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Phase II & III

Metrics engages with clients at all phases of pharmaceutical development, from the clinical stage through commercial manufacturing.

Whether we are working with a client that started with us in Phase I, or a company that is transferring their product to Metrics, it is at this phase that we begin thinking about the success of a product making it to the market.

Our scientists develop products at this stage with Quality by Design (QbD) in mind. The experiments we conduct help identify the parameters and the Design of Experiments (DoE) confirms the ranges for both the formulation and the manufacturing process.

Formulation Development

  • Metrics scientists may suggest the initiation of a Phase II (or III) project with an excipient compatibility study to determine which inactive ingredients are best suited to meet the dosage form requirements.
  • The relative amounts of inactive ingredients in relation to the API will be evaluated to identify the suitable drug product formulation.
  • The inactive ingredients will be selected based on the properties desired for the drug product (immediate, modified, or controlled release dosage forms).

Process Development

  • Our scientists will initiate experiments and studies to determine which process is most suitable for the drug product and manufacturability. (See the list below for the types of manufacturing processes available at Metrics.)
  • We would evaluate the use of techniques that include
    • Blending and compression
    • Dry Granulation (roller compaction)
    • Wet Granulation (High Shear)
    • Fluid Bed Processing – drying, granulation, coating
    • Tablet compression (including mini-tablets)
    • Tablet coating (Perforated Pan)
    • Encapsulation (blends, beads, mini-tablets, or multi-component)
  • The selected manufacturing process will be evaluated using a Design of Experiment or producing an experimental batch

Batch Size and Scale-Up

  • Throughout Phase II and Phase III Metrics would be considerate of the necessary batch sizes and any potential scale-up requirements a drug product would require as it progresses toward commercialization.
  • We offer various sized pieces of equipment to accommodate the requirements of these clinical phases.
  • Our equipment trains enable easy scale-up and can conform to SUPAC requirements.
  • Clinical Trial Material batch sizes from 100 grams to 450 kilograms.

 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:
    • Develop new analytical methods as needed
    • 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

Customer Support

Metrics engages with our clients on these projects with their critical milestones in mind:

  • A Project Manager or Project Leader is assigned to assure both companies meet the project goals that have been mutually agreed upon.
  • Clients are encouraged to engage technically with our development and analytical laboratories staff to understand the scientific aspects of the work.

Facilities

Our campus in Greenville, NC is designed to facilitate all clinical phase production through commercial manufacturing. For Phase II and III studies:

  • 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
  • Bottle packaging capabilities – manual or automated packaging lines