CDMO一体化平台（CDMO）
INTEGRATED CMC PLATFORM
Service introduction
API Process R&D
Across All R&D Stages
- Preclinical
- Clinical（Stage I~III）
- Commercial
All-Round Service
- Process R&D
- Scale up Manufacturing （Including GMP）
-
Global Regulatory Affairs（CMC dossier preparation）
All Kinds of Reactions
- Routine Reactions
- Asymmetric Catalytic Hydrogenation
- High Temperature Reactions
- Low Temperature Reactions
Reasonable Synthetic Route Design
Prompt Process R&D
Fit for Purpose Process 0 ptimization
Process Safety Evaluation
Stable Commercial Manufacturing&Sustainable Process 0 ptimization
Preparation, Purification and Isolation of Impurities
Study of Critical Process Parameters
Control Strategy of Starting Materials and Intermediates
起始物料及中间体
的控制策略
关键工艺参数的设定
杂质的制备及
分离纯化
稳定的商业化生产
及持续的工艺优化
Preformulation Study
Physicochemical Properties
- PKa /LogP, solubility and acid base properties, etc
- Characterization of solid state properties: crystallinity, crystal form, thermodynamic properties, hygroscopicity, specific surface area, etc
- Stability
- Detection and determination of solvent complexes/hydrates
Single Crystal Culture and Stereostructure Confirmation
- Screening of solvent for single crystal culture
- Multiple methods to grow single crystals
- Confirmation of molecular stereostructure
Polymorphism Screening and Salt Form Selection
- Solid state characterization and quick solubility test of initial compounds
- Screening test and evaluation of polymorphism and salt forms
- Further evaluation of selected polymorphs /salt forms
Excipient Compatibility Study
- Compatibility of excipients / formulation under accelerated conditions
Formulation Development
Formulation and Process Development
- Study on Physicochemical Properties of APl
- Reverse study on RLD (generics)
- Formulation Process Development
- Selection of Packaging Materials/Stability Study
Scale up, Technical Transfer
- Parameter Optimization
- Process Scale up, Validation
- Technical Transfer
Manufacturing or Transfer of cGMP Clinical Trial
- Manufacturing of Clinical Batches
- Stress Testin
- Stability Study
Analytical Development and Quality Research (GMP)
Method development, validation and release test
- Content and related substance analysis
- Chirality
- Counter ion
- Dissolution
- Genotoxic impurity （LC-MS/GC-MS）
- Residual solvent
- Heavy metal elemental analysis
- Physicochemical(XRPD/PSD/TGA)
- Excipient release tes
Stability Research
-
Stability research of new active substances and medicinal products
Stability research under long-term storage and accelerated condition
Photostablity research
-
Stability research
Manufacturing process change research
Forced degradation test/stability evaluation under accelerated condition
Impurity Related Service
- Stability-indicating method development for related substance analysis and method validation
- Impurity isolation and structure elucidation
- Impurity standard, labeled compound and metabolite’s synthesis and preparation
- Impurity standard characterization and qualification
- Synthetic route evaluation and Genotoxicity prediction
- GTIs method development, validation and sample test
- Heavy metal elemental analysis and residual solvent method development, validation and sample test
- Degradation pathway research of pharmaceutical degradants
Regulatory Affair
The regulatory affair team provides global registration and declaration full process service.
Consulting/Gap Analysis
· Global Regulatory Strategies · Application Plan · Feasibility Assessment
· Regulatory Guidance for R&D · Gap Analysis
Regulatory Agency Interactions Support
· Pre-IND meeting, etc
Writing & Review of Regulatory Documents
（Take IND application as an example）
· CMC · Non-clinical · Clinical
Application Submission
· Paper or electronic submission to the regulatory authority system: IND, NDA, ANDA, conformance evaluation, etc
Dosage Forms
口服制剂
片剂
速释片(口崩片/分散片)
缓/控释片
肠溶片
微丸
丸芯上药
胶囊剂
硬胶囊
软胶囊
口服液
透皮给药
软膏剂
硬膏剂
涂剂
注射剂
注射液
冻干注射剂
滴眼液
滴眼液
| Immediate Release Tablet |
Sustained/Controlled Release Tablets | Enteric Coated Tablets | Drug Layering | Hard Capsules |
| Soft Capsules | Oral Liquid | Ointments | Plaster | Paint |
| Injection Liquid | Lyophilized Injection Powder | Eye Drops |
Experimental Instruments
| FRD LAB（PART） | |
| High Shear/Mix Granulator(Glatt) | Vibration Powder Sifter |
| Multifunction fluidized bed(Glatt) | Single Punch Tablet Press |
| Granule Milling Machine(Co-mill) | Rotary Tablet Press |
| Granule Sieving Machine(Co-mill) | High-efficient Coating Machine |
| Bulk/Tapped Density Test仪 | Blister Packaging Machine(Al/Pvc, Al/Al) |
| Flowability Tester | Softgel Encapsualating Maching |
| Disintegration Tester | Lyophilizer（Christ） |
| Analytical Equipment（PART） | |
| ICP-MS | Optical Rotation Tester(OR) |
| HPLC | Dissolution Tester(DIS)仪 |
| UPLC-MS/MS | Infrared Spectrometer(IR) |
| GC | UV-Visible Spectrophotometer |
| GC-MS | Osmotic Pressure Detector |
| HPLC-HRMS | DSC |
| SEM | Laser Particle Size Analyzer |
Quality system
Service advantages
ADVANTAGE
Shorten the time to market
Experienced Team Members
Core members come from world-renowned generic as well as innovative drug companies in the U.S. and China, and have been responsible for the development of numerous generic drug and innovative drugs FDA/NMPA/EU/WHO registrations.
Proven track record in API and formulation development, scale up, production technology transfer, and method development and validation
Integrated Service
Integrated services are provided from the development of API, formulation process development, scale-up production, process verification, BE clinical trial, clinical trial sample analysis, to dossier preparation and regulatory submission.
Shorten the development cycle, speed up the IND application, improve the probability of passing BE, and reduce the development cost.
Efficiency, Quality, Customer Experience
Advanced and well-equipped instruments and equipment guarantee the high quality with high efficiency.
Core team members are responsible for project management to achieve the best customer experience.
Xihua Headquarters
Address：Building 5, 6 and 7, Lane 118, Furonghua Road, Pudong New Area, Shanghai
Learn more>Business Consulting
Overseas
Tel：+01-609-921-7115 (US)
Fax: +01-609-921-7116 (US)
Other Consultations
China
Email：IR@xihuasci.com
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