ABOUT
Preparation ResearchThe 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, 1000 m2 of analysis and testing center, 800 m2 of GMP compliant QC lab, and 200 m2 of microbiology lab. With the establishment of GMP-compliant API workshops and the upgrading 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, shortening time to market and promoting commercialization.
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 development of improved new drugs, in China-US dual filing and in project management. From pre-clinical trial synthesis, process development to commercial production and the whole supply chain system of R&D, procurement and production of enterprises, we provide innovative process development and large-scale production services.
We assess the synthesis equipment and synthesis cost to understand whether the synthesis route has intellectual property issues, whether the production cost is acceptable andconfirm whether it can meet green chemistry criteria. We conduct route screening, process optimization, quality research, and process validation.
Optimization of API Production Process
The Medicilon Process Department applies the concept of QbD to the R&D of API process, to create a suitable process route tailored for customers, and optimizes the API production process to improve product quality and process efficiency.
Generic Drug Process Study & Filing
We provide generic API manufacturing process development, optimization, production and declaration (DMF) services.
Innovative Drug Process Study & Filing
We provide API process development, optimization, manufacturing, and filing services, based on IND requests in preclinical and clinical phases.
Process Department Solid Form Screening Platform
The solid screening platform of our process department strictly complies with the registration regulations and regulatory requirements of the NMPA, FDA and other regulatory authorities. This department studies and controls the solid morphology of drug molecules in API and preparations and can formulate the optimal screening strategy according to the material characteristics, including but not limited to crystallization method, solvent selection and ion selection.
Biotechnology Platform
Our Services：
•Study of enzyme-catalyzed conversion process
•Development and validation of analytical methods
•Research, development and application of bioenzymes
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 production of pharmaceutical intermediates and APIs using green biotechnology, and on providing high-end CRO and CRDMO services, testing and quality research services.
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.
Pharmaceutical Preparation- Medicilon's preparation laboratory and workshop area is about 4,000 square meters, with 100 professional R&D teams, of which more than 40% are masters/doctors, and more than 95% are graduates. The team has rich experience in the successful development of innovative drugs, consistency evaluation and experience in China-US dual filing and project management. The Medicilon pharmaceutical preparation R&D team has successfully cooperated with well-known global large and medium-sized pharmaceutical companies and has accumulated 19 years of experience in the research and application of innovative drugs and generic drugs. We provide one-stop and systematic preparation R&D services covering innovative and generic drugs to meet the needs of customers at different stages of R&D.
(1) Provide one-stop preparation development services
Medicilon can undertake a full set of preparation research (including clinical sample production and stability teasting), safety evaluation, packaging material compatibility, filter membrane verification, packaging sealing, pre-BE and BE research and other services to meet all your needs.
（2） From CRO to CRDMO
Medicilon has a new purpose built GMP-compliant oral solid preparation workshop and can carry out inspection and stability research of generic drugs, as well as of clinical phase I and II of innovative drugs, with our service capabilities having expanded from CRO to CRDMO activities.
(3) Rich instrument and equipment configuration
Rich instrument and equipment, advanced technology
• The main preparation equipment we use includes jet mill, Thermo hot melt extruder, Spray dryer, Multifunctional fluidized bed (granulation, Wurster column pellet coating), Wet granulator, Dry granulator, Hopper mixer, Rotary tablet press, Automatic capsule filling machine, High-efficiency coating machine, Granule packaging machine, aluminum-plastic packaging machine, Emulsifier machine, Colloid-grinder, Soft capsule making machine and freeze dryer.
• The main analytical instruments we use include chromatographic analyzers such as UPLC, HPLC, GC, IC, LC-MS and GC-MS, and Laser particle size analyzer, Auto Dissolution Tester, constant temperature and humidity test chamber, differential scanning calorimeter (DSC), Thermal Gravimetric Analyzer (TGA), X-ray Powder Diffraction (XRPD), Nuclear Magnetic Resonance (NMR), Fourier Transform Infrared Spectroscopy (FT-IR) and ICP-MS.
- Service Scope
- Innovative drug preparation research
- Preformulation
Feasibility assessment
Dosage form selection
Compatibility of raw materials
- Formulation & Preparation Process Research
Formulation process development
Formulation optimization
Quality development
- IND, Phase I Clinical Trial
Pilot scale-up
Quality research and stability research
Phase I clinical samples
- Phase II, III Clinical Trial
Prescription and manufacture process scale-up
Change
- NDA
Prescription process confirmation
Quality research
Process validation
- Generic Drug Formulation Studies (QbD)
Target Product Quality Profile QTPP
Critical Quality Attributes CQAs
Risk Assessment, Critical Material Attributes CMAs, Critical Process Parameters CPPs, DoE,
Control Strategy
- High-end Preparations TechnologyMedicilon Formulation Department has outstanding performance in the development and research of traditional dosage forms, and has established Inhalation Drug Delivery, Ophthalmic Drug Delivery, Transdermal Drug Delivery, Sustained-and Controlled-Release Drug Delivery, Microparticle Drug Delivery and other preparations technology platforms in recent years.
Insoluble Innovative Drug Technology
Approximately 70% of new drug candidates are poorly soluble.
Medicilon’s Formulation Department solves the problem of drug solubility and permeability to improve the success rate of drug development, shorten the development time and enable compounds to become valuable new drugs. Medicilon has established and perfected technical platforms such as solid dispersion (such as hot melt extrusion, spray drying, etc.), micronization, clathrate, emulsions, in vitro dissolution/in vivo PK comprehensive evaluation, etc.
Pharmaceutical Research CDMO Service
The oral solid preparation workshop of Medicilon Pharmaceutical Department complies with GMP andcan carry out generic drug development and testing, as well as clinical phase I and II research and development, production, packaging, testing and stability research of innovative drugs. The service has been expanded from CMO to CRDMO to meet customer needs and facilitate innovative drug research and development.
Perfect Quality Management System
The Medicilon GMP preparation Analysis Laboratory has established an excellent quality management system, which can not only meet the QC inspection and release work of GMP workshop, but can also meet the requirements of long-term stability and accelerated stability research under GMP conditions for generic drug conformance evaluation.
Service Cases
Medicilon Assists Toll Biotech's TollB-001 tablets, a new class 1.1 drug, to officially approve for clinical trials by the FDA
Medicilon Assists Yuyao Biotech's STAT3 dual phosphorylation inhibitor YY201 has been approved for clinical trials
