News & Press
Pharma Horizon, November 2017
: I am responsible for the Peptides, Lipids & Carbohydrates platform, where we support the customers from Phase I to commercial phase at any scale of development. The idea is to provide a one-stop-shop, a fully integrated solution to reduce the customer’s need for multiple suppliers. To that end, we not only provide the individual bio-organic molecules (i.e. peptides, lipids, carbohydrates), but also various conjugates and excipients. In fact, we see that the development of biological drug products as more and more about the conjugation of different biomolecules in all their possible combinations such as lipids-peptides, etc. We can produce the peptide at one of three sites, and perform the conjugation at yet another facility. To complete the full-service model, CordenPharma additionally provides the fill & finish for the final dosage drug product, thanks to our dedicated lines for peptide manufacturing.
: We see a strong demand in oncology, but in fact peptides touch many types of therapeutic areas – Diabetes, immune system, vaccines – it is very broad. Customization and personalization of drugs is increasing and I think that is where we’ll see a lot of growth in the future. Especially in the oncology sector, where physicians look at each patient, sequence the genotype of the cancers, and design a personalized cocktail of peptides which will treat the patient. Each patient has a unique cocktail, which includes from 5 up to 15 peptides. So it is not only about synthesizing all the peptides very rapidly, because these patients cannot wait, but about characterizing the end product, too. This is a real challenge since CDMOs / pharma companies need to provide regulatory agencies with a definite measure of product stability. How do we measure stability on a custom product that has to be shipped tomorrow? How do we ensure low toxicity without any toxicology studies? We do not have months to figure out how stable it is and to check the toxicology of the degradation product.
: We have to be pragmatic: we have to be able to very quickly supply APIs to our customer, and ultimately a patient, while working with generic analytical methods using the minimum amount of material, and without waiting for full stability studies. Those constraints can only be overcome by a high degree of synthesis and purification.
: Even though our sister company CordenBiochem in Frankfurt (DE) offers contract development of microbial fermentation, and is thus ideally equipped to manufacture large-scale peptides and technical enzymes as well as apply biocatalysis for the synthesis of intermediates and small molecules APIs, we manufacture biomolecules mainly by means of chemical synthesis. Yet we can provide peptides up to 50-100 amino acids long. Our scales go from milligram to tons of GMP-manufactured peptides, thanks to our cGMP facility CordenPharma Colorado located in Boulder, CO (US), which is fully inspected by all major regulatory agencies. This site also has long-standing and unique expertise in peptide precipitation, which is a key technology alternative to freeze drying. These processes are very scalable – this is a point where CordenPharma excels.
: On peptides, I think the trend is, as I said, towards ease of customization of the end drug product. We are still forming our strategy there, as we continue listening to our customers and keeping informed of market developments, so this is another big focus in the future for CordenPharma.