Synchron bioanalytical team offers method development, assay validation and specimen analysis using state-of-the-art liquid chromatography and mass spectrometry (LC-MS/MS). We perform method validation and sample analysis in compliance with regulatory guidelines to support pharmaceutical development.Methods are developed and validated in accordance with either client-specific protocols or internal SOPs and all methods are validated to meet MHRA, FDA and/or EMA guidelines. We are capable of handling both controlled substances and radioactive materials. Bioanalytical has a dedicated sample tracking and sample management team. The sample management team carefully inspects each shipment against the study protocol requirements to ensure sample integrity and traceability. A list of our current offerings is as follows:
- Method transfer and optimization
- Method development and validation
- Analytical support for clinical trials
- Pharmacokinetic (PK) studies
- Bioequivalence studies
- Bioanalysis of chiral compounds and endogenous compounds
Bioanalytical Equipment List:
- Shimadzu- 8050 with Nexera (1)
- Shimadzu- 8040 with Nexera (4)
- Waters Acquity UPLC with Quattro Premier (2) and premier XE (1)
- Waters Alliance 2695 with Quattro Micro (1)
- Thermo TSQ Quantum Ultra with CTC Pal and Accela Pump (1)
- N2 Fast, TurboVap LV Evaporator (1)
- Rapid 50 Evaporator (2)
- Nitrovapcon Evaporator (2)
- Sartorius Balance – CPA-225D (2)
- Sartorius Balance – ME-5(1)
- Sartorius Balance- CUBIS MSA 3.6 P
- Thermo Scientific Cooling centrifuge Legend XTR (2)
- Remi Cooling Centrifuge CPR-30 (2)
- Sanyo -70/80 °C Upright Freezer (1)
- Haier -70/80°C Upright Freezer (1)
- Thermo -70/80°C Upright Freezer (3)
- Thermo -20°C Upright Freezer (2)
- Remi -20°C freezer (2)
- Remi -20°C Upright Freezer (1)
- Blue Star -20°C walk in freezers
- Eurotherm temperature monitoring and alarm system for all freezers, refrigerators and selected ambient zones with remote notification capability (1)
- 24-hour card controlled facility access
- Incremental data backup and full backups on project completion
- UPS power supply protection for all LC-MS/MS systems
- DG set power backup for freezer room