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 forward your formulation to our parent company (Porton Pharma Solutions Ltd.) 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 Quality Target Product Profile (QTPP) 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

Regulatory Support

J-Star Research experienced specialists can compile high-quality drug product development report for CMC section in support of regulatory flings (IND, NDA, and/or ANDA); and can provide documents in the desired format to facilitate any response to CMC questions raised for the global regulatory applications.

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


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

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J-STAR Research helps pharmaceutical small molecule R&D programs succeed in all phases of development.