Our company provides professional development services for active pharmaceutical intermediates (API). From preclinical synthesis and process development to commercial production, we have a complete cGMP API production line. Our manufacturing method is flexible enough to be adapted to customer needs and development phases, offering services for novel process development and scale-up production.
Service Overview
From process design, laboratory process development, and commercial production to data registration and filing, Our company's experienced analytical and quality control team provides analytical services and quality control for the entire project, providing customers with comprehensive analytical research services, including analytical method development and validation, process validation, impurity identification and separation, API and intermediate quality studies, API stability testing of APIs, etc.
- We provide starting API customization and synthesis process route design and confirmation services, conduct research on proposed product development, analyze synthesis routes and sources of synthesis raw materials, conduct route screening, optimization of processes, quality studies, and process validation services.
- We use the QBD idea when creating API processes and are dedicated to creating tailored, effective process routes and optimizing the API production process to raise product quality and process effectiveness.
- We can create clinical phase I samples, phase II samples, advanced intermediates, safety evaluation batch production, pilot scale-up production, and API small pilot process confirmation production.
- We offer services including API impurity separation and identification, quality investigations, and stability testing.
Research Capabilities
| Process Route Screening | - Route design and screening.
- Salt type screening, crystal type study and crystal type process development.
- Parameter optimization of defined routes.
- Statistical and experimental design using quality by design (QbD) and multivariate data analysis.
- Quality studies of APIs and intermediates.
- Analytical method development and validation.
- Technology transfer and process validation.
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| Production Process Optimization | - Establishment of API quality standards.
- Establishment of intermediate control standards.
- Optimization and determination of important process parameters.
- Optimization and determination of post-treatment methods.
- Optimization and determination of purification methods.
- Process risk assessment and control.
- Process safety evaluation.
- Heterogeneous mass spectrometry study.
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| Clinical Sample Production | - Pilot batch production.
- Safety evaluation batch production.
- Pilot batch production.
- Clinical batch production.
- API GMP production.
- Analytical method validation.
- Stability studies.
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| Impurity Traceability and Control Research | - Preparation and standardization of impurities/specimens.
- Quality studies.
(1) Physical and chemical properties, impurities and other key quality attributes CQA
(2) Analytical method development
(3) Content analysis
(4) Material testing, release
(5) Central control analysis
(6) Analytical method validation (HPLC methods, chiral HPLC methods, GC-HS methods) - API stability test (Influencing factor experiment, accelerated stability, and long-term stability).
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Other Research Services
Our company has years of experience and can offer R&D, analytical testing, and stability study services for both generic and innovative drugs that are in Phase I and Phase II clinical R&D, manufacturing, analytical testing, and stability study. Our company can also help with the transition from CRO to CDMO and can provide these services as the R&D process progresses from industrial commercial production to industrial production.
If you want to know more about service details, please feel free to contact us.
Related Services
It should be noted that our service is only used for research, not for clinical use.
