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Analytical + Quality Control
Analytical Method Development & Quality Control
Serán has extensive solid-state analytical capabilities to assess physical/chemical forms of crystalline and amorphous API and drug products. We have analytical services spanning method transfer, development and qualification, and a state-of-the-art QC Lab to support GMP release testing and stability assessment.
Two laboratories to support you from early development through cGMP.
Serán maintains two well-equipped analytical facilities: a formulation development laboratory, and a cGMP Quality Control laboratory.
In our formulation development lab, we deploy a variety of techniques to assess the physical and chemical properties of drug substances and prototype formulations. Careful collection and evaluation of the right data enables rational scientific choices leading to optimized formulations, even in Phase 1.
Our development lab also has the capability to develop new analytical methods for your compound. All methods are qualified or validated to ensure accuracy and consistency.
Our QC lab ensures that raw materials used in cGMP manufacturing, as well as intermediates and dosage forms manufactured at Serán, meet applicable quality standards. The QC lab also performs chemical and physical stability assessments of intermediates and drug product, environmental monitoring testing of our manufacturing suites, and swab cleaning verification of our equipment after manufacture.
ANALYTICAL SCIENCES
- Fundamental molecular characterization
- Pre-formulation assessment and formulation screening
- Advanced solid-state characterization
- Exploratory stability
- Dissolution assessment
- Modeling and predictions
ANALYTICAL DEVELOPMENT
- Method Transfer
- Method Development
- Method Optimization
- Method Qualification
- Development batch stability (IND-enabling)
- ICH Stability
- Data Trending & Predictive Modeling
- Cleaning method development and validation
QUALITY CONTROL
- Raw materials testing
- Finished product release testing
- In-process Testing
- Cleaning verification
- Stability testing (ICH)
- Environmental monitoring and testing
- Full method validation
- Mature quality systems and management experience
- State-of-the-art Quality Control Laboratory
- Successful audit and inspection history
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