Sterility testing results in hours, not weeks.
Sapho Bio's RNA-based platform detects living bacteria and fungi in approximately 20 hours, replacing the 14-day standard. Works with your existing qPCR equipment.
Benefits
The standard hasn't changed. Until now.
Every pharmaceutical product must pass a sterility test before it can be released. For decades, the industry has relied on the same method.
Traditional Method
14 days
Incubate samples for 14 days
Manual visual inspection for turbidity
Drug batches held in quarantine
Capital locked, shelf life consumed
Method introduced decades ago, not designed for modern therapies
Sapho Bio
20 hours
RNA-based detection of living organisms
Objective molecular results, not visual inspection
Faster release decisions, less quarantine time
Capital freed, shelf life preserved
Works with existing qPCR machines in your lab
Traditional Method
Sapho Bio
WHY NOW
Precision medicines are redefining what "fast enough" means.
Cell therapies, patient-specific products, and biologics with short beyond-use dates cannot afford a 14-day wait. Every hour in quarantine is an hour of usable product life lost — and for some therapies, that window is already narrow.
01
Short Product Lifespans
Precision therapies often have lifespans measured in days. Every delay reduces the time available for treatment.
02
Idle Inventory
While testing is ongoing, products remain in quarantine. This slows operations and delays time to market.
03
Growing Demand
The precision medicine market is expanding quickly, but testing infrastructure has not kept pace.
04
Legacy Bottleneck
Traditional sterility testing was designed for stable drugs, not time-sensitive therapies.
How it works
Four steps. One day.
Our lab service model means you can start testing immediately, no capital equipment purchase, no lengthy onboarding.
Traditional sterility tests rely on visible growth. It works, but it’s slow.
TECHNOLOGY
We detect what's alive at the molecular level.
Pipeline
A platform, not just a test.
Rapid sterility testing is our first product. Sapho Bio is building a broader rapid microbiology release platform with multiple programs in active development.
Commercialized
Rapid Sterility Testing
RNA-based detection delivering results in ~20 hours. Available through our lab service model.
In Development
Sterility Testing Kit
Extending the platform to on-prem GMP sterility testing applications
Research
Muscle-Sparing Biologic
A monoclonal antibody fusion protein designed to preserve muscle mass, currently in development.
How it works
