04/07/2022
Anapharm 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.
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 contact@anapharmbioanalytics.com.
About Anapharm Bioanalytics
30+ years’ experience in LC-MS/MS Bioanalysis and 15+ years’ experience in LBA assays for biologics, 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 22 successful inspections from health agencies, including FDA (14 studies), WHO GCP/GLP compliance, 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 worldwide at any stage of drug development from preclinical throughout all clinical stages Phase I-IV.
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Anapharm Bioanalytics Secures Funding from Eurostars and CDTI for Innovative Project on Therapy and Diagnosis of Ewing Sarcoma
Barcelona, April 18th, 2023 – Anapharm Bioanalytics, a leading bioanalytical contract research organization (CRO), is delighted to announce the successful acquisition of funding from the Eurostars-3 joint program, with co-funding from CDTI (Centre for Industrial Technological Development) and the European Union’s Horizon Europe Research and Innovation Framework. This funding marks a significant milestone for the groundbreaking project, a collaborative effort between Anapharm Bioanalytics, iCellate Medical, and Aptadel Therapeutics.
READ MOREChallenges 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.
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