Preclinical formulation development is the early-stage work undertaken to assess a drug candidate's developability and identify viable formulation strategies before progression into toxicology (TOX) and ADME studies. It involves screening solubility, characterizing the drug substance, evaluating excipients and solvents, and producing prototype batches – using minimal API to generate the data needed to support confident decisions about a molecule's progression.
Early development decisions are critical in determining the success of downstream formulation, manufacturing and clinical programs. Limited API availability, complex molecule profiles and pressure to generate decision-enabling data quickly create significant constraints at this stage. Without rigorous early screening, programs risk costly setbacks during scale-up and regulatory progression.
Our discovery and preclinical development services focus on formulation screening and early developability assessment, using minimal API to generate the data needed to make confident decisions. We help you optimize solubility, bioavailability and absorption, identify viable formulation strategies and de-risk complex molecules well before scale-up begins.
Advance your program with confidence
- Generate decision-enabling data quicklyOur high-throughput screening delivers rapid turnaround – approximately six weeks – so programs progress without delay.
- Conserve limited APIOur workflows are designed for the constrained API availability typical of early development, helping you maximize the value of every milligram.
- Improve solubility and bioavailabilityTailored solvent and excipient selection, supported by thermodynamic and kinetic solubility testing, enhances downstream manufacturability.
- Prepare for TOX and ADME studiesPrototype batches and formulation insights help you enter toxicology and ADME studies with robust, data-supported materials.
- Identify viable formulation strategies earlyStructured developability assessment surfaces formulation pathways before scale-up, reducing risk across the development life cycle.
Why SGS?
As the world’s leading testing, inspection and certification company, our discovery and preclinical development services combine specialist formulation expertise with the analytical depth required to characterize complex molecules at the earliest stages of development. We apply solid-state and drug-substance characterization techniques – including DSC/TGA, XRF, XRPD, particle size analysis and nanomilling – alongside small-scale solubility screening, prototype infusion and precipitation assessment, and excipient and solvent selection.
Backed by our global testing, inspection and certification capabilities, we deliver the technical rigor, scientific independence and operational reliability needed to support confident decision-making across your early development programs.
FAQs
Early development decisions shape the success of every downstream stage – from formulation and manufacturing through to clinical programs. Without rigorous early screening, programs risk costly setbacks during scale-up, regulatory submission and clinical progression. Early developability assessment surfaces solubility, bioavailability and absorption constraints when they are still solvable, helping you avoid late-stage failures and optimize formulation strategy from the outset.
Our workflows are specifically designed for the constrained API availability typical of early development. Small-scale solubility screening, high-throughput characterization and prototype assessment techniques are selected to generate decision-enabling data while consuming minimal API – helping you maximize the value of limited material during the earliest stages of development.
Our high-throughput screening approach typically delivers results in approximately six weeks, allowing programs to advance without delay. Timelines may vary depending on molecule complexity, the scope of characterization and screening required, and prototype batch needs.
Our services apply a range of solid-state and drug-substance characterization techniques, including:
- Differential scanning calorimetry and thermogravimetric analysis (DSC/TGA)
- X-ray fluorescence (XRF) and X-ray powder diffraction (XRPD)
- Particle size analysis and nanomilling
- Small-scale solubility screening through viscometry, turbidity, pH, density, gravimetric and microscopy analysis
- Prototype infusion and precipitation assessment using dynamic light scattering (DLS), turbidity and mechanical or visual evaluation
These techniques support excipient and solvent selection, formulation optimization and prototype batch production for early toxicology and ADME requirements.
Prototype batches and formulation insights generated during preclinical development are designed to support entry into toxicology and ADME studies with robust, data-backed materials. Tailored solvent and excipient selection, combined with thermodynamic and kinetic solubility testing, helps optimize bioavailability and supports downstream study reliability.
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