ABC Laboratories offers decades of experience in method development, bioassays and protein chemistry, a broad array of analytical techniques and laboratory instrumentation, and an unmatched commitment to client satisfaction.
Put Our Powerhouse of Biotech Veterans on Your Program
Our elite team of biotech veterans brings vast experience in academic research, pharmaceutical and CRO environments to your biopharmaceutical program. Having performed analyses on hundreds of different biomolecules, we're able to anticipate issues before they occur and quickly address development challenges. With ABC, you'll get more than data--you'll get direction. Learn more about members of our team.
Leverage ABC's Comprehensive Analytical Capabilities
ABC has more than 40 years of experience identifying, characterizing and quantifying chemical and biological test substances in a broad array of matrices. In addition to biotech heavy hitters, we offer you subject matter experts in just about every modern analytical technique and an impressive inventory of various chromatography, mass spectroscopy and specialty instruments.
ABC provides CGLP and CGMP analytical and product development services, including comprehensive characterization for protein and oligonucleotide biopharmaceutical products, as well as key analytical specific reagents (ASRs) for use in FDA-approved medical devices.
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
- Medical Devices
- Medical Intervention Products
- Vaccine Products
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
- 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.
- 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.
- Well-equipped, DEA-licensed laboratories with 35,000 cubic feet of ICH stability chamber space.
- Equipment:
- Chromatography Systems
- HPLC
- UPLC (binary and quad H class)
- CAD, Fluorescence, DAD, UV, RI and various MS detectors
- MALS & DLS by Wyatt
- Spectroscopic
- Electrophoresis
- Capillary Zone Electrophoresis (CZE)
- CIEF
- SDS-PAGE
- IEF-PAGE
- Western Blotting
- Mass Spectrometry
- MS
- LC-ES-MS/MS
- LC-Ion Trap/MS
- LC-ES-TOF-MS
- Immunoassays
- SpectraMax 5E Plate Reader for ELISA
- Electrochemiluminescence (ECL) by Meso Scale Discovery for ELISA