The full peptide package
CordenPharma has invested to cover the whole peptide supply chain. We spoke with company executives
In recent years peptides have accelerated away from already high 8-10 %/ year growth rates, thanks mainly but not entirely to the success of GLP-1s in treating diabetes and obesity. That has led to new challenges, most obviously the capacities needed to supply them at tonne-scale, but also during the early stages.
Even more than most APIs and finished dosage forms, peptides have become more sophisticated in recent years. Many are conjugated with fatty acids or small molecules, which requires additional skills in lipid and small molecule chemistry. That has made their supply chain more complex too, which CDMOs like CordenPharma are addressing.
“ The beauty of CordenPharma is that we cover all of these technologies within our six technology platforms,” says Dr Mimoun Ayoub, global head of the company’ s peptides and oligonucleotides platforms.“ We reduce that complexity by having all of these skills under the same roof. We have small molecule sites that can support the production of non-peptide parts, such as side-chains, and sites for peptide development, manufacturing and conjugation.”
All of these services are integrated into drug product( DP) manufacturing, Ayoub adds. The company also has capabilities in injectables and oral solid dose( OSD) formulations for peptides in close proximity to each other in Europe. The company also has high potency and peptide manufacturing capabilities in the US, currently lacking only DP there.
Need for speed
For first-in-human( FIH) clinical trials, CordenPharma’ s site in Frankfurt carries out stand-alone early peptide
Early-phase clinical-scale manufacturing at Frankfurt
synthesis, focusing on pre-clinical and Phase I-II supply with the emphasis on agility, flexibility and speed. These services are deliberately kept apart from late-phase validation and commercial, where the objectives are completely different. Instead, the small and medium scale site at Liestal, Switzerland, and the large-scale facility in Boulder, Colorado, handle these.
“ The goal at Frankfurt is to support customers with speed-to-market. You can only keep that agility if you don’ t have that mix of commercial and early phase at the same site,” Ayoub says.“ We don’ t want to give customers the perception that we are only a large-scale manufacturer. We have a very wide bandwidth from very small to very large.”
The Frankfurt’ s site’ s capabilities span solid- and liquid-phase peptide synthesis( SPPS and LPPS), plus all kinds of conjugations. Batch sizes range from a few tens of grams up to a few kilos. It also has all the downstream capabilities required.
In addition to Frankfurt, the injectables site at Capanago, Italy, has seen major investment in the last three to four years. The formulation development laboratory there has doubled in size and can now house about 50 R & D scientists handling pre-formulation, formulation and analytical development.
“ We found that not getting access to these types of development capabilities was quite often the bottleneck customers were experiencing,” says Dr John Cameron, global head of the injectables platform.“ Almost all injectable projects require some formulation development before they can go into GMP manufacturing.”
Two new lines will come onstream at Capanago in 2028 and 2027 respectively: a high-speed, late-stage line for prefilled syringes( PFS) and cartridges; and a flexible line that will
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