Contract Manufacturing:

Customized Development Programs From Conception through FDA Approval

Our expertise with environmental control makes Mycoscience a logical choice for cleanroom contract manufacturing. We specialize in environmentally controlled, low volume, clinical production of diagnostics, pharmaceuticals and devices. We offer a variety of cleanroom options from Class 100 to Class 100,000. Our facilities include a Class 100 syringe filling suite, with the capacity to fill thousands of syringes per hour.

Need help with product development? We have designed, developed and obtained FDA approval for a wide variety of medical devices and diagnostic products, from HP Fast™ (our rapid test for Heliobacter pylori bacteria) to SPOT™ (our diagnostic marker for colon cancer). Whatever your requirements, our efficiency and expertise will enable you to achieve timely, cost-effective manufacturing solutions.

• Research and Development
• Batching and Filling Services
• Class 100 - Class 100,000 Manufacturing Areas
• Prototypes and Clinical Samples
• Packaging and Sterilization 
• Aseptic Filling of Syringes and Vials
• Air-Overpressure Steam Sterilization
  
• Dedicated Filling Suites