Process Development Overview
The R & D team of our company is composed of experienced scientific research experts from China and abroad. It is characterized by technological innovation and comprehensive technical ability. It has extensive and in-depth professional knowledge in the field of synthetic organic chemistry. It can independently design compound synthesis routes and has rich experience in dealing with complex compounds.
Through continuous optimization of the process to obtain mature and easy to industrialize the process route, the key process parameters database was established. According to the characteristics of the process route, complete impurity profiles of starting materials, intermediates and APIs are established, so that the prepared APIs meet the requirements of generic drug preparations, thus realizing industrial production of a certain scale.
Process development, optimization, production and writing CMC content
Synthesis process development and optimization
Optimization and determination of important process parameters
Optimize and determine post-processing methods
Optimize and determine the purification method
Process risk assessment and control (assess the hazard level of the process)
Process Validation and Process Transfer
Analytical Method Development and Validation
Trial/exploratory stability study (pre-test)
Separation of impurities in regulated starting materials, intermediates, APIs and drug products using various techniques such as HPLC
Identify, prepare, control and establish reasonable quality standards for impurities involved in the project
Rapid process development of starting materials and APIs with significant advantages in material cost control
Arrangement and writing of application dossiers CMC
Pharmaceutical Analytical Method Development and Methodology Validation
Based on the relevant requirements of ICH and national pharmacopoeias, the development and validation of analytical methods for pharmaceutical starting materials, intermediates and APIs from R & D and production to registration application,
Analytical method development and validation for related substances/assay, including forced degradation
Development, qualification or validation of chiral methods for pharmaceuticals
Method development, qualification or validation of residual content of impurities
Development, qualification or validation of KF and CKF analytical methods for moisture
Development, qualification or validation of thermogravimetric analysis (TGA) methods
Cleaning Validation Test Method Development, Validation or Verification
Compilation of Submission in CTD Format (DMF)
Drug Stability Studies
Experimental/exploratory stability study (pre-experimental) and stability study in drug registration stage
According to ICH Q1A, design corresponding stability test according to drug properties
Stability data of analytical samples under different conditions were evaluated according to ICH Q1E
such as trend of data over time
Comprehensive analysis to establish the shelf life and shelf life of samples
Equipped with strong light test chamber and stability test chamber
Storage conditions: 30°C/40°C/75%RH, 30 °C/65%RH, 25°C/60%RH and light
Stability study constant temperature and humidity chamber; Real-time temperature and humidity monitoring (dual system); automatic alarm system
Compilation of Submission in CTD Format (DMF)
Drug impurity analysis
Separation of impurities in regulated starting materials, intermediates, APIs and drug products using various techniques such as HPLC
Complete 1D/2D NMR, LCMS, EA, HRMS, IR, UV data were collected to identify the structure of the separated impurities
Isolation and structure identification of forced oxidation degradation products
Compilation of Submission in CTD Format (DMF)
