One of the strengths of Active Biotech is the close co-operation between the different specialities within the company leading to high flexibility and short lead-times. Active Biotech is currently engaged in several pharmacokinetic studies in animals and man, where our joint forces from formulation, chemical analysis and bioanalysis are managing the whole chain from formulation of a test compund to bioanalysis and metabolite identification.
Bioanalysis in pharmacokinetic studies of pharmaceutical compounds is performed at Active Biotech using LC-MS/MS technologies. The equipment includes mass spectrometers (Sciex API 3000 Series and Waters Quattro Ultima) with API interfaces.
Bioanalytical methods can be developed and validated in-house or transferred from clients. Optionally, synthesis of stable isotopes for use as quantitative internal standards can be performed.
We also offer metabolite identification in samples from plasma or urine using LC-MS/MS (Thermo Fisher LTQ XL). NMR analysis is also available for this type of work.
We have a fully equipped laboratory for analysis of radiolabeled and unlabeled pharmaceutical compounds and formulations thereof. Available techniques include NMR, MS and elementary analysis for identification. For quantitation and purity determinations, HPLC/UPLC, NMR and MS are used. For determination of radiochemical purity and specific activity, HPLC with flow scintillation detection and MS are used.
We can offer implementation of an existing method or development of new methods based on the requirements of the client. Method validation to an appropriate level according to ICH guidelines is also offered.
Stability studies of compounds and formulations can be performed in qualified environmental chambers. These chambers enables evaluation of product stability under long term and accelerated storage conditions controlling temperature and relative humidity.
Active Biotech can develop and manufacture formulations of pharmaceutical compounds for use in preclinical studies. Formulations for in-vivo use are normally suspensions or aqueous solutions but we also have experience of co-solvents, PEG's and cyclodextrins. Determination of physico-chemical characteristics (solubility, logP and pKa) are an integral part of the formulation development.