Medicilon lessons online open now! [Cloud Archives] series will give you a detailed introduction to the lecturer’s research fields and related information. Today, let us approach Director Zhou Xiaotang and Medicilon CMC Preparation Department!
From CRO to CDMO
With the vigorous development of domestic innovative drug research and development, in order to better meet customer needs for one-stop service of formulation research and development, Medicilon’s preparation department has built a new GMP-compliant oral solid preparation workshop, and at the same time improved the drug production and quality management system Level. In this way, we can not only carry out the research and development, inspection and stability research of generic drugs for customers, but also carry out the research and development, production, packaging, inspection and stability research of the clinical phase I and phase II of innovative drugs, and open the CDMO service.
The preparation department currently has a total area of about 4000 square meters, including 1500 square meters of various dosage form research and development laboratories, 500 square meters of non-GMP pilot scale-up workshop, 1000 square meters of GMP oral solid preparation workshop and 1000 square meters of GMP-compliant QC laboratory. The experimental equipment is complete and the technology is advanced. The main preparation equipment includes jet mill, Thermo hot melt extruder, multi-functional fluidized bed (granulation, Wurster column pellet coating), wet granulator, dry granulation Machine, hopper mixer, rotary tablet press, automatic capsule filling machine, high-efficiency coating machine, aluminum-plastic packaging machine, colloid mill and freeze dryer, etc. The main analytical instruments include UPLC, HPLC, GC, IC, LC-MS and GC-MS and other chromatographic analyzers, as well as laser particle size analyzer (PSD), automatic dissolution tester, constant temperature and humidity test chamber, differential scanning calorimeter (DSC), thermogravimetric analyzer (TGA), X-ray powder diffraction (XRPD), nuclear magnetic resonance (NMR), Fourier transform infrared spectroscopy (FT-IR) and ICP-MS, etc.
Through continuous investment in laboratory equipment and new oral solid GMP workshops, the business capability of Medicilon’s preparation department has been transformed from CRO to CDMO, which has expanded the scope of pharmaceutical services and improved the capabilities and levels of pharmaceutical services.
Lab Instruments of Medicilon
Solutions to formulation challenges
Professional technology platform for insoluble innovative drugs
In the development of pharmaceutical preparations, there are more and more low-solubility drugs, and about 70% of new drug candidate compounds are poorly soluble drugs. Medicilon’s preparation department uses unique technologies to solve the solubility and permeability of drugs, improve the success rate of drug development, shorten the development time, and promote compounds to become truly valuable new drugs. Technical platforms for solid dispersion (such as hot melt extrusion, etc.), micronization, solubilization, inclusion compounds, in vitro dissolution/in vivo PK comprehensive evaluation, etc. have been established and improved.
Professional high-end preparation technology platform
The preparation department of Medicilon not only has outstanding performance in the development and research of traditional dosage forms, but in recent years has also established inhalation, ophthalmic, transdermal, sustained and controlled release, and new particle system. Technology platform for high-end preparations.
Technical R&D team with advanced technology and efficient operation
Medicilon’s preparation department is an experienced R&D team with advanced technology and efficient operation. There are nearly 100 employees, of which more than 40% have a master’s degree or a doctoral degree, and more than 95% have a bachelor degree or above.
The team focuses on R&D services for insoluble drugs and high-end formulations. Zhou Xiaotang, director of the preparation department, has rich R&D experience in class I innovative drugs, class II improved new drugs, generic drugs, and consistency evaluation. The Sino-US dual reporting experience and rich project management experience can promote the efficient operation of the project and smooth application.
One-stop formulation development service
Medicilon’s preparation department can undertake a full set of preparation research (R&D + clinical sample production + stability), safety evaluation, packaging material compatibility, filter verification, packaging tightness, pre-BE and BE research and other services to satisfy customers All needs for one-stop formulation research and development services.