New Bioanalytical assays and Certificates

Challenges in the Development of a Method for the Detection of Anti-PEGylated-aptamer Antibodies

03/06/2022

Immunogenicity assays capable of properly determining the presence of anti-drug antibodies (ADA) and anti-PEG antibodies have been recognized of great importance due to the fact that pre-existing anti-PEG antibodies could have an impact on the efficacy of a drug coupled to polyethylene glycol (PEG).

26/05/2022

The challenge of developing a new bioanalytical method considerably increases when two or more metabolites need to be simultaneously analysed. Their extraction and chromatography optimization can be further complicated if their physicochemical properties vary significantly. Method development may be even more difficult when low limits of quantitation are required, for instance, when evaluating the systemic adsorption of topical drugs.

07/04/2022

Anapharm Bioanalytics is proud to announce that it has recently renewed its ANVISA (Brazil) certification which is now valid until February 26th, 2024.

23/03/2022

Anapharm Bioanalytics’ small molecule division continues to expand its capabilities with the acquisition of a new LC-MS/MS equipment tailored for method development and validation of high sensitivity assays

28/02/2022

We are glad to announce that a new method has been successfully developed and validated for determination of Glycopyrronium and Indacaterol in human plasma by LC/MS/MS with a calibration range of 1-200 pg/mL and 2-250 pg/mL, respectively.

02/12/2021

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.

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.

14/06/2021

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.

04/06/2021

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.