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:
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.
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:
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:
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:
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
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:
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.