Sterile Clinical Manufacturing
The manufacturing process stage is similar to creating a recipe. We determine what ingredients should go into the formulation, at what intervals and under what conditions. It is another instance where our experience proves to be invaluable.
Each customer has different needs and different requirements. That's why Bio-Concept's Clinical Manufacturing Program offers so much flexibility. We will work with almost any customer configuration and support a variety of testing procedures. We will make sure your product is ready for clinical trial and manufacture.
Batch Documentation
The master batch record precisely outlines all the steps needed to manufacture your product for clinical use. As part of our Clinical Manufacturing Program, Bio-Concept creates a comprehensive master batch record suitable for all clinical needs and FDA approval.
Clinical labeling
In an effort to further reduce your time to clinical trial, Bio-Concept can label your product to avoid delays in using an outside company.
Configurations
Bio-Concept has the flexibility to work with many different types of configurations. These include:
Aseptic Liquid Fills
- Glass vials
- Plastic bottles
- Volumes from 0.5 mL to 30 mL
- Batch size of 2,000 units
Sterilization Processes
- Filtration
- Bulk solution autoclave
- Split-phase