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.