Contract Development and Feasibility Studies
Feasibility answers one question: can this payload be delivered by this route at a performance level worth manufacturing. We run it in stages with a decision gate after each, so a program that will not work is stopped early and cheaply.
Stage one, payload assessment
We take molecular weight, logP, ionization and pKa, aqueous and lipid solubility, known degradation routes, current route of administration, and the regulatory classification in the target market. From that we state the dominant barrier and whether encapsulation addresses it. This stage is short and produces a written position, including the cases where our honest answer is that the limiting factor is intrinsic permeability or absent human safety data, and no carrier changes that. Partners often find this the most useful deliverable in the whole program.
Stage two, layer screening and characterization
We build candidate layer stacks and characterize them: particle size distribution and polydispersity, encapsulation efficiency, payload loading, morphology, and moisture content. In vitro release is run in media representing the intended route, with a stability-indicating assay so degradation is not mistaken for release. Accelerated and real-time stability start here, because shelf life often decides commercial viability before performance does. Output is a ranked short list with data, not a single proposal.
Stage three, biological and route testing
Depending on route, this stage covers ex vivo permeation using diffusion cells for topical or transdermal work, simulated gastrointestinal models for oral, and animal pharmacokinetics with an intravenous reference arm where an absolute bioavailability figure is needed. Intact analyte is measured by liquid chromatography with tandem mass spectrometry. Variability is reported alongside means, since a wide spread is a labeling problem even when the average looks good. Route selection matters here more than payload chemistry. A topical program can be answered with diffusion cell work at modest cost, while an oral peptide program needs the full sequence, and the budget difference between the two is an order of magnitude.
Commercial terms and deliverables
Programs are fee for service with a fixed price per stage and a written gate decision between stages. Deliverables are a technical report per stage, raw data, methods, and a specification draft for the selected candidate. Background intellectual property stays with its owner, the platform architecture remains Vegalab's, and payload-specific results belong to the partner under the development agreement. Timelines run from a few weeks for stage one to several months where real-time stability or animal work is involved. We quote both the elapsed time and the assumptions behind it, so a launch date is built on the study calendar rather than on hope.
Key facts
- Stability testing at defined storage conditions is required to support any shelf life claim (ICH Q1A(R2))
- Absolute bioavailability requires an intravenous reference arm in the pharmacokinetic design (FDA guidance, Bioavailability Studies Submitted in NDAs or INDs: General Considerations, 2022)
- Ex vivo skin diffusion cell testing is the recognized method for dermal penetration assessment (OECD Test Guideline 428)
- Bioanalytical methods must be validated for selectivity, accuracy, precision and lower limit of quantification (ICH M10, 2022)
- Formulation development should identify critical quality attributes and link them to process parameters (ICH Q8(R2))
How our delivery technology applies
The screening stage is where multi-layer construction pays for itself, because each candidate differs in one assigned function rather than in a whole recipe. Swapping the outer layer changes gastric survival without touching the oxidation barrier at the core, so results are interpretable and the winning stack can be explained to a regulator rather than discovered by trial and error.
Request the stage one assessment scope and fee schedule.
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