Anapharm Bioanalytics has participated in the III Workshop on Phase I Clinical Trials

Bioanalytical Method Validation: Progress and New Challenges
By Araceli Castillo, Anapharm Bioanalytics

On May 21st, 2018, the US FDA published the definitive guidance for the validation of bioanalytical methods. The document includes the comments made on the 2013 draft and reflects the progress in science and technology for the past five years.
As compared to the previous draft guidance, the structure of this new document has been improved and summary tables have been added to point out the requirements and acceptance criteria for carrying out each one of the assays. Moreover, recommendations on the documentation to be reported were also included.
As main changes, we can emphasize that the development of the methods has gained importance. Also, the sections of chromatographic techniques and LBA have been unified. These two points make this guidance different from previous bioanalysis guidelines published to date.
On the other hand, within the current regulatory framework, bioanalytical laboratories must meet the requirements of different countries in order to offer a global service and facilitate the development of a drug at international level. However, the guidelines for the validation of bioanalytical methods published in the different regions show discrepancies, not only in the parameters required, but also in the procedures for their evaluation.
In 2016, ICH took the initiative to prepare a multidisciplinary guideline for the validation of bioanalytical methods, M10, to harmonize different requirements among countries. The draft guide is expected to be available for public consultation at the beginning of 2019.
The publication of the US FDA guidance in the midst of the ICH harmonization process changes the current scenario. How this will affect the ICH draft guideline currently being discussed is yet to be seen.


18/04/2023 16:38

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.

03/06/2022 12:39

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).

26/05/2022 11:39

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.