Process development services
Our process development services are enhanced by extensive work in immunology, cell biology, molecular biology and protein chemistry. From intense work on the development of our own pipeline products we have acquired a very broad portfolio of analytical methods. This we bring in into our service offering for our clients.
Process Transfer and Process Development
We develop upstream processes (USP) and downstream processes (DSP) using our platform or a customized variation. Processes can also be transferred from any other development or manufacturing site for improvement. We are experts in perfusion and fed-batch processes, including their establishment and characterization. We use all state-of-the-art technologies (2 Ambr-systems, batteries of small-scale bioreactors from 1 to 10 L working volume) in USP development. Machines from GE (Äkta Avant and Pure series) are available in our laboratories for protein purification development.
Analytical Services and Stability Studies
Glycotope has proven experience in customized bio-analytical method development, validation and routine application.
Glycotope’s analytical services strongly support customers for specific biological assay development at any point along the product development path. We provide ISO9001-compliant analytical services and work together with our clients to develop and set-up efficient first-class quality control management to ensure the highest product quality and to help reduce the overall time and cost of product development.
The services include:
- Development of various analytical services including identity, purity and potency testing
- cGMP compliant method validation and transfer
- Performance of stability studies according to ICH guidelines
- HPLC (SEC, IEC, RP)
- Endotoxin content (LAL-test, Haemotox rFc, EndoLISA®)
- Host cell protein (generic kits, GEX®-specific ELISA, or development of customized tests)
- Process related impurities, e.g. Protein A, HSA, Insulin (ELISA)
- Western blotting
- Isoelectric focusing, WCX
- Mass spectrometry
- Peptide Mapping
- Mono- and Oligosaccharide analysis
- (Bradford, BCA
- UV/Vis spectroscopy
- HPLC (SEC) and FPLC (Affinity, e.g. analytical Protein A measurement)
- Bioactivity assays
- Antigen ELISA
- Binding kinetics using DRX (Dynamic biosensors; substitution of Biacore SPR technology)
- Other specific binding assays: For more information please see our page “bioactivity and cellular assays”
- Ion chromatography