Anapharm Bioanalytics has been acredited under the Gulf Health Council
Barcelona, January 23, 2019
Anapharm Bioanalytics is proud to announce that it has been recently added to the List of Bioequivalence Centres Approved by GCC, Gulf Cooperation Council (United Arab Emirates, Bahrain, Kingdom of Saudi Arabia, Sultanate of Oman, Qatar, Kuwait and Republic of Yemen).
It will certainly enable Anapharm Bioanalytics to strengthen its commercial presence throughout the Gulf area. It will also ease the regulatory pathway to register a medicinal product under before mentioned Authority for any company who conducted the studies at Anapharm Bioanalytics.
About Anapharm Bioanalytics
30+ years’ experience in LC-MS/Bioanalysis and 10+ 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 19 successful inspections from health agencies, including FDA (6 studies), GCP inspections from Austria, Italy and Spain (10+ 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.
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 MORE
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 MORE
Challenges 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 MORE