Baxter is seeking simplified methods for detecting endotoxin contamination in aqueous solutions
Background
The production of sterile, injectable fluids is the foundation of several core areas of our business. For example, saline solutions are critical to our hospital products business and dialysis solutions are used for continuous renal replacement therapy, hemodialysis, and peritoneal dialysis.
Today, our aqueous solutions are produced and terminally sterilized in large manufacturing facilities. At Baxter, we envision a future where solutions are produced at smaller scale and closer to the point-of-use. To realize this vision, we must ensure that the final solutions delivered to patients are free from endotoxins.
Bacterial endotoxins are structural parts of gram-negative bacteria cell walls. When released during cell lysis, endotoxins can create a fever-inducing response in humans. All major manufacturing processes prescribe bacterial endotoxin testing (BET) and/or pyrogen testing to ensure pharmaceutical products are safe for use. However, there are challenges with these methods that prevent their use in small-scale manufacturing operations where the end user is less skilled and may even be the patient. These methods are also expensive, labor intensive, and not conducive to point-of-use production.
What we’re looking for
We are seeking simplified methods for detecting endotoxin contamination in aqueous solutions that can be performed by untrained operators, such as patients. The project should result in a demonstrated proof-of-concept or prototype.
Our must-have requirements are:
- Total projected cost per test < $20
- Does not require reagents to perform measurement
- Sensitivity – Able to detect endotoxin levels in the fluid > 0.25 EU/ ml
- Test is no more complex than existing home medical tests (e.g. pregnancy, COVID)
Our preferred requirements are:
- Total projected cost per test < $1.00
- Does not require user interaction (e.g. can be fully integrated into the manufacturing equipment or a medical device).
- Sensitivity – Able to detect endotoxin levels > 0.03 EU/ ml
- Enables continuous measurements
What's our of scope:
- Technologies/methods requiring advanced training or prior laboratory experience
- Technologies/methods requiring significant capital equipment
Award details and award period: Award Amount: $150,000 to $300,000 depending on proposal