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Biopharmaceutical Development
Services
General Services
- Recombinant proteins to include proteoglycans and other complex biomolecules
- Oligonucleotides to include siRNA, armored RNA and antisense DNA
- Antibody reagents and therapeutics
- Bulk and final products
- Vaccines
- Reference standard characterization
Bioassay Procedures
- Cell kill tests
- Cell-based bioassays
- Animal-based bioassays
- Proliferation tests
- ELISA
- Electrochemiluminescence (ECL) by Meso Scale Discovery
- RIA with NRC radiological license
- CGMP radiosynthesis for specialized reagents
Protein Chemistry
- AAA validation for quantitation and compositional analysis of proteins using Waters AccQ Tag precolumn derivitization and UPLC analysis
- Extinction Coefficient Determination by qAAA (AccQ Tag/UPLC) and UV 214 or 280
- Physiological UPLC-AAA using MassTrack® AAA Technology by Waters
- Peptide mapping by UV and /or LC-ES-TOF-MS to include proteoglycan analysis, disulfide mapping and reference standards comparison to detect degradation during stability testing. Degradant characterization by MS/MS or TOF-MS methodology. Protein sequencing by LC-ES-MS/MS stability testing with ICH-compliant chambers. Stability testing with ICH-compliant chambers.
Other Items of Interest
- LAL
- HCP
- 90,000 square feet of a pharmaceutical sciences building, inspected by the FDA in December 2011 to meet both GLP and CGMP criteria.
- Well-equipped, DEA-licensed laboratories with 35,000 cubic feet of ICH stability chamber space.
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