Phase 2 & 3 Drug Product Development and Troubleshooting

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 and Process Development

Formulation Development - Starting from an NCE

Provide Phase Appropriate Formulation through Decision Tree and Target Product Profile

Whether it is Phase I or II or III formulation design, we are guided by formulation decisions based on fundamental material properties, supported by Quality Target Product Profile (QTPP) requirements 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 Services

J-Star Research’s specialists can also compile high-quality drug product development reports for Chemistry, Manufacturing, and Controls (CMC) section to support regulatory filings for Investigational New Drug (IND), New Drug Application (NDA), and/or Abbreviated New Drug Application (ANDA). Documents are provided in a format designed to facilitate CMC responses to global regulatory applications.

Troubleshooting

Oral solid dosage forms (e.g., tablets, capsules, granules, etc.) dominate the global pharmaceutical market due to their convenience of storage, ease of administration, consumer safety and affordability. Unfortunately, technical issues related to formulation, processing, and manufacturing equipment settings can hinder the oral solid dosage form development stages, issues related to batch size and cycle time dependence can occur in late clinical or commercial scales, and defective samples over the acceptable quality limit (AQL) can cause entire manufacturing batch failures.

Depending on the specific issue, troubleshooting can lead to reformulation, redevelopment of processing method, or parameter adjustment of processing equipment – all of which can require vast amounts time, materials, and funds to resolve.

Scientists from J-Star Drug Product Development possess extensive expertise in oral solid dosage form troubleshooting. We can quickly analyze your problems and provide practical solutions to overcome issues from formulation to process - saving you time, money and headaches.

Using advanced tools to investigate problems including but not limited to:

Process Equipment

Characterization Instruments