esolian's (formerly Alliance Pharma) bioanalytical team has extensive experience developing and validating robust LC-MS/MS methods for hundreds of compounds in various biological matrices (e.g. plasma, blood, urine, cerebrospinal fluid, and tissues) to support all phases of pre-clinical and clinical drug development. Our expertise spans a variety of compound types including conventional small molecules, peptides, large proteins and antibodies, antibody-drug conjugates, oligonucleotides, and trace metals. Our ability to consistently deliver timely and dependable results has earned us an excellent reputation dealing with unique and challenging bioanalytical methods and assays.
The bioanalytical team offers method development, method validation and sample analysis using state-of-the-art liquid chromatography and mass spectrometry (LC-MS/MS) and ICP-MS platforms. We conduct method validation and sample analysis in compliance with regulatory guidelines to support all stages of pharmaceutical development.
Our current offerings include:
- Rapid method development of fit-for-purpose methods
- Customized method qualification
- High throughput analysis to support discovery TK/PK/PD studies and in vitro assays
- Homogenization and analysis of tissues to assess drug distribution
- Biomarker analysis for pre-clinical pharmacology studies
IND Enabling and Clinical Support
- Method development
- Method transfer and optimization
- Full method validation per FDA/EMA/MHRA/ICH guidance
- Cross-validations with partner laboratories
- GLP sample analysis to support pre-clinical TK/PK studies
- GCP standard sample analysis to support all phases of clinical trials
- Clinical sample analysis to support bioequivalence studies
Technology Platforms & Techniques
We are capable of handling controlled substances (schedule 1 to 5), highly potent pharmaceutical compounds (OCH category 3 – 5), and radioactive materials. Additionally, we have a large sample storage facility to serve as your biorepository.
Seeking approval for your drug or device in China? Ask us about our partnerships that can facilitate transfer of your methods to our partner lab abroad.