From molecule
to mold.
Fourteen days.
Active
Project Grid
This Month
To Delivery
Every project,
every gate.
From standard tablet geometry to a six-component auto-injector. Each case study is the exact sequence that happened on this floor.
Helix needed 50 dosage-form variants of a 1000mg extended-release metformin tablet across three geometric profiles — oval, biconvex round, and caplet — for a Phase II bioequivalence study. Submission deadline was 16 days from brief.
Hydroxypropyl methylcellulose matrix required precision layering at ±2μm tolerance. Standard tooling was unavailable; custom punch geometry had to be machined in-house within 48 hours of brief approval.
Three-geometry CAD models with cross-section tolerances defined.
50 variants delivered on Day 14. All three geometries passed dissolution testing first pass. Zero QC failures. Regulatory package submitted Day 16.
Kinetic needed a non-functional ergonomic prototype of a single-use auto-injector for a 40mg/0.4mL adalimumab biosimilar. The device had to survive a 510(k) human factors submission review including a 180-day shelf-life simulated aging test.
Six-component assembly: outer shell, needle shield, plunger, spring, window panel, and labeling substrate. Each component required separate tooling. Spring force simulation had to match ±0.5N of the reference-listed device.
Six-component exploded assembly with tolerances for human factors.
All six tooling sets completed by Day 8. First full assembly on Day 11. Human factors study passed with 97% first-attempt activation rate. 510(k) submission accepted without major deficiency letter.
Apex was 6 weeks from a commercial launch when their incumbent CMO failed a critical dimensional audit on the inhaler mouthpiece. They needed a fully functional DPI prototype with blister pack cartridge tooling that could pass an FDA Device Listing inspection.
Mouthpiece airflow geometry was proprietary — reverse-engineered from the existing device using CT scanning. Blister foil tooling required 96-cavity precision at 0.1mm registration tolerance. Emergency 72-hour sprint for first prototype.
CT reconstruction of reference device — mouthpiece geometry extracted.
First mouthpiece prototype delivered in 68 hours. Blister tooling completed Day 7. Full functional DPI system with 10-blister cartridge cleared FDA Device Listing inspection on Day 14. Launch timeline preserved.