Coriolis Pharma

Precipitation at one pH. Degradation at another. Every peptide has a narrow window where it stays soluble and stable, and no two sequences share the same one. Find it on paper before you find it in your stability data. The Peptide Development Checklist walks through what to assess first: • Sequence liabilities and degradation pathways • pH range, buffer system and excipients • Liquid vs lyophilized strategy 15 risks in total, with what to consider for each.

Working with a low-dose peptide? At these concentrations, small losses add up fast. Peptide can adsorb to vials, tubing and filters, so recovery drops and your results stop reflecting what is in the formulation. High potency adds a second problem: exposure limits that shape your lab setup. The Peptide Development Checklist covers what to check early: • Material compatibility and process losses • Degradation pathways and analytical characterization • OEL/OEB, containment and safe handling 15 risks in total, with what to consider for each.

Taking a peptide into a pen or pre-filled syringe? The concentration you need may be more than the molecule can handle. Aggregation, viscosity and solubility limits tend to show up late, when changing course costs the most time and material. The Peptide Development Checklist helps you catch them first: • 15 peptide-specific risks across 4 areas • Why each one matters and what to check • Device fit, multi-dosing and liquid vs lyophilized decisions Use it before your next formulation decision, or share it with your CMC team.

Concentration feasibility studies consume API, and early-phase programs rarely have it to spare. Small-scale compounding carried the early screens here. UF/DF came in only for the later phases. The final stages ran directly in the prefilled syringe, so the last data set came out of the real container rather than a vial. What it delivered: approximately 40–50% lower viscosity, into an autoinjector-ready range, with monomer content above 97%.

Stability data from a glass vial tells you about a glass vial. The product ships in a prefilled syringe. On this program the late-stage stability studies ran directly in the PFS: stable behavior during storage, no increase in particle formation, and compatibility with autoinjector requirements. By the end of a subcutaneous project, a surprising amount of it is about the container. Four pages on the formulation work and the container work behind it.

A device tolerance decides the viscosity target long before the formulation work starts. On this program it was 20–25 mPa·s. Formulation and container cannot be handled in sequence. The packaging shapes the formulation, and the formulation constrains which containers stay available. Deciding them separately is where subcutaneous programs lose time. Download four pages on how the target was met, and what it took to hold quality while getting there.