CDMO, CordenPharma, is enhancing lives with innovative research and formulation 

CordenPharma is a leading Contract Development and Manufacturing Organization (CDMO) for the development and manufacturing of APIs, lipid excipients, drug products, injectables, peptides, and Lipid Nanoparticles (LNPs). With a team of scientific experts, cutting-edge technology applications, and a global network of fully integrated services, CordenPharma delivers bespoke solutions spanning a complete drug lifecycle. 

Founded in 2006, the business was established with a simple mission to support global pharmaceutical and biotechnology customers with high-quality products that ensure the wellbeing of patients. Across 11 manufacturing facilities, CordenPharma provides innovators with complex modalities such as peptides, lipids, oligonucleotides, and injectables, along with a wide range of small molecules, which are organized under six technology platforms with tailored solutions to support specific project requirements. 

From clinical development to the commercialization of various dosage forms via automated packaging lines, full labeling, and serialization, CordenPharma boasts a wide spectrum of drug product capabilities including highly potent and oncological compounds. The business is also a global CDMO leader in pioneering specialized lipid-based products with synthetic lipid process development, scale-up, and large-scale manufacturing. Its specific capabilities include custom lipid manufacturing, standard lipids, LNP starter kits, and lipid excipient technologies like SORT-Coated LNPs and lipo-peptides to support, for example, ADME and DMPK activities. 

Committed to quality 

To learn more about CordenPharma’s evolution and capabilities, we sit down with Matthieu Giraud, Senior Platform Director, Global Lipids & Carbohydrates. “We have an excellent track record here at CordenPharma and we collaborate extensively with the research, pharmaceutical, and diagnostic sectors to deliver cutting-edge solutions that push the boundaries of science and contribute to saving lives,” Matthieu begins. “Our unwavering commitment to quality across all our products and services forms the bedrock of our reputation as a leading CDMO with specialized experience across multiple platforms. 

“We are driven by a deep passion for unlocking the potential of lipid-based therapeutics, and as such have built a team of lipid experts and technologies to produce highly pure lipids to support the extraordinary benefits they bring to our customers. This fuels our continuous pursuit of innovation, expanding our diverse portfolio with products that positively impact our customers and the lives of their patients. Our adaptability and responsiveness to dynamic market needs empower us to creatively transform challenges into solutions, supporting innovators in the development of groundbreaking medicines.” 

Also, with decades of experience in developing and manufacturing APIs, CordenPharma works with customers to deliver critical high-quality drug substances that seamlessly support their supply chain. Within the field of APIs, the company’s capabilities include peptides, oligonucleotides, HPAPIs, small molecules, and API support services like Supercritical Fluid Chromatography (SFC), flow chemistry, solid state, and purification. 

Ideal partnership 

In January 2024, CordenPharma announced a strategic alliance with pHLIP to develop the pHLIP LNP targeted delivery platform for RNA and gene therapies. Matthieu elaborates: “Inspired by the message provided by Katalin Karikó and Drew Weissman, who were awarded the Nobel Prize in medicine for modifying mRNA to be accepted into the body, that ‘the future of gene therapy is based on target delivery,’ we explored strategic opportunities to bring this revolutionary approach to our customers, and in that pursuit, we found pHLIP to be the ideal partner. 

“This alliance combines our LNP technology and good manufacturing processes (GMP) expertise with pHLIP’s drug development and proprietary pH (Low) Insertion Peptide (pHLIP®) targeted delivery technology to formulate pHLIP-coated LNPs for use by biopharmaceutical companies seeking to deliver mRNA-based and gene therapy payloads. 

New facility

“Such payloads can be used to treat cancer, inflammation, and genetic diseases, or to employ mRNA strategies for vaccination,” he continues. “We believe this novel pHLIP-LNP platform will greatly enhance the commercial viability and success of many pioneering RNA, DNA, and CRISPR therapies. It will also enable us to collaborate in developing and manufacturing small molecule drug payloads directly conjugated with peptides for biopharmaceutical companies seeking to selectively target cells in acidic diseased tissues. We already serve as the CDMO supplier in the GMP manufacture of peptides, drug conjugates, LNPs, and fill and finish, so this new alliance further builds upon our collaborative efforts.” 

Aside from the alliance with pHLIP, CordenPharma is exploring investment in several areas. “Our integrated network of facilities brings more than 200 years of experience to our projects, as well as 1.2 million liters of volumetric capacity and reactors ranging from 20 liters to 28,000 liters,” Matthieu explains. “Acknowledging the importance of LNPs as a key delivery platform for the therapeutics of the future, we initiated a strategic investment program at our sterile injectable site in Caponago, Italy, in 2020, to establish LNP formulation, development, and manufacturing facilities. 

“Similarly, to further support the clinical and potentially commercial demand of LNP-based therapeutics, we began building a new GMP LNP manufacturing suite in 2022 by extending an existing GMP area. The new site is strategically placed adjacent to the clinical-scale fill and finish facility to streamline end-to-end manufacturing operations from cargo molecule encapsulation to fill and finish in the final primary packaging container.” 

Ambitious growth 

As Matthieu looks to the future of CordenPharma, he reflects on the last 12 months. “2023 was a transformational year for us, which in many ways laid the foundation for our accelerated growth trajectory,” he says. “Most notably, we contributed to the launch of several new medicines for small to large patient populations, ranging from innovative orphan drugs with high unmet medical needs to breakthrough diabetes and obesity products. Throughout these projects, our purpose as a leading CDMO brought important value to innovators across the pharmaceutical supply chain. 

“This year, we are continuing to pursue our ambitious growth, and as part of a long-term strategic objective, we are striving for exceptional customer experience and strengthening our commitment to ESG, with a plan to imminently announce our SBTi targets,” Matthieu concludes. “Furthermore, we will continue to attract top talent and enhance our company culture through our people strategy. After all, it is the passion of people across CordenPharma and the wider industry that truly makes the difference in the lives of patients.”