Partner with a global leader in CDMO services for polymeric-based drug delivery products
Profit from Evonik's decades of expertise as a CDMO developing long acting microparticles and other polymeric-based parenteral drug delivery products
Evonik is a leading contract development and manufacturing organization (CDMO) for long-acting microparticles and implants, as well as other polymeric-based parenteral drug products including nanoparticles and polymeric micelles. The performance attributes of Evonik’s polymeric formulations include extended drug release, local drug delivery, immune cell uptake, and enhanced drug exposure to meet the challenges of today’s new treatment modalities. Routes of administration encompass subcutaneous, intramuscular, ocular (intravitreal, subconjunctival, suprachoroidal), intra-articular, and intravenous.
When you partner with Evonik, you benefit from:
- Full drug product support from proof-of-concept feasibility studies and process scale-up, to cGMP manufacturing of clinical trial materials and commercial supply.
- Our RESOMER® and LACTEL® portfolios of proven lactide/glycolide-containing bioabsorbable polymers offering functional excipient solutions to dial in the desired drug release profile and other complex parenteral formulation requirements.
- Superior knowledge and experience with bioabsorbable polymers, parenteral drug delivery formulation development, and formulation processing - including sophisticated encapsulation and precise hot melt extrusion processing to make nanoparticles, microparticles and implants.
- Broad formulation experience with almost all classes of drugs - small molecules, peptides, proteins and nucleic acids.
- Reduced product development risk and faster time-to-market thanks to our multi-purpose, FDA-inspected U.S. facility, and other CDMO sites in Canada and Germany with labs and cleanrooms for polymeric drug delivery.
Integrated CDMO services for microparticles, nanoparticles and implants
We are the CDMO partner that can do all of this for you:
- Make or take your API
- Supply our own excipients
- Develop the microparticles, nanoparticles, implants or in-situ forming-based formulations
- Manufacture and fill the finished drug product in clinical or commercial volumes
By offering a fully integrated portfolio of parenteral excipients and parenteral drug product development services, we can optimize the performance of your drug product, boost patient compliance, and differentiate your product brand. We help our customers achieve the long-acting drug release profiles they desire, whether it is the delivery of drug for days, weeks, months, or a year or more following a single administration. We can administer our microparticles and other polymeric drug products via various routes including local delivery at treatment sites such as the knee, eye, brain, tumors, sinus, spine, liver and spleen.
Evonik's CDMO services for polymeric-based drug delivery products at a glance
Evonik's CDMO services for microparticles and nanoparticles
Microencapsulation stabilizes small molecules, peptides, proteins or nucleic acid drugs to maintain their biological, chemical and physical properties, while providing drug release over preprogrammed durations for systemic and local disease treatment. Evonik has over 40 years of encapsulation experience developing polymeric nanoparticles and microparticles by applying its flexible and scalable continuous, emulsion-based solvent extraction process technologies.
More specifically, Evonik’s continuous encapsulation is an emulsion-based process that is reproducible, scalable to commercial batches, and can be used to tune, control or modulate the size and matrix structure of drug particles to optimize drug functionality.
Benefits of our proprietary microencapsulation technologies include:
- Easier administration
- Smaller needle sizes
- Smaller injection volumes
- Longer durations of drug release
- Injection of a higher amount of microparticles
- Ability to formulate less potent drugs
Evonik's new continuous process for making bioabsorbable nanoparticles
Evonik now offers inline sonication technology for the production of bioabsorbable nanoparticles with encapsulated APIs. Evonik’s nanosonication process is a patent-pending, continuous, state-of-the-art nanoparticle process based on the precise generation and extraction of nano-sized emulsions. Nanosonication has many advantages over typical nanoparticle-generating processes such as antisolvent precipitation processes. With nanosonication, particle size is controlled with inline sonication energy and fluid dynamics. The critical lactide/glycolide (LG) polymer matrix structures are created by controlling the solvent extraction rate as the nano-emulsion droplets harden into nanoparticles. These and other nanosonication process features, along with regulatory preferred continuous manufacturing capabilities, makes nanosonication a robust, reproducible process that can be scaled up to afford a nanoparticle product with the desired performance attributes. Accordingly, Evonik’s nanosonication technology can support your product development from process feasibility to cGMP manufacturing of clinical trial materials and commercial product.
Highlights of Evonik’s nanosonication technology include:
- Robust processing using aseptic manufacturing or terminal sterilization
- Continuous processing preferred by regulatory agencies
- Mild process conditions maintaining drug integrity
- Production of <500-nm and <100-nm nanoparticles made with bioabsorbable lactide/glycolide (LG) polymers and PEG-lactide/glycolide di-block copolymers
- Production of decorated nanoparticles for immunotherapy drug products
- Scalable process performed under cGMP conditions
- Proportional down-scaling process capability for proof-of-concept studies
Our CDMO services for long-acting bioabsorbable implants
Hot melt extrusion (HME) is used to make many of the long-acting, drug-releasing implants on the market today. One of these implant products is a bioabsorbable implant that was developed by Evonik and is manufactured by us for our customer. Evonik has experience developing and manufacturing under cGMP very small ocular implants and larger implants for intramuscular or subcutaneous administration. Duration of drug release can range from weeks to months when using bioabsorbable RESOMER® and LACTEL® polymers.
We have special blending equipment, along with multiple extruders, cutters and other extrudate take-up equipment. We also have post-extrusion process technology that controls initial drug release of highly loaded implants.
At Evonik, we understand the interactions between polymer and drug within hot melt process conditions. Our technologies enable the continuous co-extrusion of an API within the extended-release matrix, which has the following advantages:
- Precise control of content uniformity independent of product shape or diameter, resulting in consistent extended release of small molecules and peptides over periods of up to a year or more
- Precise diameter control, which can be particularly critical for small ocular implants
- Fabrication of rods, films, ribbons and other shapes either with single matrix or coaxial internal structures
- Rod diameters and tape thickness from 0.3 mm to 2 mm
- Proprietary post-extrusion processing methods that can be used to control initial drug release and tune the sustained release of the drug.
Evonik's CDMO services for aseptic filling of powders, liquids and suspensions
Our cGMP manufacturing facilities in Birmingham, AL, USA and Vancouver, Canada offer quality consistency and supply security. These modern facilities are designed for the sterile manufacturing of parenteral drug products and are licensed to handle high-potency APIs and controlled substances. We use automated, semi-automated and manual systems 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 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 volume.
Evonik's CDMO services in the field of analytics
We provide customers with a range of analytical services out of our labs in North America and Europe. These method development and validation services cover the cGMP characterization of polymers, raw materials, formulations and drug products according to ICH and USP guidelines.
Our analytical methods include:
- Drug assay
- Molecular weight determination
- Particle size
- In vitro release testing
- Surface charge
- Protein analysis
- Water content
- Additional services: development of protocols, report writing, stability storage and testing
Want to learn more?
Get in touch with us to find out more about how we can move your polymeric-based parenteral drug project forward.
