Sterile Injectable Fill and Finish
Bio-Concept’s aseptic parenteral 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 injectable 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 understands the specific challenges parenteral fill-finish and manufacture presents.
Do You Have a Manufacture-able Injectable Formulation?
Sometimes, you have the formulation developed, compounding outlined and sterilization procedures established. All you need is your parenteral drug to be manufactured 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?
Because your research is still early stage, you may not have as much API as you would like. We understand API is limited during the early stages of product development and are able to produce small batch sizes, conserving your API (and your money). 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 Vials Should We Use?
Media fill validated vials are available for our clients and can provide significant savings when their use is appropriate.
Vial sizes covered by our validated media fills:
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 parenteral process that is customized or parenteral fill finishing that conserves your limited API?