WuXi AppTec details how formulation shapes next-generation drug development

WuXi AppTec says formulation decisions can determine whether complex molecules become usable medicines, affecting solubility, stability, delivery, and clinical supply. The company outlined how it pairs preformulation, delivery screening, and scale-up across small molecules, oligonucleotides, and targeted protein degraders.

Why it matters: - Formulation can determine whether a drug candidate dissolves, stays stable, and reaches the body in a usable form. - For complex molecules, poor absorption or weak delivery can block development even when the molecule hits its intended target. - The same formulation strategy can also shape whether a program can move from preclinical work into clinical supply on time.

What happened: - WuXi AppTec described how it connects formulation, chemistry, and manufacturing from early studies through late-stage supply. - The company highlighted preformulation work, delivery screening, parallel chemistry and formulation development, and scale-up for clinical production. - WuXi STA’s services cover small molecules, targeted protein degraders, peptides, and oligonucleotides.

The details: - Preformulation studies examine solubility, stability, and compatibility with excipients. - Those studies help determine which physical form and formulation approach fit a candidate before preclinical testing. - The results support formulation choices for pharmacokinetic, pharmacodynamic, and toxicology studies. - For poorly water-soluble compounds, WuXi AppTec uses spray dried dispersion, hot melt extrusion, nanosuspensions, and lipid formulations. - Spray dried dispersion places the drug in an amorphous form within a polymer matrix to improve dissolution. - In one project, a molecule with a molecular weight above 1,000 daltons had poor water solubility and oral absorption below 1%. - After delivery screening and spray-drying optimization, bioavailability rose above 30%. - For oligonucleotides, WuXi STA’s lipid nanoparticle platform combines formulation and process development with drug substance manufacturing and analytical support. - The platform also includes synthesis and manufacturing of oligonucleotides and functional lipids. - Lipid nanoparticles protect against serum nucleases and help deliver material to specific cells or tissues. - In a targeted protein degrader program, process chemists, biocatalysis specialists, crystallization scientists, and formulation scientists worked in parallel to prepare first-in-human material. - The original synthesis used 24 steps and had a 0.3% yield. - The team shortened the route to 16 steps and replaced palladium catalysts with biocatalysts in two steps. - Spray dried dispersion optimization increased tablet oral bioavailability by about 30 times. - WuXi STA delivered the study material within 12 months, two months ahead of schedule. - For clinical supply, WuXi AppTec uses spray drying equipment that spans laboratory development and production. - The platform supports tablets, capsules, powders, and granules. - In a Phase III supply project, WuXi STA moved a spray drying process from the PSD-1 system to the larger PSD-3 system in three months. - The company delivered 1,400 kilograms of dispersion intermediate for that program.

Between the lines: - The company is positioning formulation as a core development lever, not a late-stage packaging step. - The examples point to a broader theme: formulation choices can affect both biological performance and manufacturing speed. - Parallel development appears aimed at reducing rework between chemistry, delivery, and scale-up teams.

What's next: - WuXi AppTec says early formulation data guide the next development step, from candidate selection to delivery approach and then to clinical production. - The company expects its integrated development and manufacturing services to continue carrying formulations from lab work into late-stage supply. - The late-stage scale-up example suggests the platform is intended to support larger clinical programs as they advance.