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 is focused on providing high standards in Quality Assurance in every aspect of the cGMP synthesis and manufacturing process. This is achieved through our focus on our quality systems management. Dedicated quality assurance personnel ensure that documentation and records, SOP’s and laboratory controls are maintained. This group is also responsible for reviewing batch record preparation and execution as well as analytical support. Our Quality Assurance team works closely with clients to facilitate site audits, implement special requests and manage any GMP issues that arise during the manufacturing process.
J-STAR has a dedicated team of analytical chemists to ensure that Intermediates and API manufactured materials are properly evaluated and conform to the assigned purity specifications using properly qualified or validated methods. This team has the capability to develop, qualify and validate analytical methods for the following test methods, many of which are performed in our limited access quality control release laboratory:
▪ HPLC for chemical purity
▪ HPLC for chiral purity
▪ Proton, Carbon, Fluorine and Phosphorus NMR (400 MHz and 300 MHz)
▪ Optical Rotation
▪ KF Titration
▪ Residual Solvents by GC (headspace and direct injection)
▪ Analysis of thermal properties (DSC and TGA)
▪ Ultraviolet Spectroscopy
The following analytical results are obtained by a qualified outside analytical laboratory and reviewed by our QA and QC group:
▪ Combustion Analysis
▪ Heavy Metals Analysis
▪ Trace Metals Analysis by ICP or AA
▪ Loss on Drying
▪ Residue on Ignition
▪ Ion Chromatography
▪ X-Ray Powder Diffraction
J-STAR offers stability services for APIs and isolated process intermediates. Qualified stability chambers are available on-site which are operated and maintained under standard ICH conditions of:
▪ 25°C/60% RH
▪ 30°C/65% RH
▪ 40°C/75% RH
We have the ability to identify impurities and degradants that form in the API upon storage using LC/MS and comprehensive NMR techniques. In addition to identifying these degradants, we can then synthesize them to confirm the structure, to provide material for response factor determinations, and for use a reference standard.