The process department currently has a total area of about 6000 m2, including 2000 m2 of R&D lab, 800 m2 of non-GMP pilot scale up workshop, 1000 m2 of GMP API workshop and 1000 m2 of analysis and testing center, 800 m2 of GMP compliant QC lab, and 200 m2 of microbiology lab. A strong R&D team supports API process development services covering areas such as synthesis, analysis, microbiology, project management and QA and QC. The team has rich experience in innovative drugs, consistency evaluation, successful R&D of improved new drugs, in China-US dual filing and in project management.
From pre-clinical trial synthesis, process development to commercial production stage and the whole supply chain system of R&D, procurement and production of enterprises, we provide innovative process development and large-scale production services for enterprises. With the establishment of GMP-compliant API workshops and the upgrading level of pharmaceutical production and quality management systems, we are able to provide customized services for GMP production, helping more R&D-oriented companies to carry out practical technology transformation, shorten time-to-market and promote commercialization.
One-stop Process R&D Service
Medicilon's Process Department aims to meet customers' needs for a one-stop service for API development, and to utilize our extensive medicinal chemistry experience to efficiently drive our customers' drug development projects, to facilitate the development of new drug to enter earlier into the clinical phase, and to effectively help our customers to control the cost of new drug development.
From CRO to CDMO
With years of experience and the construction of laboratories, Medicilon Process Department can not only perform R&D, testing and stability studies of generic drugs for customers, but also R&D, production, testing and stability studies of innovative drugs in clinical phase I and phase II, gradually developing from process R& to industrial commercial production and transforming from CRO to CDMO
Rich Configuration of Equipment
The experimental equipment are well equipped and our technology is advanced, and the main equipment include different types of glass reactors, rotary evaporators, stainless steel reactor, vacuum drying oven, blast oven, temperature control unit, precision filter, two-in-one filter, centrifuge, airflow pulverizer, turbo pulverizer, etc. The main analytical instruments include UPLC, HPLC, GC, IC, LC-MS, GC-MS and other chromatographic analyzers, as well as laser particle size sizer (PSD), 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) UV spectrophotometer, cyclometer, muffle furnace, melting point meter, moisture meter (KF) conductivity meter, TOC and ICP-MS, etc.
Through continuous investment in laboratory instrumentation and the establishment of GMP workshops, we are committed to providing customers with high-quality products and services through productive, rapid, problem solving and active communication and to realize the shift from CRO to CDMO. We have expanded the scope of pharmacy services while enhancing the capability and level of pharmacy services.
Medicilon provides customization of starting materials and design and confirmation of synthesis process routes. We conduct research on the product to be developed, review a large amount of data, analyze the synthesis route and the original source of synthesis, and analyze the synthesis equipment and synthesis cost to understand whether the synthesis route has intellectual property issues, whether the production cost is acceptable, whether it can meet the green chemistry, etc. We conduct route screening, process optimization, quality research, and process validation.
Our services
Route design & screeningSalt screening, crystal structure study and crystal process developmentSalt ScreeningCrystal structure screeningCrystal structure process studies (laboratory test processes, kilo-scale processes)Statistics and experimental design by using quality by design (QbD) and multivariate data analysis Quality studies of APIs and intermediatesDevelopment and validation of analytical methodTechnology transfer and process validation
Whether it is an emergency route screening at the pre-development stage or a cost-effective route screening at the formal drug development stage, Medicilon helps customers to select the API process routes which is stable, quality reliable, low cost, process safe, environment friendly and suitable for large-scale production by evaluating the technical feasibility, equipment availability, availability of principles and reagents, number of reaction steps, patent protection and environmental impact, etc.
The solids screening platform of Medicilon‘s process department strictly follows the registration regulations and regulatory requirements of the NMPA in China and the FDA in the U.S. to study and control the solid forms of drug molecules in APIs and formulations, and is able to develop the most effective screening strategies based on the characteristics of the substances, including but not limited to crystallization methods, selection of solvent, selection of the suitable salt-forming acid and base.
Our services
Discovery
Various salt forms/crystal structure/co-crystal of APIs
Evaluation
The drug-forming properties of different crystal structure of APIs
Development
API crystallization production process to obtain target crystal structure, morphology and particle size
Salt Screening
Goal
Improve the drug propertiesDiscover the most suitable salt form for developmentEnsure the protection of the effective patentCircumventing the prior technology patents
Technology package
Characterization of free state propertiesSolubility in different solventsSelection of the suitable salt-forming
acid and baseMultiple salt formation techniquesCharacterization of physicochemical propertiesStudies of solid state and solution stabilitySalt form selection and recommendationPatent deliverables
Salt Screening Process

Co-crystal Screening
Goal
Improve the defects of the free stateDiscover the most suitable cocrystal for developmentEnsure the protection of the effective patentCircumventing the prior technology patents
Polymorph Screening
Goal
Discover the most suitable crystal structure
for developmentEnsure the protection of the effective patentCircumventing the prior technology patents
Technology package
Analysis of existing technologyTechnologies of multiple crystallizationCharacterization of physicochemical propertiesStudies of solid state and solution stabilityAnalysis of the relative stability of polymorphCrystal structure selection and recommendationPatent deliverables
Polymorph Screening Process

Qualitative, quantitative and limit analysis method development and validation
Analysis of raw material crystallinity or impurity crystal structureQualitative and quantitative analysis of raw material crystal structure in formulationsDevelopment & validation of particle size distribution analysis method

X-Ray Powder Diffraction (XRPD)
Medicilon's process department has established a biotechnology platform with corresponding chemical technology platform, testing platform and GMP production platform. The biotechnology platform focuses on the combination of chemical synthesis and bioenzyme-catalyzed synthesis, on the research, development and application of bioenzymes, on the R&D and production of pharmaceutical intermediates and APIs in using green biotechnology, and on providing high-end CRO and CDMO services and testing and quality research services for pharmaceutical companies.
Biological enzyme catalysis is characterized by high efficiency, specificity, versatility and variability, and mildness of reaction conditions. At present, the biotechnology platform has established dozens of large bioenzyme libraries, such as ketone reductases (KRED), esterase, imine reductase (IRED), nitroreductase (NTR), cyclooxygenase (COX), amidase, etc. In addition, we will also carry out research in the direction of immobilized enzymes and coenzymes.
Our services
Study of enzyme-catalyzed conversion processDevelopment and validation of analytical methodsResearch, development and application of bioenzymes
