Quality Control
At Asymchem, Quality Control goes far beyond testing against specifications; it is at the core of everything we do. We are committed to delivering exceptional science and ensuring compliance throughout the entire development lifecycle.
Our team, with an average of over 20 years of experience in the pharmaceutical and CDMO industries, brings a wealth of expertise across R&D and commercial. Our scientists have led projects at every stage of development and have implemented continuous improvement initiatives that deliver value to a wide range of stakeholders.
The Asymchem QC culture is built on collaboration and partnership throughout the method development lifecycle. With years of proven excellence in troubleshooting and providing critical method feedback, we ensure robustness at every phase—from early development through to commercial production.
Manufacturing support
- Raw material characterisation and release
- Handheld Raman ID to full characterisation
- In-process control and isolated intermediate testing
- Partner with pilot plant to provide rapid release and ensure timely decision making
- Environmental monitoring to support plant environmental permit
- Support transfer for commercial manufacture/ release
Release testing
- Full suite of chemical and physical properties tests for release
- Chromatographic- LC, GC, IC, SFC, LC-MS, GC-MS
- Spectroscopic- FTIR, NMR (ID and quantification), HH Raman
- Titration- water content, specific ion
- ICP-MS, ICP-OES, LOD, Residue on ignition
- Physical properties- particle size (wet and dry dispersion), PXRD
Stability
- Range of stability cabinets to cover clinical and ICH stability storage
- Analysis of stability checkpoints
- Review and trending stability data
- Establish proposed use periods to support clinical studies and regulatory submissions
Reference standard characterization
- Support reference standard characterisation for initial set up and re-certification
- Support QNMR for pre-clinical/ early phase through to full characterization for late-stage development
Method validation
- Stage appropriate method validation with full suite of API test methodology
- Verification of compendial methods
Instrumentation, Data Integrity and Compliance
- Equipment, instrumentation and data is maintained in a cGMP state throughout the lifecycle
- Expertise in data integrity and data management including equipment data integrity risk assessments, data life cycle and ALCOA +
- Experienced in internal, external and regulatory inspections
