Delivering Specialized Lipids, LNPs, & Carbohydrates
Developing the effective delivery of your xRNA-based drugs requires high-quality excipient building blocks from a trusted partner. CordenPharma is a global leader in pioneering the manufacture of lipid-based products for research and pharmaceutical development, boasting a remarkable four-decade track record.
No matter the scale or phase of development, we can support you in developing groundbreaking medicines with both custom and standard synthetic lipids. Our integrated facility network provides the flexibility needed to overcome challenges with innovative solutions throughout your project’s journey from early phase to commercial. At the heart of our success is a dedicated team of lipid experts leveraging proven methods and cutting-edge technologies to ensure the excellence of your final lipid-based products.
For customers requiring Lipid NanoParticles (LNPs) for various applications in the field of drug delivery and gene therapy, our LNP development and GMP manufacturing incorporates various technologies such as microfluidics and jet impingement, along with proper diafiltration / concentration. This allows you to manufacture targeted nanoparticle-formulated drugs, encapsulating your biological payload (e.g. mRNA, RNA, and oligonucleotides).
Our experience manufacturing cGMP carbohydrates, combined with end-to-end supply of custom APIs, brings added value to customers developing conjugated products.
Lipids
To support the rising demand for production of liposomal drugs using phospholipid excipients, CordenPharma draws upon an impressive history of excellence in providing specialized functionalities, such as longer shelf-life to give your API formulations a competitive advantage.
Our strong market position in synthetic lipid process development, scale-up and large-scale manufacturing (including custom and standard lipids) is underpinned by several Drug Master Files (DMFs) that we hold to even further expand your access to a broad range of lipid products and services.
Our Lipids Offering
- Synthetic lipid process development, scale-up and large-scale manufacturing
- cGMP certified supplier of highly efficient custom lipid excipients
- High-quality standard lipids (glycero-phospholipids, sphingolipids, phosphocholine, pegylated, and cationic lipids)
- Lipids for support of xRNA vaccine production including phosphocholine, pegylated, cationic / ionizable lipids and highly pure plant-based sterols ( e.g. CordenPharma BotaniChol® (cholesterol) and beta-sitosterol).
With API manufacturing sites in Europe and the US, offering a continuum of scales, our flexible network accommodates diverse preferences and demands. Our technology transfer system allows seamless scale-up, ensuring your program stays on track. Local regulatory teams adeptly manage global expectations, supporting DMFs and CMS preparation.
LNPs
Comprehensive LNP Development & cGMP Manufacturing
With our recently GMP-certified LNP manufacturing plant, your project will benefit from our complementary services for consecutive LNP formulation and batch-filling processes, all under one roof. This integrated approach helps minimize production time for your clinical material to ensure a more streamlined and effective process.
LNP Assembly Technologies
To achieve high encapsulation efficiency, we use two well-established LNP assembly and mixing technologies that are proven and scalable from development to linical and commercial activities:
- Impingement Jet Mixing (Knauer)
- Microfluidics (PNI – part of Cytiva)
Both technologies use the same principle for the formation of LNPs:
- Formed by a quick increase in the polarity of the environment induced by the rapid mixing of the two miscible high-velocity phases. This rapid mixing induces the supersaturation of lipid molecules
- Self-assembly into the desired structure without the wasteful need for size‐reduction methods
Carbohydrates
With over a decade of expertise in carbohydrate molecules, CordenPharma specializes in complex oligosaccharides. Our portfolio features multi-kilogram manufacturing of innovative carbohydrate products, including monosaccharide building blocks, GalNAc, and conjugates like glycolipids, phosphatidyl inositols, and glycopeptides.
Demonstrating our proficiency, we’ve successfully executed multi-kilogram cGMP manufacturing, delivering high-quality products with lot-to-lot consistency. Processes are developed following Quality by Design (QbD) principles and a manufacturing approach supported by Process Analytical Technology (PAT). We offer a unique back integration of non-GMP raw materials to support your carbohydrate projects.
Want to experiment with an immersive liposome lipid bilayer created from our 3D model?
Your Benefits > Our Strengths
1) Fast and Lean Process Development Approach > Scientific Expertise
Your project will benefit from our efficient, time-saving development of thousands of process steps using six-sigma.
2) Focus on Reliable Safety Expertise > Quality Is the Foundation of Every Step Your Project Takes
Rely on the integrity of our robust quality, regulatory compliance and manufacturing standards from initial process development through product delivery, supported by substantial global regulatory and filing experience (EMA, FDA, PMDA).
3) Go Green, Go Large > Unique Purification Capabilities
Take advantage of the largest capacity of complex lipids available globally through our SFC concept, a unique technique that reduces your scope 3 sustainability targets.
Seamless Integration Across the Supply Chain
Working and coordinating with several providers can be demanding and time-consuming when outsourcing a project. Our aim is to streamline your process, improve efficiency and reduce costs by consolidating multiple services in one organization. As your CDMO partner, we work alongside you to understand and anticipate your project needs.
We deliver them through seamlessly integrated technologies and services from across our expert global network that supports the development and manufacture of pharmaceutical and biotech innovators’ complex modalities. Our bespoke end-to-end solutions span your supply chain, covering all stages from drug development to commercialization.
