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Formulation and Manufacturing Technologies
The platforms determining whether a difficult molecule becomes a product, and whether it can still be made at launch scale.
The formulation route is decided early
By the time a program formally enters drug product development, the formulation route has usually been narrowed, often by a solubility result from a preclinical study. Reversing it later means new stability data, comparability work and a bridging study.
The screening that selects between these platforms is best done while the API route is still being optimized, when the formulation route can still be changed.
Choosing between the technologies
Most poorly soluble molecules could be formulated more than one way. Spray-dried dispersion, hot melt extrusion, a lipid system or a nano suspension will each work for some compounds and fail for others, and the failure often appears months into development.
We screen the candidates in parallel. More than 360 molecules a year go through bioavailability enhancement at WuXi STA, 17 of them late-phase or commercial products, and the recommendation for a new molecule draws on those outcomes.
Spray-dried dispersion
More than 460 spray-dried dispersion batches a year, across five commercial projects. SDD is the most common route for a poorly soluble molecule, and the platform covers every scale from screening to commercial.
Screening runs on Buchi B90 and B290 units, ProCepT, Yamato and SD Micro. Scale-up and commercial manufacture run on GEA PSD-1, PSD-3 and PSD-4 dryers. A formulation developed at milligram scale moves through that range inside one organization.
A second PSD-4 comes online at Couvet in Q4 2026, putting commercial spray drying in Europe.
Hot melt extrusion
For molecules where a solvent-based process is unsuitable — thermally stable compounds, high drug loading, or where residual solvent must be avoided. Available at Wuxi City alongside the other enabling technologies, so a molecule can be screened against both HME and SDD before either is committed.
Lipid and nano formulation
Lipid-based formulations, nano suspensions and lipid nanoparticles. Nano suspension suits compounds where dissolution rate rather than solubility is the limit; lipid systems suit compounds that need a solubilized state through the gut.
Lipid nanoparticles run on the parenteral platform as well, including for mRNA and DNA payloads — the same formulation and fill-finish capability, applied to a different modality.
Oral solids
Tablets, capsules, powders, granules and bottled liquid. More than 1,000 drugs supported from preclinical to commercial, 3,200+ batches delivered a year, and annual capacity above 10 billion doses.
Packaging and labeling sit in the same operation: bottle, blister and sachet, with open-label and double-blind labeling for clinical supply.
Sterile fill-finish
Five aseptic filling lines and more than 100 million units of annual capacity. Filling into vials, prefilled syringes, cartridges and LDPE ampoules, with sterile filtration, moist-heat sterilization or irradiation depending on the product.
Dosage forms cover solution, lyophilized powder, suspension and emulsion, and the advanced formulations: liposomes, lipid nanoparticles and nanoparticles. Sterile fill-finish will be added at Middletown, Delaware in Q4 2027.
High-potency handling on every platform
Every platform above is available for high-potency compounds at an occupational exposure limit of 10 ng/m³, at 1.1 billion doses a year for oral solids and 25 million vials for injectables.
Parallel screening
A poorly soluble molecule can usually be formulated more than one way, and a wrong choice often only shows months later. Screening the candidates in parallel establishes which will hold before the route is committed.
The comparison draws on a platform that produces more than 460 spray-dried dispersion batches a year.