Solutions
Autonomy mapped to your product and your role.
The economics of sterile fill-finish differ by molecule and by mandate. Whether you make biologics or vaccines, run a CDMO, or own quality, operations, or engineering, Sterira meets a specific, measurable pain.
By product
The molecule sets the stakes.
Biologics & mAbs
Shear-sensitive, high-value fills where overfill and foaming scrap units worth thousands. Precision filling and false-reject reduction pay for themselves fast.
Vaccines
Lyophilized products where cycle time gates site throughput. Adaptive lyo control recovers capacity without touching cake quality.
Sterile injectables
High-volume aseptic lines where intervention deviations and release delays dominate cost. Robotics and review-by-exception move the needle.
Cell & gene
Ultra-high-value, low-volume batches where a single lost unit is catastrophic. Full traceability and zero-touch handling protect every dose.
Ophthalmics
Particulate-critical products where inspection precision is everything. Learned classification catches true defects without over-rejecting.
Diluents & combos
Complex fill sequences where consistency across components matters. One system unifies the whole line.
By role
Your mandate, your metric.
Fewer deviations, faster release
Live contamination risk, exception-based review, and a Part 11 trail that stands up to inspection.
Yield and throughput
False-reject reduction and lyo cycle recovery turn straight into output on your most constrained assets.
Faster, safer process change
The digital twin de-risks scale-up and tech transfer, cutting engineering batches.
Capacity without capex
Recover hidden capacity from existing lines instead of building new ones.
For CDMOs
Win programs on cost, quality, and speed.
CDMOs compete on right-first-time, release velocity, and price. Sterira's multi-tenant deployment lets you run autonomous fill-finish across client programs with strict data separation, a differentiator you can put in a proposal.
See enterprise pricing →Outcomes
Land on one metric. Expand from there.
- 01
Pick the pain
Choose the single workflow with the clearest hard-dollar cost on your line.
- 02
Pilot it
Deploy one agent, measured against a reject, deviation, or yield metric.
- 03
Prove the number
Validate the result with your quality team on real batches.
- 04
Expand the suite
Roll agent by agent, line by line, site by site.
Why now
The pressures are converging.
A biologics boom is straining fill-finish capacity, Annex 1 is raising the compliance bar, and skilled aseptic operators are scarce. Autonomy is how leading sites absorb all three at once.
- Demand outpacing sterile capacity.
- Annex 1 raising contamination-control expectations.
- Aseptic talent increasingly hard to hire.
Solution map
Which agent for which problem.
Scrapping good units
Inspect & Release: cut false rejects.
Overfill on biologics
Fill & Dose: micro-tolerance control.
Lyo is the bottleneck
Lyophilization: recover cycle time.
Intervention deviations
Robotic Handling: remove people.
Late sterility signals
Contamination Control: live risk.
Slow release
Batch Review: review by exception.
"We started with the one line bleeding money on false rejects. Once that number moved, expanding to the rest of the suite was an easy conversation."
Sterile injectables site
FAQ
Common questions.
No. Most customers start with one agent on one line, tied to a single hard metric, and expand from there.
The one attached to your biggest hard-dollar problem, usually false rejects, lyo throughput, or intervention deviations. We help you pick during scoping.
Yes. The Line tier deploys a single agent, so the entry point scales to a single high-ROI workflow. See pricing.
Find the metric worth moving first.
Tell us your product and pain, and we'll map the fastest ROI.