Development and analytical services for your peptide
Peptides are an important class of therapeutic compounds used against a variety of diseases including cancer, diabetes, viral infections, and chronic pain. Since the introduction of insulin, more than 80 peptides have reached market approval and many more are in research and development phase. Their strong potency, high selectivity and generally low toxicity make them a valuable tool for current and future therapies. Peptides usually comprise fewer than around 50 amino acids with a molecular weight of up to 6 kDa. While peptides and proteins are composed of the same building blocks, i.e., amino acids, they require different strategies during drug product development and analytical characterization.
Challenges of developing a peptide drug product
Despite their promising features, peptides can suffer from unwanted self-association, aggregation, fibrillation, adsorption to surfaces and chemical degradation. Their solubility and stability can be strongly affected by the solution pH, their concentration, and the buffer/excipients components. All these aspects need to be considered during formulation development, where optimal buffer conditions, suitable counter-ions and other stabilizing excipients need to be selected specifically for each compound. Coriolis is experienced in obtaining stable and robust peptide formulations and offers a range of stability-indicating and phase-appropriate analytical methods tailored to peptide characterization.
Peptide formulation types
While aqueous peptide solutions are the widely preferred, a liquid formulation can be difficult to achieve when the peptide solubility is insufficient. In these cases, a lyophilized formulation may provide improved stability and may be a suitable alternative at early-stage development. Our formulation scientists will tailor the formulation plan to your product characteristics, development phase and target product profile (TPP).
Coriolis is your expert partner for the development of peptide products
Each peptide is unique and presents unique challenges. Only a combination of knowledge, expertise and state-of-the-art analytics can drive the design of a fit-for purpose study plan to successfully tackle all those challenges to ease the path to a successful product. Our experts have the knowledge and the expertise to advise for solutions to issues like solubility, the impact of counter ions, as well as experience at formulating at high peptide concentration to minimize hurdles like gelation, fibrillation or chemical degradation.
Specialized services for your peptide product
Coriolis science-driven solutions are based on our deep understanding of the specific challenges of developing a peptide drug product. Our expert scientists will devise dedicated study designs tailored to the needs of your product and development phase.
Solubility optimization and pH adjustments
The aqueous solubility of a peptide is highly dependent on the solution pH. Thus, a stable formulation should be in an optimal pH range where solubility is maximized and chemical degradation e.g., through hydrolysis or deamidation is minimized.
Coriolis is highly experienced in obtaining stable peptide formulations by selecting a suitable composition of stabilizing excipients in a knowledge-driven development program. With our large portfolio of analytical techniques tailored for peptide characterization, we perform stability and forced degradation studies to identify critical degradation pathways and chose the best formulation approach.
High concentration peptide formulation development
High concentration formulations for e.g., subcutaneous injection can be a valuable alternative to intravenous application. For some applications, such as intravitreal injection, high concentration formulations are the only viable option.
We develop high concentration formulations for liquid as well as lyophilized drug products. Our formulation scientists are experienced in overcoming the challenges related to high concentrations including aggregation, viscosity, syringeability and manufacturability.
Low concentration peptide formulations
Highly potent peptides such as hormones require a low concentration formulation. The development of such products comes with certain challenges such as surface adsorption during manufacturing or the need for high-sensitivity analytical characterization.
Our formulation scientists have many years of experience in developing low-dose drug product formulations both as liquids and lyophilized powders. We offer a large portfolio of specialized analytical techniques and develop sensitive characterization methods specific for your therapeutic peptide.
Development services for your peptide product
Explore our large portfolio of development services. In a unique collaborative approach, we individually design each study to meet your expectations and the needs of your current development phase. You will benefit from the scientific experience and advise of our expert scientists to achieve your development goals faster and with a higher chance of success.
Analytical services for your peptide products
Choose from a large set of analytical techniques in a variety of categories or get our expert opinion on the most suitable methods for your analytical challenge. We offer standardized analytical methods for many common sample types and perform dedicated method development specific for your analytical challenge and drug product. Explore our analytical portfolio ranging from discovery phase analysis to lot release testing methods.
Our know-how related to peptides
Coriolis is a science-driven service provider. We perform internal research projects with academic and industrial partners to develop new technologies and create in-depth knowledge, which directly benefits our client projects. Our internal Unit Science & Technology, hosting PhD candidates and Postdocs, also actively contributes to the scientific community with numerous peer-reviewed publications each year. Explore our latest publications, articles, and webinars.
Muhammad Umar, Nils Krause, Andrea Hawe, Friedrich Simmel and Tim Menzen
Other product types
We tailor our services to your specific product type and development phase. In a unique collaborative approach, our expert scientists focus on your scientific question or development milestone and support your drug development program with their many years of experience. Select your product type to learn more about our services.