J-STAR Research is a contract chemistry organization serving as an outsourcing partner for the pharmaceutical and biotechnology industries. Founded by Dr. Andrew Thompson, formerly of Merck Research Laboratories in The Department of Process Research,
J-Star has become a leading provider of services in organic synthesis for a variety of pharmaceutical clients globally.
J-STAR was formed to provide high quality chemistry and process research services to the chemical community. For complex synthetic organic chemistry projects, especially those with an uncertain development future, it can be difficult to find a nimble and reliable chemistry provider willing to take on new challenges. The company is privately held, which allows us to continue our focus on providing high quality chemistry services.
J-Star’s expert team of scientists and professionals coupled with solid industrial experience, a high degree of dependability, and a fully equipped laboratory ensures that all projects are delivered in full, on time and with a high degree of purity.
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.
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.
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.
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.
J-Star Research has not received any reviews.
J-Star Research has not received any endorsements.