We recognize that you face different bioanalytical challenges in discovery, preclinical, and clinical development, and we have implemented tiered method development as standard policy. To start, we can build a low cost screening method suitable for 3 compounds and then run 30 rat plasmas per compound, with results turned around in 2 days. Then as the lead compound is selected, we can build a qualified preclinical method for early preclinical trials. Ultimately these methods can be validated to regulatory guidelines to support your safety and efficacy claims.
AIT Bioscience LC-MS/MS Capabilities
- Method development — whether you just have powder or a basic method, we can work out the kinks
- Non-GLP discovery analyses — getting good results fast, for internal use
- Method validation consistent with EMEA and FDA guidances
- Method transfer capabilities — cloning your method to our lab without change, regardless of LC-MS platform in your lab
- High throughput regulated sample analyses for preclinical and clinical studies
Our Platform Speeds Delivery of Final QA’d Results
Consider the workflows in a typical bioanalytical laboratory. A study is built in Watson and divided into sample analysis runs. Each Watson run generates a worklist to be sent to the mass spectrometry software, such as Sciex Analyst. Data files are acquired on local or network drives. The raw data is extracted to spreadsheets and returned to Watson for regression and reporting. At the end of the study, raw files are gathered, wherever they may reside, and then archived. This is a messy process, with multiple software operations and several Part 11 gaps.
In contrast, our processes are simpler, because we chose Thermo triple quad systems, based on performance, comparative results, and an attractive integration with Watson LIMS. Watson uses its included TSQ Module to replace previously separated instrument data acquisition and control software. Watson controls the instruments, acquires the data, integrates the runs, and tabulates the results, all inside an Oracle database. Data files are not left on drives but live as elements of an Oracle database. All of the metadata related to data acquisition and processing are held in Oracle.
From a regulatory standpoint, every step is audit-trailed, since the entire process is conducted inside a “closed system.” Peaks are integrated in Watson, not Analyst. The software further enforces a final review of the integrations before any regression can be performed. Integrations are irrevocable once the user moves to regress the data.
Each LC-MS/MS system is designed for fast UHPLC separations enabling 1-3 minute cycle times with resolution better than conventional columns.
- Thermo Vantage LC-MS/MS Instruments (4)
- Thermo Quantiva LC-MS/MS Instruments (3)
- Waters Acquity UPLC Systems
- Thermo UHPLC Systems
- Thermo Velos Ion Trap LC-MS/MS Instrument
- Hamilton Star Liquid Handling System
- Tomtec Quadra 96 Workstations
- IDBS Electronic Laboratory Notebook System (ELN) interfacing with Watson™ 7.4 with TSQ Module™
ELN Linked to Watson
AIT Bioscience recognized that ELN could automate many calculations and checks performed manually on spreadsheets. Consider the collective time spent in our industry building spreadsheets and then having 2 more reviewers check them for accuracy. We built “hooks” between ELN and Watson to replace these manual checks. For example, recovery, matrix factor, selectivity, carryover, and stability results are pulled from Watson and calculated in ELN with single mouse clicks, all while minimizing potential for errors.
Protein Methods based on Mass Spectrometry
AIT Bioscience collaborated with Perfinity Biosciences to investigate the use of automated protein processing to transform protein analysis in biological fluids. The Perfinity WorkStation includes immunoaffinity cleanup, high activity immobilized trypsin digestion, and gradient elution LC-MS/MS or ion trap detection. Regular and microflowrate systems have been used to assay proteins up to 150KD in plasma with little sample cleanup. Detection limits without immunoaffinity cleanup are ~200-500 ng/mL.
- MAb quantitation in preclinical trials without waiting for immunoassay reagents
- Profiling PTM’s in biosimilars
- Immunoaffinity option for selective cleanups prior to trypsin conversion
- Micro flowrate LC for higher sensitivity MS detection.
Competitive advantages for our Sponsors
In addition to rapid data turnaround times, other benefits include:
- Minimum batch fee (for only sample counts less than 50 samples)
- No report fees – if in AITB format
- Typically, no ALQ repeat fees
- No sample storage fees (for one year at -20C)
- Fixed and competitive pricing
- Unparalleled audit trails
For more information about AIT bioanalytical processes, contact us by email or phone at 317-715-8800.