Metrics Contract Services Continues Strong Focus on First-Time-In-Man and Phase I Services
For over 20 years, Metrics’ pharmaceutical development services have been growing and offering our clients expanding capacities, capabilities, and manufacturing processes for small molecule oral solid dosage forms. Over the past two years, we have been excited to share our progression into commercial manufacturing with the completion of our Greenville, NC campus expansion.
What we want to do today is remind our clients and the industry that we have not lost our focus on where it all began. Metrics continues to invest in equipment and resources to support a healthy foundation of business in the First-time-in-Man/Phase I space.
We continue to support virtual or small biopharmaceutical companies looking for a CDMO partner to help guide them through the early development path to their first clinical study; or the medium sized pharmaceutical organization wanting a partner to collaborate on maximizing development data from every batch; and even the large pharmaceutical company seeking a new path for early clinical manufacturing so they can stay competitive in today’s marketplace.
Depending upon the client’s desired end result, Metrics can take several different approaches to FTIM studies, including:
- API in capsules. Using an Xcelodose 600 encapsulator, Metrics scientists can fill API directly into a capsule with high precision and accuracy over a wide range of dosages.
- Blend and fill. Based on the physical and chemical properties of the new chemical entity, Metrics scientists skillfully develop a basic blend of ingredients to help with either manual or semi-automated capsule filling.
- Our Scientists have experience with a variety of tablet formulations and can help advise clients if this is the best approach for their Phase I dosage form.
Metrics supports all product development and clinical manufacturing with 100-plus analytical chemists who are trained to deliver:
- Phase-appropriate method development, optimization, and validation that meet FDA guidelines
- Drug substance and drug product release testing for Clinical Trial Material
- Stability studies support testing services across all ICH conditions as well as specialized conditions
We assign a project leader to every FTIM / Phase I project to ensure that your goals are met. Clients are always free to engage directly with the technical staff in our development and analytical laboratories to fully understand the scientific aspects of work being performed.
If you’d like to learn more about Metrics’ FTIM / Phase I clinical trial materials knowledge or experience, contact a member of our Business Development Team.