J-Star Research

The management team and staff at J-STAR have extensive experience in pharmaceutical process research and development that spans many decades of practical, hands on expertise. Clients seeking to improve troublesome steps in a process, reduce the cost of goods by removing expensive or poorly performing steps, or re-design an entire route for one of their potential products or key intermediates, will find value added input at the chemistry level from the team at J-STAR.

The process research team works closely with the analytical team to integrate the chemistry and analytical controls into the process at an early stage of the development cycle. The process research is then documented into a JACS style development report that outlines the chemistry and synthetic approaches that were tried as part of the synthetic development effort. This development report also includes a detailed experimental with supporting analytical data for the successful chemistry that results from our effort.

The experimental that is part of these development reports is much more detailed than any journal publication. When coupled with our analytical and cGMP capabilities, the process research we provide is an essential groundwork for any compound that is just advancing from nomination at the discovery phase into clinical trial development. The process we develop provides the foundation of the ultimate manufacturing process, and should not need any changes (at a later date), to the synthetic strategy or bond forming steps used to prepare the API.

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. We are skilled at HPLC / GC method development and validation, structural elucidation using LC-MS and NMR and stability studies as listed as below.

1. 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

Early identification of an optimal solid state form is an important step in the development of an active pharmaceutical ingredient. Physical properties such as solubility, stability, and hygroscopicity as well as aspects such as purification, manufacturing complexity, and bioperformance can be tuned and improved upon by isolation of the target compound in the appropriate solid state form.

At J-Star Research, we can design and conduct a targeted form screen to address a variety of solid state issues you might be experiencing.

• Is there a crystalline form of my compound?
• Is there a crystalline form with better properties?
• Do I have the most stable form?
• Are there any undiscovered polymorphs?
• Are there any solid state forms which might impact my process?

Solid State Form Screening Services

At J-Star Research, we offer several solid state form screening services which can be customized to meet your needs.

• Crystal Discovery Screen
  • Find the first crystalline form with material amounts ranging from tens of milligrams up to grams of material
• Salt & Cocrystal Screens
  • Discover a crystalline from with improved properties
• Polymorph Screen
  • Screen for undiscovered polymorphs
• Thermodynamic Stability Form Screen
  • Probe thermodynamic form stability as a function of temperature and water activity
• Process Robustness Screen
  • Screen the isolation process for form transition temperatures and activity points within the process space to ensure process robustness

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.

We design and conduct 96-well high throughput catalyst screening of reaction specific class variables based on published scientific knowledge and more than 15 years of industrial experience in catalysis research.

Once a practical synthetic route has been demonstrated and the critical process research required for scale-up has been performed, J-STAR can then provide API prepared under cGMP guidelines to support Phase I human clinical trials. This is typically done after supplying sub kilogram quantities of material for GLP toxicology studies.

We have two kilo lab cGMP production suites for cGMP Synthesis, each with an 8’ bench hood, a 12’ walk-in fume hood, bench space and dedicated vacuum drying ovens. These are air-lock entry, limited access suites, which are supplied with HEPA filtered air and contain ceiling tiles, flooring and fume hoods constructed from non-shedding materials. The reactor sizes available for these suites range from 5L to 100L, which should allow for material preparation in the range of about 5 kilos.

These reactors are jacketed with temperature control ranging from -60°C up to 150°C. Production is performed using a batch record prepared specifically for each individual product. In addition to the production suites, we have a team of trained analytical chemists to release in-coming raw materials, perform in-process assays and to release intermediates and API. Our analytical team will also develop and validate the methods used during the GMP campaign.