LIPIDS & CARBOHYDRATES PLATFORM
Your Expert Partner For Standard & Proprietary
Lipids & Carbohydrates
- >> A specialized Lipids offering including custom and standard lipids (Glycero-Phospholipids, Sphingolipids, Phosphocholine, Pegylated, and Cationic Lipids).
- >> Lipids for support of mRNA vaccine production including Phosphocholine, Pegylated, Cationic Lipids and highly pure plant-based CP BotaniChol® (cholesterol).
- >> Fully-integrated service offering > from APIs to finished dosage and pharmaceutical services (clinical trial kits preparation, randomization and logistics).
- >> Backward integration for key starting materials > securing the supply chain in terms of costs & quality.
- >> Multiple manufacturing locations across Europe & the USA offering flexibility of supply.
CordenPharma is a well-known expert in synthetic Lipid process development, scale-up and large-scale manufacturing, including custom and standard lipids (Glycero-Phospholipids, Sphingolipids, Phosphocholine, Pegylated, and Cationic Lipids), for which CordenPharma holds several Drug Master Files (DMFs).
CordenPharma supports customers’ needs for Custom Lipids as Drug Delivery Systems or as APIs. Over the past several years CordenPharma has developed substantial expertise in Custom Lipid Synthesis (particularly in cationic lipids manufacturing). These lipid manufacturing services complement our offering of API and Drug Product services.
mRNA Vaccines Production
As a result of the COVID-19 pandemic in 2020, CordenPharma developed a straightforward, short synthesis of highly pure plant-derived cholesterol called BotaniChol® used in the production of lipids for mRNA vaccines.
Currently, the main quantities of cholesterol for industrial applications are extracted from wool grease of sheep or animal tissues. These sources involve the risk of Transmissible Spongiform Encephalopathies (TSEs) agents via human and veterinary medicinal products.
The new production process of BotaniChol® with non-animal origin cholesterol avoids any potential animal source of contamination, as it is based solely on chemical transformations starting with plant materials. The patented process plays an important role in overcoming the global shortage of lipids, and aiding in the production of more life-saving vaccines around the world to fight the pandemic.
In addition to our standard phosphocholine, pegylated and cationic lipids, BotaniChol® nicely completes our mRNA lipid offering for global partners involved in fighting the pandemic.
Over years of extensive experience, CordenPharma has gained expertise in the manufacturing of various aspects of complex Carbohydrates, including Oligosaccharides, covering major areas such as, but not limited to:
- >> Carbohydrate-based Vaccines (solution-phase oligosaccharide synthesis)
- >> Carbohydrate-based Active Pharmaceutical Ingredients (APIs)
- >> Manufacturing of Carbohydrate-based delivery systems (e.g. GalNac derivatives)
- >> Carbohydrate Conjugates for receptor targeting – conjugation to Lipids and / or Peptides
CordenPharma is uniquely positioned to support customers from initial mg- synthesis, in our R&D laboratory to kg-scale manufacturing under cGMP from either CordenPharma Switzerland or CordenPharma Colorado. We are well-equipped to handle long manufacturing sequences on a commercial scale (> 20 steps), including large-scale chromatography, and have in-depth know-how of analytical and regulatory requirements for this class of molecules.
CordenPharma’s ability to develop and manufacture a wide range of Bio-Organic APIs, Finished Dosage and Packaging in our network of facilities allows clients full access to integrated services. This results in a simplified supply chain, reduced risk and cost associated with technology transfers, and ultimately faster production and delivery timelines.