Successful WHO Inspection
Anapharm Bioanalytics is proud to announce that it has successfully undergone World Health Organization GCP/GLP compliance inspection at its Barcelona based bioanalytical lab. The inspection was study-specific and WHO proved evidence that Anapharm’s practices are compliant with WHO Good Clinical Practice & Guidance for organizations performing in vivo bioequivalence studies. There were no observations during the inspection.
About Anapharm Bioanalytics
30+ years’ experience in LC-MS/Bioanalysis and 15+ years’ experience in LBA assays for antibodies and biomarkers, acknowledges Anapharm Bioanalytics as a world class provider of bioanalytical services to international Sponsors with its strategically located, GLP-certified and GCP-compliant laboratory in Barcelona.
With a successful regulatory history, having undergone +20 successful inspections from health agencies, including FDA (14 studies), GCP inspections from Austria, Italy and Spain (12 studies), as well as GLP certifications by EU authorities and ANVISA (Brazil), Anapharm has become a reliable analytical partner to support its clients at any stage of drug development from preclinical throughout all clinical stages Phase I-IV.
Challenges in development of robust analytical methods for the quantitation of low molecular weight compounds by LC-MS/MS
Method development can be considered one of the most challenging task in a Bioanalytical laboratory. When working with LC-MS/MS and low molecular weight drugs, low degree of ionization, poor fragmentation, higher presence of isobaric compounds or analyte loss due to their high volatility can get in the way of a successful method development.READ MORE
Qualification of a method for the measurement of a potentially therapeutic protein
A recent project completed by Anapharm involved qualifying an analytical method for the measurement of a therapeutic protein in human skin tissue. The protein of interest is one that is expressed ubiquitously in a number of tissues and cell types.READ MORE
Cell Lab | Anapharm Bioanalytics expands its laboratory capabilities
We are glad to inform you that a cell lab has recently been built at our facilities in Barcelona. Our brand new cell lab capabilities will enable the development and validation of a variety of assays such as Cell Proliferation, Ligand Stimulated Cell Signalling, Protein Secretion, Reporter Gene, NAbs, etc.READ MORE