Anapharm Bioanalytics Brazilian ANVISA Certificate Renewal
Barcelona, March 31st, 2020
Anapharm Bioanalytics is proud to announce that it has recently (February 20th, 2020) renewed its ANVISA (Brazil) certificate. The renewed certification is valid until February 20th, 2022.
Anapharm has been certified by Brazilian regulatory authority since the first inspection took place in 2011. We have since then been supporting our European and Latin American customers achieving their goals in Brazilian market and will gladly continue our mission of providing high-quality bioanalytical services in the coming years.
Should you have any project that might require our bioanalytical support, please do not hesitate to contact our Business Development team, at email@example.com.
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 the Detection of Metabolic Biomarkers Using a Multi Plex Assay
A 5 Plex method for the detection of metabolic biomarkers in human plasma was developed using the U-PLEX technology on the MSD platform.
The complexities surrounding this method were the establishment of endogenous QCs for each chosen biomarker and evaluating the potential use and need for buffer QCs vs matrix QCs where applicable. Additional challenges were faced while trying to ascertain a single minimum required dilution to enable accurate quantification of all biomarkers simultaneously, encompassing the different detection ranges and limits for each biomarker.READ MORE
Considerations to properly assess drug stability within biological samples
Assessing drug stability during method development and validation is of paramount importance. The concentration of the target analyte must remain unaffected throughout the lifecycle of the samples to ensure the reliability of the assay data. However, a decrease in analyte concentration in a biological fluid is not always due to a lack of stability.READ MORE
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