Phase 2 & 3 Drug Product Development and Trouble Shooting

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Phase 2 & 3 Drug Product development and trouble shooting

Scale from Small-Batch Lab to Multi-Kilo GMP

With the completion of phase 1 we can develop late-phase formulations in our R&D lab, but what if you need to quickly scale to GMP manufacturing?

At J-STAR Research, we have the ability to quickly pass your formulation to our parent company (Porton) for large-scale, multi-kilo GMP, but if you prefer stay local, we also have many national partners with robust commercial capacity we collaborate with on a regular basis.

Formulation Development

Provide Phase Appropriate Formulation through Decision Tree and Target Product Profile

Whether it is Phase 1 or 2 or 3 formulation design, we are guided by formulation decisions based on fundamental material properties, supported by appropriate use of QTPP (Quality Target Profile) tailored for the appropriate clinical phase.

Phase Appropriate QbD Based Formulation Development

We understand the requirements of each phase of development. While timeline and maximum exposure are important in Phase 1, scale up and appropriate process design are increasingly emphasized as we move forward to Phases 2 and 3.

Formulation and formulation process design are based on risk assessment appropriate DS material properties that are the Critical Quality Attributes.

Process Development

  • Provide Phase Appropriate Formulation through Decision Tree and Target Product Profile
  • Phase Appropriate QbD (Quality by Design) Based Formulation Development
  • Formulation Risk Assessment Based on Material Properties
  • Phase Appropriate Equipment Selection
  • PAT (Process Analytical Tool) Selection and iImplementation
  • Statistical and/or Mechanistic Model for Unit Operations
  • Phase Appropriate QbD for Design Space and/or Process Operating Range Determination
  • CPP (Critical Process Parameter) identification
  • Risk Assessment
  • DOE (Design of Experiment) and/or model assisted DOE

Trouble Shooting - Formulation

Using Advanced tools to investigate problems related to formulations including but not limited to:

  • BE (Bioequivalence)
  • Excipient Compatibility
  • Reverse Engineering
  • Sticking Picking and Powder Flow Properties
  • Stability

Trouble Shooting - Process

  • Blend and Content Uniformity
  • PAT Development
  • Powder Flow Improvements
  • Knowledge Based Scale Up
  • Reverse Engineering
  • Improve Equipment Performance
  • Equipment Selection
  • Continuous Processing Feasibility Evaluation Through Material Properties Characterization and Unit Operation Feasibility Studies

Process Equipment

Characterization Instruments