Anapharm Bioanalytics Brazilian ANVISA Certificate Renewal
Barcelona, July 09, 2018
Anapharm Bioanalytics is proud to announce that it has recently (11th June 2018) renewed its ANVISA (Brazil) certificate. The renewed certification is valid until 11th June 2020.
Anapharm has been certified by Brazilian regulatory authority since the first inspection took place in 2011. We have since then been assisting our European and Latin American customers achieve their goals in Brazilian market and will gladly continue providing high quality bioanalytical services in the coming years.
About Anapharm Bioanalytics
Over the past few years Anapharm Bioanalytics has established itself as a world class provider of bioanalytical services to international Sponsors with its strategically located, GLPcertified and GCP-compliant laboratory in Barcelona. With a wide experience and a successful regulatory history, Anapharm has become a stable analytical partner for its clients.
Anapharm Bioanalytics`s main strengths include strong expertise for method development and extensive portfolio of validated analytical methods, its high throughput capacity, as well as its top quality performance to deliver results within rigorous timelines at competitive prices.
For further details about Anapharm Bioanalytics, please visit https://www.anapharmbioanalytics.com/services/ or contact your Business Development representative at +34 93 223 8636
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