Since the Pharmaceutical Development business unit in Asymchem Laboratories Co., Ltd (SHE: 002821.SZ; “Asymchem”) started operating two years ago, significant progress and tremendous accomplishment have been achieved. More than 40 projects have been successfully delivered and drug product development technical capabilities have been substantially improved. Recently Solid State Science and Pre-formulation Lab (SSSPL) was established which aims at laying a concrete foundation for formulation development and improving drug product quality. The new lab will focus on solid form screening and characterization, crystallization process development and preformulation research. The new lab will play a critical role in Asymchem’s “ API + Formulation” strategy and also streamline the transition of a project from API to formulation.
The SSSPL will definitely further reinforce and integrate Asymchem’s position as a "CMC+ Clinical Research" one-stop service provider which is strategically important to the business continuous growth and sustainability. Through SSSPL, we will expand and deepen the collaboration with domestic and international pharmaceutical & biotech companies in future.
To better support SSSPL, the organization structure, working procedure and experimental equipments have been optimized and upgraded already. In addition to further enhance the solid form screening and single crystal culture analysis, new capabilities such as crystallization process development, integrated pre-formulation research etc. have been established as well.
Solid state science is to conduct solid form screening and select stable solid form for late stage development. Crystallization process development contributes to the crystallization process scale-up and assures the target form can be achieved. At the same time, crystallization process development can provide useful technical support in the crystallization process troubleshooting and late stage process development and optimization.
Pre-formulation research is critical to drug product formulation and process development. A stable, bioavailable and manufacturable formulation highly relies on rigorous pre-formulation work. Pre-formulation research in Asymchem includes but not limited to solid-state characterization, solubility profiling, stability study, and excipients compatibility study and drug technical developability assessment etc.. In addition, preclinical formulation development for DMPK and toxicity studies can also be provided by SSSPL.
With the establishment of the SSSPL, the collaboration between API and Formulation is further streamlined and strengthened. Systematic preformulation study would provide useful information and knowledge for the design and development of a safe, effective, robust, and easy-to-use formulation.
Polymorph screening is to find all possible crystal forms through a variety of experimental designs given limited time and number of experiments. Because a new crystal form identification highly depends on the number of experiments conducted, the crystal structure prediction simulation which is based on cloud computing technology can help find more new forms and compensate the limitation of experimental screening. XtalPi is a leading technology company focusing on cutting-edge technologies such as computational physics, quantum chemistry, molecular dynamics, artificial intelligence and cloud computing. Through the cooperation with XtalPi, Asymchem combines traditional experimental screening with computing prediction. Through large scale and high performance cloud computing, the solid form screening and selection process can be accelerated, and screening time and cost can be reduced accordingly and more reliable crystal forms can be delivered to our clients. A reliable crystal structure analysis method Cryogenic transmission electron microscopy will also be applied to compounds that are difficult to grow single crystals
The crystallization process development can assure the consistent crystal form and successful crystallization process scale-up can be achieved from early to late clinical stage. Through crystallization process development and optimization, not only crystal properties and production efficiency will be significantly improved but also energy consumption and waste emissions from crystallization process will be greatly reduced. Furthermore, the reduction of environmental pollution and lowering down of production costs are very helpful in improving drug competitiveness.
Asymchem fully utilizes excellent opportunities of pharmaceutical industry at present which is under leap-forward development. We have established the full value chain service and becomes a leading one-stop service provider. SSSPL as an important strategic layout in Asymchem’s ecosystem, acts as a bridge connecting API with formulation and transforming molecules to medicine. We will continue to improve and innovate, striving to provide the best service with the highest delivery quality to our esteemed customers.