In which ways has CordenPharma expanded its footprint over the past 18 months?

CordenPharma is a leading, full-service CDMO supplying APIs, excipients, and drug products. Over the past year, CordenPharma has been extremely busy with supplying lipids to support vaccine manufacturing, as well as many other new products related and unrelated to COVID-19. We have been actively expanding our footprint and acquired three new facilities from Vifor Pharma, related to oral solid dosage drug products, and announced a large capex program where we invested heavily in new capacities and technologies, such as expanding our highly potent oral solid dosage drug product manufacturing at CordenPharma Plankstadt (DE). In addition, we signed a partnership agreement with Wacker to jointly develop know-how and manufacturing processes for formulating Lipid Nanoparticles (LNPs), and are in the process of building out our small-scale Peptide Centre of Excellence manufacturing unit in Frankfurt to support early-stage clinical trials with GMP manufacturing.

How is CordenPharma involved with green chemistry?

Green chemistry entails the methods we employ to reduce the use of certain organic solvents, and how we run our processes more volume-efficiently than in the past. Because producing multiple hundreds of kilograms of peptides per year leads to an extensive amount of waste, the CordenPharma Peptide Centre of Excellence is collaborating with PeptiSystems, a Swedish-based developer of instruments, for peptide and oligonucleotide therapeutic process development and manufacturing based on flow-through column technology. They have introduced an innovative solution to reduce the footprint impact and improve the Process Mass Intensity (PMI) of peptide manufacturing processes. PeptiSystems has developed an innovative concept that allows for the manufacturing of peptides in a continuous mode, which reduces solvent consumption and corresponding waste by at least 40% in all peptides produced by Solid-Phase Peptide Synthesis (SPPS). The company has also invested in an expansion of our specialty lipids production using Supercritical Fluid Chromatography (SFC) technology for compound separation, an efficient and cost-effective process for purifying lipids and pharmaceutical drug substances. SFC is an eco-friendly and sustainable technique that utilises reclaimed CO₂, coupled with online carbon dioxide recycling, resulting in a greener approach to manufacturing highly pure complex lipids.

How has the pharma landscape evolved since the onset of the pandemic?

With the pandemic, we have however seen regulatory changes and approvals accelerated, with the hope that this remains the case for the future. The investment and competitive climate has largely remained the same, with larger CDMOs still holding the largest market share.

I believe that the push towards local manufacturing, introduced by the Trump administration, will continue, especially with logistics disruptions having an impact on many supply chains. 

With a shortage of skilled labor, how does CordenPharma attract and retain talent?

The labor pool is often dependent on the country of operation and physical location of a company. In Colorado, despite significant competition, CordenPharma still managed to hire approximately 100 people in 2021. Quality talent is more difficult to attract in today’s environment, and that is why we aim to be flexible and attractive to younger generations, offering good career opportunities and creating a company culture where people want to work.

What is CordenPharma’s vision and growth strategy moving forward?

The US is the most important market for CordenPharma. Currently, we only have two sites in Boulder, but would love to expand our manufacturing footprint within the country. Our business is structured around five Technology Platforms – Peptides, Lipids & Carbohydrates, Highly Potent & Oncology, Injectables, and Small Molecules – with the goal to provide fully-integrated services to our customers. The Vifor Pharma acquisition aligned well with our strategy to broaden our CDMO capabilities. For example, in our Small Molecule platform we had only been heavily active on the API side but were lacking drug product capabilities. With the new acquisitions, we have closed the gap in our drug product offering with increased capabilities and capacities in the manufacturing of non-sterile speciality drug product dosage forms. With the addition of the three new facilities, the company’s global network now consists of 12 facilities - 11 GMP sites and one R&D laboratory - supported by approximately 2,600 employees.

CordenPharma’s ultimate goal is to have sufficient capabilities and capacity for seamless support from early-stage through to commercial manufacturing. Through our growing network of cGMP facilities across Europe and the US, we aim to continue to translate complex processes and projects at any stage of development into high-value products. We aim to continue our growth as one of the leading CDMOs, being driven by expert science and technology.