Welcome to J-STAR Research, Inc.
Our mission is to help pharmaceutical small molecule R&D programs succeed in all phases of development.
Chemistry Process R&D
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 capabilities needed for process development, GLP studies and GMP campaigns, including:
- HPLC / GC method development for challenging separations including chiral separations
- Method development and testing
- Method transfer / validation
- Reference standard certification
- Separation and Characterization of impurities
- Intermediate and API release testing
- Stability studies
Center for Pharma Crystallization
Headed by world class scientists, the Center for Pharma Crystallization (CfPC) is a recognized industry leader in solid form studies, crystallization process development, pre-formulation evaluation, particle engineering and DS-DS co-processing.
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
- Phase 2 and 3 formulation and process development
- Spray drying technology platform
- HME technology platform
- Co-processing technology platform
cGMP Intermediate & API Production
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
High Potency API (HPAPI) Handling & Development
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