J-STAR Research, Inc.

Overview

J-STAR Research, Inc., founded in 1996 and a subsidiary of Porton Pharma Solutions Ltd., is a contract process R&D and cGMP manufacturing organization serving pharmaceutical and biotechnology clients across all phases of small molecule drug development.

Core Capabilities

Drug Substance (DS) Development & Manufacturing

• Process R&D: Synthetic route design, high-throughput experimentation (HTE), high-pressure chemistry, continuous flow chemistry, design of experiments (DoE), and process analytic technologies (PAT) with reaction kinetics support.
• High-Potent & Controlled Substances: DEA Schedule II–V controlled substance manufacturing, potent and HPAPI compound development, and ADC payload and linker synthesis.
• Crystallization R&D: Solid form screening and selection, crystallization process development, and single crystal structure elucidation.

Drug Product (DP) Development & Manufacturing

• Pre-formulation evaluations, Phase 1 clinical supply and support services, and Phase 2 & 3 drug product development.

Analytical R&D & Quality Control

• ICH stability studies, genotoxic impurity assessment, impurity isolation and structural elucidation, reference standard certification, method validation and verification, method development with forced degradation studies.

Technology Solutions

• Particle engineering and co-processing, computational chemistry and data science for molecular property prediction, and catalysis and enabling technology platforms.

Regulatory & Quality

The organization operates under cGMP standards and supports clients from early development through commercial manufacturing phases.