Phase I & FTIM
Metrics Contract Services supports a wide range of clients for Phase I or First-Time-In-Man (FTIM) programs.
From the virtual or small biopharmaceutical company looking for a CDMO partner to help guide them through the early development path to their first clinical study; to the medium sized pharmaceutical organization wanting a partner to collaborate on development success; to the large pharmaceutical company seeking a new path to early clinical study product manufacturing so they can stay competitive in today’s marketplace.
Metrics Contract Services takes several different approaches to FTIM studies depending on the desired end result:
Active Pharmaceutical Ingredient (API)-in-Capsules – using our Xcelodose 600 encapsulator, we can fill API directly into a capsule with high precision and accuracy over a dosage range of 1 mg to 250 mg is typical and in our experience.
Blend and fill – based on the physical and chemical properties of the new chemical entity, Metrics has the ability to develop a basic blend of ingredients to help with either manual or semi-automated capsule filling.
Tablets – Similar to the blend and fill approach, a tablet formulation might be suggested as the most applicable approach to develop a Phase I dosage form.
Extensive Analytical Support
All the product development and clinical trial materials manufacturing are supported by an Analytical Laboratories Services group made up of approximately 100 chemists trained to deliver:
- Method development or optimization.
- We can develop new analytical methods
- Optimize or enhance methods provided by the client or the client’s API provider
- Phase appropriate Method Validation.
- Validation protocols developed according to FDA guidelines
- Reviewed and approved by our clients.
- Providing a method that delivers appropriate data to support early clinical phase production.
- Clinical Trial Material Product Release Testing
- Stability Study support testing services
- New Stability Storage Facility with over 17,000 sq-ft of shelf space.
- All ICH storage conditions available
Metrics engages with clients on FTIM projects with your critical milestones in mind:
- Typical project timeline from receipt of API to shipment of clinical trial materials is 3 to 5 months*
- A Project Manager or Project Leader is assigned to assure both companies meet the project goals mutually agreed upon
- You are encouraged to engage technically with our development and analytical laboratories staff to fully understand the scientific aspects of the work
Our campus in Greenville, North Carolina can is designed to facilitate all clinical phase production through commercial manufacturing. For Phase I, First-Time-in-Man studies we offer:
- Clinical Trial Material batch sizes from benchtop scale to pilot scale and beyond. This flexibility allows Metrics to react to the demand of your study size.
- High Potent Compound Handling:
- Hard-wall Isolation technology for batch sizes up to 8kg
- Xcelodose 600S located in our high potent processing area
- Bottle packaging capabilities – manual or automated packaging lines.
*Some projects could take longer depending on the development complexity.