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Early Phase Development
Establish what the molecule will not tolerate before the formulation is committed.
Formulation decisions are made on very little material
Early formulation work happens when API is most scarce. A formulation decision that has to be reversed later brings new stability data requirements, comparability work, and a bridging study with it.
The first question at this stage is what the molecule will not tolerate, answered based on minimal material.
Parenteral formulation development
Most peptides and oligonucleotides are injectables, and the study design follows the intended route. We develop for intravenous, subcutaneous, intramuscular, intrathecal, ophthalmic and inhaled delivery, evaluating the parameters that decide an injectable: pH, osmolality, electrolyte composition and in-use stability.
That covers conventional sterile solutions and lyophilized formulations as well as the harder systems: lipid-based formulations, suspensions, and polymer- or particle-based approaches. The choice is driven by the molecule’s stability behavior.
Formulation is optimized against the filling format from the start. Sterile filtration behavior, fill format and process robustness are assessed during development. The development laboratories are on the same Wuxi City site as the aseptic manufacturing lines.
Oral peptide formulation development
Oral delivery is among the hardest problems in peptide development, and most candidates do not survive it. Instability in the gut, low permeability, and poor systemic exposure usually arrive together, so the first decision is whether the molecule can be formulated for oral delivery at all.
The first work is a developability assessment on minimal API: solubility, stability in both solid state and GI-relevant conditions, and permeability. That is enough to establish which leads justify an oral program before a campaign is committed.
For leads that survive, development moves to parallel screening of stabilizers and permeation enhancers, supported by physical form work and advanced formulation approaches — solid dispersions, self-microemulsifying delivery systems, and oral solid or liquid dosage forms.
From the start of feasibility to GMP clinical material typically takes six to eight months.
IND and IMPD-enabling manufacturing
Clinical drug product development and GMP manufacture are coordinated to support toxicology studies and Phase I supply, covering manufacture, packaging, labeling and batch release in one place.
Because formulation development, analytical development and API process development run in the same program, the specification the drug product is released against is the one the drug substance was developed toward.
Developability before commitment
Most oral peptide candidates fail, and the developability assessment exists to establish which will, on as little material as possible, before a campaign is committed.
For the candidates that pass, feasibility to GMP clinical material typically takes six to eight months.