With more than 20 years of experience in pharmaceutical research and manufacturing, we understand the specific challenges aseptic fill-finish and manufacturing presents. Our facility is carefully designed with the flow of personnel and materials in mind, which follows current Good Manufacturing Practices (cGMP) guidelines and minimizes contamination or mix-ups.
Flexibility is important during early-stage clinical trials. We work with many custom configurations and develop validations for custom requirements that accommodate your needs.
Formulation to Clinical Trial Materials Manufacturing
Once you have developed the formulation, have the compounding process outlined, and established sterilization procedures, our team is here to manufacture your clinical trial drug product. We can also develop sterile, scalable processes and formulations.
Our aseptic fill-finish manufacturing facility meets FDA, cGMP, and EU requirements for phase I and II clinical trial products. The sterile fill facility is monitored, controlled and recorded in real-time and serviced with our own Water for Injection (WFI) system.
The HVAC system uses 99.99% efficiency HEPA (High-Efficiency Particulate Air) filters. It is housed in an easily serviced mezzanine above the fill suite and below our roof, eliminating weather-related malfunctions.
Small Batch API
Early-stage research often means you do not have as much active pharmaceutical ingredient (API) as you would like. Our solutions and ability to produce small batch sizes helps conserve your API to save you time and money. Pace® has a history of very high yields without compromising quality, even with a low amount of API material.
Batch Records for IND Application
We create 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, which can be used in the Chemistry, Manufacturing and Control (CMC) section of an Investigational New Drug (IND) Application.
Bottles & Vial Selection
Validated bottles and vials are available for our clients and can provide significant savings when their use is appropriate.
Ophthalmic bottle sizes covered by our validated media fills include 1cc, 3cc, and 7.5cc.
Parenteral vial sizes covered by our validated media fills include 2mL, 5mL, 10mL, and 20mL.