Decades of expertise as a CDMO for microparticles and other polymeric-based parenteral drug products
Evonik is the world’s leading CDMO for microparticles and other polymeric-based parenteral drugs including nanoparticles and implants that are designed for extended or targeted release. In addition to providing full project support from feasibility through to scale-up, commercial supply and aseptic filling, we are uniquely positioned to provide the perfect excipient solution from our RESOMER® portfolio to match your target release profile and other API or formulation requirements. Our process knowledge in the encapsulation or precise hot melt extrusion of nanoparticles and microparticles for a CDMO is unparalleled. Our multi-purpose, FDA-inspected U.S. facility, as well as other CDMO sites in Canada and Germany with labs and cleanrooms for polymeric drug delivery can further help to reduce project risk and accelerate speed to market.
An integrated portfolio of CDMO services for microparticles, nanoparticles and drug-loaded implants
Evonik is the only known global CDMO partner that can make or take your API, supply our own excipients, develop the microparticles, nanoparticles, implants or in-situ forming-based formulation and manufacture and fill the finished drug product at clinical or commercial volumes. This fully integrated portfolio of parenteral excipients and services of contract development and manufacturing organization for microparticles and other delivery technologies can be leveraged by customers to optimize performance, boost patient compliance and differentiate their product brands. We routinely help customers to achieve the desired release profile from days to weeks, or months to a year or more for systemic delivery with efficacious plasma levels. Our extended release CDMO capabilities for microparticles and other polymeric drug products can also be applied across various routes of administration for localized delivery at sites such as the knee, eye, brain, tumors, sinus and spine.
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CDMO services for microparticles and nanoparticles: continuous encapsulation
We have more than 40 years of microencapsulation expertise in making polymeric nanoparticles and microparticles via continuous solvent extraction. The emulsion-based process is reproducible, scalable to commercial batches, and can be used to tune, control or modulate the size of drug particles to optimize drug functionality or extended releasing. Additional outcomes of our proprietary technologies can include reductions in needle size, lower injection volumes and the injection of a higher percentage of microparticles. As a CDMO specialist for microencapsulation, we can also provide a range of emulsion-based process technologies such as solvent evaporation and phase separation, as well as emulsion generators and other particle processing techniques including solvent displacement and fluidized bed coating.
CDMO services for drug-loaded implants: precise hot melt extrusion
Our detailed understanding of interactions between polymer and precise hot melt extrusion process technologies enables us to specialize in the development of injectable, drug-loaded implants. By enabling the continuous co-extrusion of the API within the extended release matrix, our technologies can precisely control content uniformity irrespective of target shape or diameter for the consistent extended release of small molecules and peptides over periods of up to a year or more. Both single matrix or coaxial implants in diameter sizes from 0.3 mm to 2 mm can be supplied as rods, films, ribbons and other shapes. Proprietary post-extrusion processing methods can also be utilized to control burst and tune the releasing of drug for specific applications including ocular delivery.
CDMO services: aseptic filling of powders, liquids and suspensions
Regardless of your benchtop, clinical or commercial batch requirements under a project of contract development and manufacturing organization for polymeric microparticles, nanoparticles, and drug-loaded implants, our cGMP manufacturing facilities in Birmingham USA and Vancouver Canada can help to provide quality consistency and supply security. These modern facilities are designed for the sterile manufacturing of parenteral drug products and licensed to handle high-potency APIs and controlled substances. Automated, semi-automated and manual systems are available for the aseptic filling of parenteral drugs in powder, suspension or liquid forms into vials. All aseptic filling and lyophilization is conducted in ISO 5 (Grade A) isolators. To support the filling of highly specialized drug products such as personalized medicines and orphan drugs, we have established a fully-integrated line with SKAN isolators and GEA lyophilization technology that can aseptically fill powders, liquids and suspensions into vials up to 50 mL in size.
CDMO services: analytical method development and characterization
As a leading CDMO for microparticles and other polymeric-based drugs, we can provide customers with a range of analytical services out of our labs in North America and Europe. These method development and validation services can cover the cGMP characterization of polymers, raw materials, formulations and drug products according to ICH and USP guidelines. Analytical methods include molecular weight determination, particle size, distribution and concentration, surface charge, and protein analysis. Additional services include the development of protocols, report writing, stability storage and testing.