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Biotechnology Services
Services |
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Protein Characterization, Stability Analysis and Batch Release Testing
The Covance Biotechnology Services Division offers superior capabilities in all areas relating to protein characterization, stability and batch release testing. All of our facilities are operated in accordance with current GMP guidelines, with equipment being appropriately qualified.
Protein Characterization
The Protein Chemistry Group, with its state-of-the-art mass spectrometric, chromatographic and electrophoretic equipment, can provide a full range of GLP or GMP compliant physicochemical and biological techniques, adapted to each customer's needs and validated to satisfy the latest regulatory demands. The services offered by Covance to allow the characterization of protein structure and stability include:
- SDS-PAGE (reducing/non-reducing/native)
- A wide range of chromatographic techniques, including reverse phase, ion exchange, size exclusion and affinity chromatography
- Isoelectric focusing (IEF)
- Electrophoretic (Western) blotting
- Capillary electrophoresis (CE)
- UV-visible spectroscopy
- Fluorescence spectroscopy
- Amino acid analysis
- Electrospray mass spectrometry (ES-MS)
- MALDI-ToF mass spectrometry
- Peptide mapping (by LC or LC-ES MS)
- Extinction coefficient determination
- N-terminal sequencing
- Immunochemistry assays including ELISAs and radioimmunoassays.
Protein Stability
Using a subset of the analytical methods described under "Protein Characterization", Covance offers a wide range of stability testing, including short- and long-term and forced degradation (pH, oxidizing, temperature, etc.). Our data have been presented to regulatory bodies on numerous occasions, providing you assurance of their rigor. The quality parameters we have developed for our service in cell bank storage (stringent tolerance limits, calibration control, disaster recovery arrangements, etc.) carry over to our stability testing service as well.
The Protein Chemistry Group has in place Standard Operating Procedures to cover investigations resulting from Out of Specification events, providing our clients with the confidence that analytical data we provide can be replied upon. Stability is tested at various temperatures:
- -80°C
- -20°C
- +5°C (40% relative humidity)
- +25°C (60% relative humidity)
- +30°C (75% relative humidity)
- +40°C (75% relative humidity).
Batch Release Testing
Routine analysis of manufactured production lots is of critical importance to ensure consistency in material purity, identity and activity. The Protein Chemistry Group has significant experience in providing analytical support to supplement basic release testing typically performed within biomanufacturing facilities. We offer flexibility in data reporting to meet individual client needs. In this manner, certificate of analyses for individual production lots can serve as stand-alone testing documents for information purposes or alternatively, through a Qualified Person, can be incorporated into a single comprehensive batch release testing document.
Covance has in place the technical and Quality Assurance expertise to meet both the analytical demands and rapid turnaround necessitated by release testing. In addition, we pride ourselves in maintaining close communication between our clients, the manufacturing groups and associated Qualified Persons to ensure efficient management of these critical studies. |
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