PEPTIDES & PROTEINS handle Phase I and II projects but will also be able to do small-scale Phase III and commercial campaigns. In addition to early phase API and DP, CordenPharma offers Qualified Person release of the DP and clinical trial services like secondary packaging and shipping to trial sites.
Coping with complexity
Complexity in the drugs themselves and their supply chains brings other challenges for innovators. There is no shortage of potential manufacturing partners, but they should preferably be able to supply both the peptide and the DP, which CordenPharma can. Currently over 95 % of all peptide drugs are injectables and the company offers both formulation development and GMP and non-GMP manufacture for these.“ That really streamlines the process and helps innovators go to clinical trials quickly,” Cameron says.
Both Ayoub and Cameron believe that the company is unique in having capabilities in both peptide APIs and DP across injectables and OSD. Building on synergies and eliminating redundancies takes out costs and saves time, the former says. It typically takes CordenPharma nine to 12 months to deliver a fully integrated project of API and DP, depending on the complexity of the drug. This can save at least three months of development time and speed is critical in FIH, because time is money in this industry.
“ In pharma, it’ s all about getting your product to market as soon as
Injectable PFS manufacturing using robotics at Caponago
possible,” Cameron notes. The first stage is getting it into clinical trials and the vast majority of clients here are biotechs funded by venture capital or similar means and seeking to hit certain milestones to unlock further funding. If they are delayed, the money might run out before a promising therapy comes to market.
Guarding against risk
Another aspect of the challenge, Ayoub says, is risk mitigation in supply. He cites one example in the company portfolio of a peptide conjugated through a small molecule linker to a lipid moiety. This requires other sites to work on the lipid part and deliver it to the peptide site, sharing all the necessary knowledge and the methods in an integrated timeline.
“ Imagine a customer who has to handle different partners for the peptide, the small molecule partner, the linker and the injectable or OSD manufacturing, and potentially also the packaging. It is hugely complex and if anything goes wrong or is delayed, they will have to co-ordinate all of the CDMOs to find a new manufacturing slot. CordenPharma manages all that for you.”
An integrated offer like this means that the process can be governed by a single master services agreement( MSA), which reduces bureaucracy and costs and frees up time to do more productive work. Whilst some believe that artificial intelligence will greatly simplify the process, there is little evidence of it yet in CordenPharma’ s experience.
“ There are a lot of synergies between API manufacturing and DP manufacturing but the two simplest are communication and analytics,” says Cameron. The process starts, in peptide drug substance, with making gram-scale amounts of API and the development of analytical methods.“ Once this is done, they can be transferred to Caponago, which can then start working straight away on analytics for the DP. If there is enough peptide available, they can also start to do the formulation development, which is often the critical part before you get into GMP manufacturing of the DP.”
Effective planning is critical here. If a customer comes with an integrated supply project for the peptide and the injectable, CordenPharma also supplies a global project manager in addition to those at the API and DP sites, who will be responsible for the entire global timeline, including communication between sites, ensuring that time and budget are met.
“ A lot of small biotechs don’ t have much manpower and would find it challenging to manage an API and a DP site,” Cameron says. Whilst this service is on offer to every customer, most of the interest comes from small to medium-sized biotechs.
Looking ahead, Ayoub stresses the need to stay ahead of the curve as the growth in demand for peptide development and manufacturing services shows no signs of slowing down.“ We always invest hand-in-hand with customers. We need to anticipate their needs, which is why we always seek their input with regard to their projections for the next few years so we can build the right capacities and put the right assets in place,” he concludes. ●
Dr. Mimoun Ayoub
GLOBAL HEAD, PEPTIDES & OLIGONUCLEOTIDES PLATFORM
CORDENPHARMA
J j mimoun. ayoub @ cordenpharma. com www. cordenpharma. com
MAR / APR 2026 SPECCHEMONLINE. COM
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