Welcome to J-STAR Research, Inc.

Analytical R&D and Quality Control

Our Analytical Research team provides all of the analytical needs for process development, GLP studies and GMP campaigns. In general, our service includes, but is not limited to, method development, method verification / validation, reference standard certification, release testing, and impurity separation and identification.

• HPLC / GC method development for challenging separations including chiral separations
• Method development and testing using LC/MS LC/ELSD GC/FID GC/MS NMR TGA KF DSC FT-IR Polarimeter
• Method transfer / validation
• Reference standard certification
• Separation and Characterization of impurities and degradants
• Raw material
• Intermediate and API release testing
• Stability studies: stability indicating method development and stability sample testing

Catalyst Screening & Enabling Technology

Our services in catalysis reaction development are differentiated through our integrated approach in the overall process development. We develop efficient catalytic reactions by utilizing the newest tools together with verified experimental high throughput techniques, scientific and industrial knowledge.

• Custom development planning (early development vs. manufacturing process or fit for purpose vs. optimized for efficiency).
• Catalyst screening based on published scientific knowledge and more than 20 years of industrial experience in catalysis research.
• Increased catalyst performance through mechanistic understanding.
• Process optimization using high throughput DoE experimentation.
• Process stability with Kinetic-DoE
• Scale-up under best engineering consideration and representative scalable procedures.
• Efficient technology transfer

Center for Pharma Crystallization

As one of the oldest unit operations known to mankind, crystallization today is a leading method for efficient isolation of drug substances with high purity and desired solid state characteristics, to ensure efficacy and safety of drug products.

• Crystallization Process Development
• Particle Engineering & Co-Processing
• Solid Form Screen & Studies
• Pre-Formulation Evaluations

Drug Product Development

Seamlessly and in parallel with our crystallization experts develop rugged processes and formulations that follow rigorous QbD procedures, fundamentals of material science and fit-for-purpose enabling technologies.

• Solid state and powder characterization
• Pre-formulation and pre-clinical packages
• Phase 1 formulation development and supply
• Formulation development for on-site compounding clinical CRO
• Phase 2 and 3 formulation and process development
• Spray drying technology platform
• HME technology platform
• Co-processing technology platform
• Co-processing to enable facility light high potency API handling

High Potency API (HPAPI) Handling & Development

Recent trends in drug development have seen a surge in demand for high potency production capabilities, a demand J-STAR is perfectly positioned to meet. Our state-of-the-art facility can help meet the needs of your high potency development programs as our subject matter experts ensure that we will handle your API programs with the highest level of care and safety to ensure success.

• Extract-Walker Barrier Isolators: 2
• 16 HPAPI Linear Glover Box Feet: 16
• OEL Target (ng/m3): 10

GMP API Manufacturing

Renowned in the industry for the flexibility and innovation of our processes, J-STAR can scale our chemistries to handle quantities from milligram to multi-kilos.

For volume exceeding the capacity of our NJ facilities, we can also leverage our parent company (Porton) to support larger scales spanning to commercial capacity.

• Manufacture intermediates and impurities
• Reference Standards
• Non-GMP APIs
• Raw Materials