Peptide Product Formulation

The aqueous solubility of a peptide depends on the solution pH, requiring a stable formulation in an optimal pH range to maximize solubility and minimize chemical degradation. Coriolis excels in peptide formulation development by selecting suitable stabilizing excipients. We use a wide range of analytical techniques to perform stability and forced degradation studies, identifying critical degradation pathways and choosing the best formulation approach.

High-concentration peptide formulations (approx. ≥50–100 mg/mL) enable convenient subcutaneous delivery. Our formulation experts develop robust liquid and lyophilized peptide products, addressing key challenges including chemical stability, solubility, and sequence-specific aggregation. We design tailored solutions that ensure manufacturability, stability, and optimal performance at elevated concentrations.

Highly potent peptides, like hormones, need low-concentration formulations, posing challenges like surface adsorption and requiring high-sensitivity analysis. Our scientists excel in developing low-dose formulations, both liquid and lyophilized. We provide specialized analytical techniques and sensitive characterization methods tailored to your peptide therapeutic.

Accurate identification and source attribution of particulate matter in biopharmaceutical drug products are essential for effective troubleshooting and comprehensive root-cause analysis.

Given the potential impact on product quality, patient safety, and regulatory compliance, rapid analytical turnaround is often critical.
Upon request, Coriolis experts provide accelerated, fast-track analytical services, enabling detailed characterization of particulate contaminants within a matter of days.

Freeze-drying of drug substance can improve stability, simplify storage and transportation, and support manufacturing flexibility. Coriolis provides comprehensive bulk freeze-drying support, including formulation optimization, cycle development, and process characterization tailored to the specific requirements of your biologic.
Our experts evaluate critical quality attributes and process parameters to ensure product integrity, efficient drying, and reliable reconstitution while supporting seamless transfer to clinical and commercial manufacturing.

Whether a liquid or lyophilized formulation is the best fit depends on your molecule, stability profile, and product requirements. Coriolis develops robust formulations for both liquid and freeze-dried drug products, balancing stability, manufacturability, and patient needs.
Using a science-driven approach, we evaluate formulation compositions, process conditions, and storage strategies to identify the optimal solution for long-term product performance and successful commercialization.