Our state-of-the-art microbiology, biochemistry and analytical chemistry labs offer certified analytical methods for protein characterization.
A product-specific set of analytical procedures is developed for each product to monitor critical control points during the process and to comprehensively characterize the end product.
We follow GMP guidelines and meet the regulatory authorities’ requirements for the analytical determination of protein actives’ general characteristics, molecular structure determination, identity, activity, purity and safety, as well as the stability of the produced therapeutic proteins during product characterization and process validation.
In our biochemistry and microbiology labs, we carry out the required analysis to secure our GMP standards for raw materials, water and environmental control.
Our analytical competence includes:
- Electrophoretic techniques: agarose gel electrophoresis, SDS PAGE, native PAGE, IEF, 2D gel electrophoresis and western blot
- Capillary electrophoresis techniques (e.g. CZE, cIEF)
- HPLC techniques: RP-HPLC, IEX, SEC, affinity chromatography and peptide mapping
- Spectrophotometric tests
- Product-specific activity measurements
- N-terminal amino acid sequencing
- DNA detection (THRESHOLD system, PicoGreen assay)
- Quantification of host cell proteins (THRESHOLD system, generic assay)
- Endotoxin determination by LAL test
- Quantitative PCR and/or RT-PCR
- Quantification of gene expression
- Microbiological testing (e.g. determination of TAMC and TYMC, determination of foreign microbiological contaminants, determination of antibiotic resistances and microorganism identification methods, determination of phages)
- Trace analysis of organic solvents by headspace GC
- Trace element analysis by AAS and ICP-OES
- Detection of antibiotic traces in protein solutions
- Antifoam agent detection by GC-MS
- Stability testing
- Environmental monitoring (air and surfaces)
- Water analysis as per European Pharmacopoeia (e.g. TOC (total organic carbon), bioburden and endotoxin)
- Molecular biological techniques: plasmid restriction analysis, strain specific PCRs, determination of plasmid copy number
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