Aseptic Ophthalmic Fill and Finish
Bio-Concept’s aseptic ophthalmic manufacturing facility meets FDA (Food and Drug Administration) cGMP (current Good Manufacturing Practices) and EU (European Union) requirements for Phase 1 and 2 clinical research manufacture. The aseptic fill facility is monitored, controlled and recorded in real-time and serviced with our own WFI (Water for Injection) system. The HVAC (heating, ventilation, and air conditioning) system uses 99.99% efficiency HEPA (High-Efficiency Particulate Absorption) filters and is housed in an easily serviced mezzanine above the fill suite and below our roof, eliminating weather related malfunctions that can be prevalent in the New England region.
The flow of personnel and materials (raw material, in-process and final products and equipment) through our facility has been carefully designed, minimizing contamination and mix-ups, and follows cGMPs (current Good Manufacturing Practices).
With more than 20 years of experience in pharmaceutical research and manufacturing, Bio-Concept Laboratories has a hands-on understanding of the specific challenges ophthalmic fill-finish and manufacture presents.
Do You Have a Manufacture-able Ophthalmic Formulation?
Sometimes, your eye formulation is developed, compounding outlined and sterilization procedures established. You need ophthalmic drug manufacturing for your clinical trial. We can do that for you.
If your formulation is not ready for clinical trial production, we can help you with develop a scale-able ophthalmic formulation and manufacturing process.
Is Your API Quantity Limited?
Early stage research can mean you don’t have as much API as you would like. We understand API is limited during the early stages of product development and produce small batch sizes, conserving your API (and your budget). Bio-Concept has a history of high yields even with smaller API amounts, without compromising quality.
What Documentation Do You Provide?
Precise records are priceless. Bio-Concept creates a comprehensive batch record suitable for all clinical needs and regulatory requirements. Our batch record accurately outlines and documents all the steps needed to manufacture your product for clinical research use and can be used in the CMC (Chemistry, Manufacturing and Control) section of an IND (Investigational New Drug) Application.
What Bottles Should We Use?
We maintain media fill validations for a selection of standard bottles, including unit dose bottles. These options can provide significant savings when their use is appropriate. Learn more about our Blow-Fill-Seal alternative here.
Bottle sizes covered by our validated media fills:
- 1cc, Natural and White
- 3cc, Natural and White
- 7.5cc, Natural and White
Flexibility is important during early stage clinical trials. Accommodating your needs, we work with many custom configurations and develop validations for custom requirements.
Do you need a customized ophthalmic process or fill-finishing that conserves your limited API?