Welcome to J-STAR Research, Inc.
Our mission is to help pharmaceutical small molecule R&D programs succeed in all phases of development.
Contract Research & Development Services
J-STAR Research provides a wide range of small molecule chemistry capabilities and technologies, including:
Process Chemistry Research & Development
The focus of the company is on helping the pharmaceutical industry to develop scalable, robust and economically feasible syntheses supporting small molecule pre-clinical development.
- Develop cost-efficient syntheses
- Problem-solving capabilities that lead to novel solutions
- Quickly develop phase appropriate syntheses
- Remove hazardous chemistry
- Developing robust crystallization solutions
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
» Learn More about High Potency API (HPAPI) Handling & Development
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
