Quality Control Testing
The Quality Control department offers expertise in testing medicinal substances and products at various lifecycle stages including early product development, in-process, release and ongoing stability indicating analysis.
Extensive capabilities cover common requirements for establishing physicochemical properties, identity, purity/impurities, activity/potency and microbiological safety testing.
A wide variety of QC methods are routinely used including tests such as,
- Physiochemical pharmacopeia tests
- HPLC
- Gel electrophoresis techniques
- ELISA
- N-terminal sequencing
- Bioburden
The Quality Assurance unit offers QA support to all operational departments on site whilst working to maintain the GMP compliant Quality system. Other key activities include maintaining the organisation’s GMP manufacturing licence whilst ensuring ongoing regulatory compliance and working closely with Qualified Persons for product certification purposes where required.
A wide variety of QC methods are routinely used including tests such as,
- Physiochemical pharmacopeia tests
- HPLC
- Gel electrophoresis techniques
- ELISA
- N-terminal sequencing
- Bioburden
The Quality Assurance unit offers QA support to all operational departments on site whilst working to maintain the GMP compliant Quality system. Other key activities include maintaining the organisation’s GMP manufacturing licence whilst ensuring ongoing regulatory compliance and working closely with Qualified Persons for product certification purposes where required.
Peptide Synthesis
Quality Control
Protein Purification
Assay Development
Polyclonal Antibody
Stability Testing
GMP Manufacture