Eurofins CDMO is aware of the benefits as well as the challenges associated with peptide drug substances and related drug products. Next to a broad set of characterisation techniques, formulation development is crucial to develop your peptide therapeutic into a stable drug product.
We bring deep expertise in peptide development and manufacturing, supporting programmes from early clinical stages through commercial supply. As a trusted CDMO, we combine robust process development, scalable GMP manufacturing, and rigorous quality systems to deliver complex peptides with consistency, speed, and regulatory confidence.
Efficient, selective, and reliable separation-driven analysis techniques are required for:
Growing understanding of your therapeutic peptide and its behavior can overcome analytical and formulation challenges, allowing for faster progress through clinical trials and successful delivery to patients. Peptides are prone to degradation, oxidation and other modifications posing additional analytical challenges which require sensitive and robust analytical methods for the detection and quantification of peptide-related impurities. Our analytical services include method development, and subsequent method qualification and validation to ICH guidelines, drug product release testing and stability studies.
Stability testing of your peptide drug product is a crucial step within the formulation development process. Whether it is an optimisation of the formulation like adding an antioxidant, or there is need to change the dosage form, we are ready to take the lead.
Peptide drugs are often formulated in liquid dosage forms for parenteral administration. Solubility of the peptide at the right dose as well as compatibility with the used excipients are key aspects. These aspects will be screened at the start of the project and form the fundamental base for further formulation development. Knowing the cost of the peptide drug substance, we strive to miniaturise the drug substance consumption in each step of the formulation development process.
Are you looking into formulating a cocktail of peptides? Eurofins CDMO has expertise to get your peptide mixtures in its final drug product form.
We can work on any of the following drug products:
When it comes to pharmaceutical development, stability is paramount. Many APIs face instability in aqueous phases, necessitating meticulous galenic studies to ensure prolonged stability. At Eurofins CDMO, we recognise the significance of scalability and commercial viability in achieving lasting stability. Our sterile manufacturing service portfolio is designed to elevate your API's stability, driving it to a higher stage of performance. With cutting-edge development laboratories featuring state-of-the-art laboratory scale freeze dryers, we embark on a journey to reshape drug stability.
To develop a freeze-dried drug product, your project can go through the following steps:
Clinical manufacturing of your developed formulation is the next step in which Eurofins CDMO can support you. Our expertise in upscaling and transfer to a GMP environment can benefit your project. Eurofins CDMO is capable of producing both sterile and non-sterile drug products with all required analytics in-house.
Eurofins CDMO embraces these challenges and has in-house expertise to support your peptide drug product development up to speed.
Challenges can also lie in the drug product development rather than with the peptide properties, especially in the case for solid peptide drug products. We offer all necessary services to formulate your peptide into a tablet, mini-tablets (multiparticulates), a capsule or powder for inhalation. In case you are interested in delivering your peptide to the colon, you can find out more on our Colon targeting page.
