Advance your peptide characterization and formulation development
Peptide therapeutics are very attractive active pharmaceutical ingredients nowadays due to their good specificity and a more affordable production compared to protein therapeutics. 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 characterization techniques, formulation development is crucial to develop your peptide therapeutic into a stable drug product.
Get to know your peptide
Growing understanding of your therapeutic peptide and its behavior can overcome analytical and formulation challenges, allowing 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 detection and quantification of peptide-related impurities. Efficient, selective, and reliable separation-driven analysis techniques are required for:
- Peptides synthesized with natural or chemically altered amino acids
- Modified peptides to improve biological activity, selectivity, stability and solubility
- Complex peptide mixtures with diverse physicochemical properties
Specialized expertise and state-of-the-art analytical capabilities ensuring high quality results within an acceptable timeline:
- Ion-pair reversed-phase (IP-RP), ion exchange (IEX), hydrophilic interaction liquid chromatography (HILIC) and size exclusion chromatography (SEC) to separate and quantify therapeutic peptides and related degradation products
- High-resolution mass spectrometry (HRMS) coupled to LC for supporting advanced purity/impurity and identity determination
- Capillary electrophoresis (CE) for high resolution separation of peptide-related impurities
- Chiral amino acid analysis (AAA) for determination of enantiomeric purity
- Dynamic light scattering (DLS), microscopic flow imaging (MFI), and light obscuration (LO) for (subvisible) particles and aggregation studies
- Differential scanning calorimetry (DSC) for stability assessment
- Coulometric Karl Fisher (cKF) titration for water content determination in lyophilized peptide therapeutics
Our integrated analytical support
Our analytical services include method development, and subsequent method qualification and validation to ICH guidelines, drug product release testing and stability studies:
- Forced degradation studies (e.g., humidity, temperature, pH, oxidation)
- Photostability studies
- In-use stability studies
- ICH stability studies and testing
- Accelerated Stability Assessment Program (ASAP) studies for drug product prototype ranking and shelf-life predictions
Liquid Drug products
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 as well as the limited availability in early stages of the project, we strive to miniaturize 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. We can work on any of the following drug products:
- Solution in vials or prefilled syringes for parenteral injection
- Ophthalmic drug products like eye drop or eye injections
- Nasal spray
- Solution for inhalation
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 is a plus for your project. Eurofins CDMO is capable of producing both sterile and non-sterile drug products with all required analytics in-house.
Increasing stability
Stability testing of your peptide drug product is a crucial step within the formulation development process. In case the stability of the peptide is challenging, other services of our CDMO can come into scope. Whether it is an optimization of the formulation like adding an antioxidant, or there is need to change the dosage form, we are ready to take the lead. A freeze-dried drug product might be the solution to increase the stability of your peptide drug product.
To develop a freeze-dried drug product, your project can go through the following steps:
- Buffer and excipient screening
- Lyophilization screening of different concepts often supported by design of experiments
- Extensive analytical support including water content analysis
- Short stress studies and accelerated stress studies
- Freeze drying cycle optimization
- Transfer to GMP scale freeze-dryer
- Clinical production
Challenging peptides and drug products
Peptide drugs have many advantages but can be challenging in some cases.
- Does your peptide have a long peptide sequence?
- Is your peptide a large construct of multiple sequences?
- Has your peptide low solubility?
- Does your peptide aggregate?
Eurofins CDMO embraces those challenges by first understand them before opposing new routes. We are thrilled to bring your peptide drug product development up to speed.
The challenge can also lie in the drug product development rather than with the peptide properties which is 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.