Almac has the largest commercial cGMP and only GLP certified mass spec laboratory in Ireland
Robust and rapid LC-MS bioanalysis services are essential to pre-clinical and clinical programs, providing critical pharmacokinetic data to facilitate decision making at key stages of product development.
Our scientists are highly experienced in the development of high quality assays using state-of-the-art LC-MS/MS technology – Applied Biosystems API 3000/4000 instrumentation which incorporates the automated reporting of data. This specialist Analyst software is compliant with FDA 21 CFR Part 11.
We excel in the development and validation of routine and non-routine methods in a very wide range of matrices ( i.e. muscle, kidney liver, fat, bone, bone marrow, synovial fluid, cardiac tissue, plasma, serum, whole blood, urine and feces) and to apply these methods in a GLP and GCP compliant environment.
Impurities such as N-Nitrosodimethylamine (NDMA) have been highlighted by the US FDA, EMA and other regulatory authorities as an area for concern as they are probable human carcinogens. We have responded to regulatory guidance and offer laboratory drug testing to detect levels of NDMA and related impurities within our mass spectrometry laboratory. Our expert team have successfully performed testing on a number of APIs and Finished Products as per FDA method FY20-006-DPA-S_LCMSMS 10/17/2019 to establish levels of NDMA. Read our paper to find out more.
Our LC-MS/MS bioanalysis expertise includes:
- Chiral analysis
- Bioanalysis in multiple matrices
- Analysis of peptides and their metabolites
- API in ground water samples