Pace Analytical services

Pace® scientists and project managers are committed to the success of your project. You will have access to experts who can offer advice and guidance based on similar work performed in our gene therapy labs. Our project managers also understand your need for us to be flexible in project scope and timing.

In early-phase gene therapy development, we work with you to determine the most reliable analytical methods to provide the data needed to guide effective development decisions. Next, we deliver a robust assessment of the physicochemical and biophysical characteristics of the therapeutic molecule.

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.

We follow current Good Manufacturing Practices (cGMP) in our clinical supplies manufacturing, packaging, and labeling services for domestic and international studies. Entrust your tablets, capsules, and powders to our experts so your clinical trials can proceed with ease. Pace® is open to supporting unique dosage form and manufacturing processes. Our manufacturing facilities meet FDA, cGMP, and EU requirements for Phase I and II clinical supplies, and are licensed with the Drug Enforcement Agency to manufacture and test controlled substances. We designed our facilities to handle a variety of manufacturing challenges such as potent compounds, light sensitive compounds, and organic solvent processing.