Isotopic Labelling Services
14C Radiolabelling Services:
• Custom synthesis of 14C-labelled compounds to support pre-clinical ADME studies
• GMP synthesis of 14C-labelled compounds for human AME studies
• Expertise and facilities for handling 14C-labelled gases and volatiles including 14CO2, 14CO, 14CH3I
Where possible we will recommend the synthesis of additional 14C-labelled late stage pre-clinical intermediates, which can be stored and used in subsequent GMP studies. This approach can avoid the need for a re-synthesis, saving both time and cost when providing labelled material for the hAME study.
Stable Isotopic labelling:
• Synthesis of stable-labelled compounds incorporating 2H, 13C, 15N or 18O
• Ability to perform H/D exchange on API or late stage intermediates
The use of stable labelled standards is recommended by EMA (Guideline on Bioanalytical method validation), AAPS/FDA (BMV Conference Report) and endorsed by the European Bioanalytical Forum and Global Bioanalytical Consortium. They provide increased speed, sensitivity, selectivity and robustness of LC-MS assays avoiding matrix effects, producing more reliable data.
Additional Experience and Services:
• Ability to safely handle high potency / high hazard compounds (cytotoxics)
• Synthesis of metabolites & reference materials aiding Bioanalytical and Metabolism studies
• Degradants and process impurities to support API development,
• GTI assessment of confirmed impurity / degradant structures found during the scientific evaluation of investigational drug substances and products, to comply with ICH M7 guidance.
• Route development and precursor synthesis for labelling with 3H and short lived isotopes 11C and 18F
• Experienced in classical and non classical synthetic techniques, microwaves, H/D-cubes, automated peptide synthesis, microbiological and bio-catalysis.
SMi Highly Potent Active Pharmaceutical IngredientsThe SMi Highly Potent Active Pharmaceutical Ingredients Conference will be attended by Mark Anstiss, Scale-up Chemist.
SMi Highly Potent Active Pharmaceutical IngredientsDates: 21st - 22nd MayLocation: Birmingham, UK
66th Annual ASMS ConferenceThe 66th ASMS Conference on Mass Spectrometry and Allied Topics Conference will be attended by Michael Blackburn, Method Development Scientist (Physiochemical). Michael will also be presenting during the conference, at the Proteins & Peptides Waters Users Meeting, with a presentation entitled; A Powerful Hybrid IA-LC-MS/MS Method Quantification of Insulin Analogues and
66th Annual ASMS ConferenceDates: 3rd - 7th JuneLocation: San Diego, US
2018 BIO International ConventionThe 2018 BIO International Convention will be attended by Mark Chadwick, Head of Business Development.
2018 BIO International ConventionDates: 4th - 7th JuneLocation: Boston, USA