03/03/2016
Anapharm Europe Brazilian ANVISA Certificate Renewal
Anapharm Europe is proud to announce that it has recently renewed its ANVISA (Brazil) certificate. The renewed certification is valid until 22nd February 2018. 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.
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Challenges in the Development of a Method for the Detection of Anti-PEGylated-aptamer Antibodies
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).
READ MOREChallenges in the determination of two analytes with different physicochemical properties, Tapinarof and its main metabolite, Tapinarof Sulfate, at the low picogram level
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.
READ MOREAnapharm Bioanalytics Brazilian ANVISA Certificate Renewal
Anapharm Bioanalytics is proud to announce that it has recently renewed its ANVISA (Brazil) certification which is now valid until February 26th, 2024.
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