Aseptic Fill and Finish
Bio-Concept’s aseptic manufacturing facility meets FDA (Food and Drug Administration) cGMP (current Good Manufacturing Practices) and EU (European Union) requirements for Phase 1 and 2 clinical trial product 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 aseptic fill-finish and manufacture presents.
Do You Have a Manufacture-able Formulation?
Sometimes, you have the formulation developed, compounding outlined and sterilization procedures established. All you need is your clinical trial drug to be manufactured for your clinical trial. We can do that for you.
If not, we can develop a scale-able sterile processes and formulation.
Is Your API Quantity Limited?
Early stage research often means you don’t have as much API as you would like. You need someone who will be as careful with your API (Active Pharmaceutical Ingredient) as you are. Bio-Concept ability to produce small batch sizes helps conserve your API, thus saving you money. Bio-Concept has a history of very high yields even with a low amount of API material, 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 use and can be used in the CMC (Chemistry, Manufacturing and Control) section of an IND (Investigational New Drug) Application.
What Bottles or Vials Should We Use?
Validated bottles and vials are available for our clients and can provide significant savings when their use is appropriate.
Bottle sizes covered by our validated media fills (Ophthalmics):
Vial sizes covered by our validated media fills (Parenterals)
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?