Phase II & III

Scaling up your drug product can be difficult and finding the right solution to ensure commercial viability, high quality and safe processes takes relevant expertise. Here at Metrics Contract Services, we blend scientific understanding and creative thinking,
to offer innovative solutions every step. We are dedicated to your project’s success and our goal is to help customers progress their complex compounds throughout its clinical journey with confidence.

Whether we are scaling up a Phase 1 program or supporting a product’s transfer to Metrics, our scientists develop products at the Phase II and III stage with Quality by Design (QbD) and commercialization in mind. Our experiments identify the parameters and the Design of Experiments (DoE) confirm the ranges for formulation and the manufacturing process.

Formulation Development

Metrics scientists may suggest an excipient compatibility study to determine which inactive ingredients are best suited to meet the dosage form requirements to support a Phase II (or III) project. The relative amounts of inactive ingredients in relation to the API will be evaluated to identify a suitable drug product formulation.

The inactive ingredients will be selected based on the properties desired for the drug product, either as immediate, modified or controlled release dosage forms.

Process Development

Our expert scientists and experienced operators will recommend studies to determine which process is most suitable for the drug product.

We evaluate the use of techniques that include:

  • High shear wet granulation
  • Dry granulation
  • Milling and micronizing
  • Fluid bed coating and drying (extrusion and high shear)
  • Wurster granulation and coating
  • Tablet and capsule film coating
  • Pellet (bead) layering and coating

The selected manufacturing process will be evaluated using a Design of Experiment or an experimental batch. Proactive problem solvers first and foremost, our team will troubleshoot and optimize your process efficiently.

Batch Size and Scale-Up

Throughout Phase II and Phase III, Metrics considers your scale-up and commercialization requirements. We offer various sized equipment to accommodate each phase and enable efficient scale-up which conform to SUPAC requirements. Clinical Trial Material batch sizes from 100g to 450kg.

All clinical trial material manufacturing is supported by a large analytical laboratory group within our single-campus state-of-the-art facility.

At Metrics, we promise a collaborative partnership offering guidance throughout your program.

Scale Up

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