Advanced Drug Delivery
Our portfolio of GMP biodegradable polymers, synthetic lipids, and functionalized polyethylene glycols enables you to create small- or large-molecule drug formulations with the optimized release kinetics and targeted drug delivery characteristics needed to maximize product efficacy. As you pursue successful commercialization in today’s complex regulatory environment, we offer:
- High quality
- Portfolio offering and customized solutions
- Solutions for a broad selection of active pharmaceutical ingredients (APIs), ranging from DNA and RNA to proteins
- Support in all phases of clinical development and commercialization
- Regulatory support by a dedicated team
To meet exacting regulatory standards, our production facilities in western Europe and all over the world feature ICH Q7-compliant systems for consistently high product quality, reliability of supply, and short delivery timelines. At every phase of clinical development and commercialization, we have the resources and expertise to support your critical development milestones.
PLA and PLGA biodegradable polymers for optimal release profiles
Use of our poly(D,L-lactic acid) (PLA) and/or poly(D,L-lactic-co-glycolic acid) (PLGA) biodegradable polymers can optimize the release kinetics of your final drug products, reducing side effects while improving patient comfort and compliance. Our wide portfolio of top-quality biodegradable polymers has an excellent track record of customer and FDA audits, manufactured in Europe to robust QC specifications that were developed with the end dosage form in mind. You also have the option of using our customization capabilities to manufacture a polymer with the characteristics you need.
Benefits of our PLA and PLGA polymer portfolio include:
- Optimization of your early formulation with the option of custom manufacturing of unique polymers
- Small- or large-scale GMP manufacturing based on your needs
- Technical support from our formulation and analytical experts
Polymeric platform for delivery of large molecules
The SynBiosys® biodegradable polymer platform makes it possible to create injectable sustained release formulations for virtually any class of biological API, eliminating pharmaceutical development hurdles. SynBiosys® encapsulates proteins and large peptides at high concentrations under gentle process conditions, preserving protein integrity and bioactivity, and can be used for a variety of final drug products.
Key features of the SynBiosys® platform include:
- Suitability for subcutaneous, intramuscular, and site-specific injectable formulations in the form of microparticles and implants with high API doses up to 100 mg/mL
- Duration and rate of API release can be modulated as required, ranging from a few weeks to six months
- Robust and scalable production with high yields and absolute control over particle size (5-100 µm)
- Clinically validated
- Supported by extensive biocompatibility and toxicity data packages, as well as in vivo biocompatibility and degradation data
Synthetic lipids for pharmaceutical applications
We are highly specialized in synthesizing top-quality GMP lipids for pharmaceutical applications and gene therapy, focusing on tailored manufacturing to meet your specific needs. We also offer a standard portfolio with optimized stability, solubility, and handling characteristics. If lipid blends are needed, we can provide lyophilization and spray drying.
Benefits of our lipids include:
- Support in every phase of development and marketing
- cGMPs and site standards that follow the concepts of ICH Q7
- Consistently high product quality from grams to tons
- Stability studies and analytical method development and validation
- Regulatory expertise and counsel from a dedicated team
- An excellent track record of customer and FDA audits
In addition to portfolio lipids, we offer custom manufacturing and complete support pertaining to lipids manufacture through all phases of development, from R&D to commercial. We especially excel at synthesizing
- Ionizable/cationic lipids
- Lipids conjugates
- PEGylated lipids
- Lipids for passive and active targeting, leveraging our patents/licenses and deep knowledge
Activated/functionalized polyethylene glycols (PEGs)
Functionalized/activated polyethylene glycols (PEGs) are essential for PEGylated therapeutic proteins used in drug delivery, and you can rely on us to develop and supply the commercial quantities you need. Our offerings include high-purity materials for use in investigational products at every phase of clinical development and commercialization, with overall supply chain security and benchmark quality – from pre-clinical to commercialization of final medicinal products. Product groups include:
- Linear MPEGs (up to 30 kDa)
- Branched PEGs
- Linear bifunctional PEGs (linkers)
- Multi-arm PEGs
These products can support a variety of applications: PEGylation of therapeutic proteins at every phase of clinical development and commercialization, linker substances for antibody drug conjugates (ADCs), or as part of medical devices such as biodegradable hydrogels.
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