ABC’s Biotech Development Services group has grown rapidly over the past several months – even faster than anticipated – and continues to expand its comprehensive support for large molecule development. Overall, ABC Laboratories expects the biotech group to grow as much as threefold in 2010.
John C. Anders, Ph.D., Director of Biotech Development Services, brings more than 30 years of experience in biopharmaceutical development from both the sponsor and CRO sides of the business. Over his distinguished career, Dr. Anders has held several leadership positions, building and leading advanced cGMP biotechnology analytical laboratories, and has expertise in time-tested and new technologies in protein chemistry, analytical methods, and analysis of macromolecules by various methods. He played a major role in developing a pipeline of seven genomic expression tests for diagnosis and risk assessment of various types of cancer, including the successful completion of a pre-IND application to the FDA and development of a clinical protocol.
Dr. Anders has assembled a team of biopharmaceutical experts, each with more than 18 years of experience in protein chemistry and chromatography.Learn more about the team here. To ensure the team is well equipped to meet client demand, ABC has invested in a leading-edge biotech lab housed in our new, 90,000 square-foot pharmaceutical development facility in Columbia, Missouri.
General Services
- Pre-IND immunoassay method optimization and validation
- Biomarker analytical development and validation
- IND and clinical bioanalytical support
- Method feasibility, development, validation and transfer
- ICH stability testing of bulk and finished products for IND/CTA/NDA submissions
- Biopharmaceutical product characterization
- Biopharmaceutical product testing
- Batch release testing
- Forced degradation studies
- CMC support for regulatory submissions
Specific Services
- Biopharmaceuticals
- 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
- Reference standard characterization
- Bioassay Procedures
- Cell kill tests
- Proliferation tests
- ELISA
- RIA with NRC radiological license
- cGMP radiosynthesis for specialized reagents
- Protein Chemistry
- AAA validation for quantitation and compositional analysis of proteins
- Extinction Coefficient Determination by qAAA and UV 214 or 280
- Peptide mapping by UV and /or LC-ES-TOF-MS to include proteoglycan analysis, disulfide mapping, comparison to reference standards 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.
- Safety Testing
- Resources
- 90,000 square feet of a pharmaceutical sciences building, inspected by the FDA in April 2010 to meet both GLP and cGMP criteria
- 43,000 cubic feet of ICH stability chamber space with DEA stability capability
- Equipment:
- Chromatography Systems
- HPLC
- UPLC (binary and quad H class)
- GC & GC/MS
- CAD, Fluorescence, DAD, UV, RI and various MS detectors
- MALS & DLS by Wyatt
- Spectroscopic
- Electrophoresis
- CIEF
- SDS-PAGE
- IEF-PAGE
- Western Blotting
- Mass Spectrometry
- GC-MS LC-ES-MS/MS
- LC-Ion Trap/MS
- LC-ES-TOF-MS