our contract research services, our customers can take advantage of the wealth of knowledge and experience of Matregenix's R&D team in the nanofiber production and development of nanofibers for a wide range of applications. Trust us to turn your nanofiber concept or prototype into a market-ready product.

We offer a comprehensive suite of services tailored to our client's needs, supported by flexible business models:

Large-Scale Manufacturing Services

At Matregenix, we are a trusted supplier of nanofiber materials for a wide range of applications including Contract Design and Development. We have invested significant time and resources in scaling our manufacturing processes and maximizing throughput to reduce costs. Our large-scale manufacturing capacity is powered by our proprietary TURBO spinning technology, allowing us to produce high-quality nanofiber composites and nanofiber materials efficiently and economically.
We offer nanofiber materials in customizable roll forms with different widths to meet our clients' specific needs. Our advanced facilities ensure consistent quality and performance, making us a reliable partner for large-scale nanofiber production. Additionally, we provide tailored solutions for various industries, including medical, industrial, and consumer applications, ensuring our products meet the highest standards of excellence.

Our Services
  • High-Volume Production: Capability to produce large quantities of nanofibers to meet industrial demands.
  • Customized Solutions: Tailored nanofiber properties and compositions to suit specific application requirements.
  • Advanced Technology: Utilization of state-of-the-art electrospinning techniques for superior quality and consistency.
  • Scalability: Flexible production lines to accommodate both small batches and full-scale manufacturing
  • Quality Assurance: Rigorous testing and quality control measures to ensure high performance and reliability.
  • Cost-Efficiency: Competitive pricing through optimized production processes and economies of scale.
  • Rapid Prototyping: Quick turnaround times for prototypes to accelerate product development cycles.
  • Technical Expertise: Access to a team of experienced scientists and engineers for support and innovation.
  • Roll Forms with Custom Widths: Provision of nanofiber materials in roll forms with customizable widths to meet specific client needs.
  • Substrate Coating: Capability to coat nanofibers on various substrates chosen by clients, providing versatility in applications.
  • Variable GSM Coatings: Offering nanofiber coatings with different grams per square meter (GSM) or as standalone membranes, tailored to application requirements.
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Design and Development of Clinical-Grade Biomaterials

Matregenix supports the development of your medical device from concept to market. Our team has extensive experience in Contract Design and Development, particularly developing biomedical constructs with a deep understanding of FDA regulatory requirements and risk assessment for nanofiber materials. Our ISO-certified clean rooms allow us to produce clinical-grade biomaterials with the highest quality and safety standards through our advanced Contract Manufacturing processes.

Our Services
  • Scaffold Design: We design and manufacture electrospun scaffolds in various formats, morphologies, shapes, and sizes. We customize attributes to match the client's requirements for cell growth, interaction, and compatibility with other materials or medical device components.
  • Concept Plans: We turn ideas into Target Product Profiles, considering technical feasibility, regulatory and IP considerations, pricing, and risks.
  • Feasibility Studies: We evaluate the scalability and reproducibility of processes from concept to lab scale, ensuring a smooth transition to production.
  • Pre-Design Control Studies: We conduct research studies to achieve the desired target
  • profile, optimize processes, and develop packaging and sterilization regimes. We produce samples for in vitro and other testing.
  • Design Control Modules: We perform verification and validation studies to establish process tolerances and ensure product consistency.
  • Regulatory Studies: We manage ISO biocompatibility studies with accredited third-party
  • suppliers and coordinate documentation, generating documents for the Design History File.
  • Pilot Production: We produce product batches with Certificates of Conformance to finalized product specifications.
  • Industrial Production: We offer contract manufacturing of the final product using customized Industrial Electrospinning Systems.
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Analytical Services

We provide analytical services for the developed electrospun constructs, supplying a certificate of analysis with all samples. Our capabilities in Contract Design and Development include morphological analysis, microstructure characterization, chemical analysis, surface chemistry analysis, residual solvent analysis, and mechanical testing for customized nanofibers and nanofiber membranes. Our analytical services include, but are not limited to.

Our Services
  • Fiber Morphology (SEM)
  • Fiber Diameter (automated image analysis software)
  • Pore Size (porometry and mathematical modeling)
  • Porosity (porometry, liquid intrusion, and gravimetric measurement)
  • Surface Wettability (contact angle measurement)
  • Structural Integrity (micro-CT scan)
  • Transition Temperature (DSC)
  • Surface Chemistry (FTIR, Raman, X-Ray photoelectron spectroscopy)
  • Residual Solvent (MS-GC)
  • Gaseous Component (TGA with FTIR)
  • Molar Mass Analysis (Size Exclusion Chromatography)
  • Mechanical Analysis (tensile testing, suture retention, life cycle, abrasion, DMA)

 

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Contact Us today to learn more about how we can help bring your ideas to life.