Your partner for custom polymers for parenteral drug delivery systems
Evonik has been a leading supplier of pharmaceutical excipients and medical device materials for over 70 years. Our brands EUDRAGIT® and RESOMER® are well known in the medical device and pharmaceutical industry for their versatility, processability, and reliability. We offer standard and customized polymers for medical devices and oral and parenteral dosage forms, as well as contract development and manufacturing (CDMO) services for APIs, lipids, polymers, and long-acting injectables like LNPs, polymer microparticles, in-situ gelling systems, and drug-eluting implants. Our customers benefit from one partner for the entire value chain of drug products and medical devices.
CUSTOM EXCIPIENTS FOR NUCLEIC ACID DELIVERY
We offer custom GMP lipids and polymers for drug delivery and formulation, with a focus on RNA/DNA vaccines and nucleic acid-based therapeutics.
Custom lipid projects
At Evonik, we support our customers by combining our deep understanding of formulation, scale-up, and characterization of liposomes and LNPs with decades of expertise in process development, analytics, scale-up, validation, and GMP manufacturing. We can support non-GMP and GMP capabilities from small- to large-scale production.
Custom polymer projects for parenteral formulations
Polymers for gene delivery need to fulfil various requirements concerning e.g. micelle formation and -stabilization, self-assembly, release of payload, degradation rate, biocompatibility, toxicity, pharmacokinetics/biodistribution, and transfection efficiency. The scope of chemical composition and polymerization techniques applied is extremely broad. Evonik is familiar with all relevant polymer classes and the methods for making them.
Depending on the stage of your project, we can support you from polymer development and –characterization up to routine GMP production at small- and large scale.
Our development and manufacturing sites for pharmaceutical polymers
Our development and manufacturing sites for pharmaceutical polymers are located in the US (Birmingham, AL) and in Germany (Hanau/Darmstadt). We offer a dual manufacturing site approach on two continents for enhanced security of supply.
Darmstadt, Germany | European site for polymer development and production
- Opened in 2014 with additional recent expansions
- State-of-the-art facility for the clinical, commercial and custom production of PLGA and advanced biomaterials
- Multiple reactors at various scales
- Dedicated production line for parenteral biomaterials
- Additional small scale production line
- Polymer development laboratory
- Formulation development capabilities
Hanau, Germany | European site for polymer development
- Flexible scale for all stages of development
- Dedicated R&D laboratory for development, optimization and scale-up
- Development laboratory equipped with glass reactors ranging from 500 mL to 10 L
- Pilot plant equipped with stainless steel and glass reactors up to 1.000 L scale
Birmingham, AL, USA | North American site for polymer development and production
- Industrialized processes and capabilities
- Grade D cleanroom space under aseptic conditions
- GMP polymer synthesis at various batch sizes
- Milling, classification and pelletization capabilities
- Polymer purification w/ aqueous and organic solvents
- Drying capability for up to four projects simultaneously
- Custom packaging
- Separated unit operations for higher production throughput and accelerated supply
- Flammable solvent handling in clean room space
Harmonization with Evonik Science Center, Darmstadt
- Supply security through dual sourcing
- Harmonized purification and polymerization processes
WORKING WITH US ON A CUSTOM POLYMER PROJECT – WHAT YOU CAN EXPECT
The typical structure of the initial phase (lab familiarization) of a custom excipient project could look like this:
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First discussion, followed by signing of CDA |
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Customer provides detailed information on the product required, incl. technical package, if available |
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Pre-evaluation by Evonik to analyze technical and strategic fit |
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Second discussion to present the Evonik approach, align on general project structure, and clarify important questions |
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Evonik writes a proposal for the initial work packages |
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Third discussion of the proposal |
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Signing of proposal and start of work |
Later stages of a typical custom polymer project are structured as follows:
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Product specification definition |
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Analytical method identification |
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Manufacturing process scale-up |
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Non-GMP product manufacturing |
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Analytical method validation |
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Process transfer to manufacturing |
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GMP production and process validation |
Developing a novel polymer for gene delivery at Evonik – A practical example
This technology for a complex cationic, self-assembling polymer for gene delivery is being prepared for commercial manufacture at Evonik’s Birmingham site. The technology – known as CARTs - provides a broad customer base with access to well-characterized, non-viral vector systems.
Partner with evonik for long-term success
We only accept projects when we are convinced we can make a difference and meet the agreed targets and timelines. Our dedicated project managers track progress, keep you updated, and enable adjustments to agreed work packages to ensure a flexible, timely response to changing requirements.
In addition to basic skills such as polymer knowhow, GMP competence, regulatory expertise, and CMO experience, customers in the pharmaceutical industry come to Evonik for the following benefits:
- Dual manufacturing site approach on two continents for enhanced security of supply
- One-stop-shop for custom manufacturing of excipient polymers and final dosage forms
- Backward integration into PLGA and PEG polymers
- All quality certifications available: ISO 9001, IPEC-GMP, API-GMP, ISO 13485
