Bioanalytical Lab Capabilities

Team & Experience

Well trained scientists with over 30 years of experience in bioanalysis offer all necessary support to our clients at any stage of drug development.

Since its foundation, Anapharm Bioanalytics’ philosophy has been to recruit highly qualified personnel with emphasis in appropriate training to ensure an optimal level of scientific expertise and high quality standards in all studies.

Over the past years Anapharm Bioanalytics has established itself as a world-class provider of bioanalytical services to international sponsors, an achievement which gives us great satisfaction.

Laboratory management has been working in the bioanalytical industry since the 1980’s and has earned a strong international reputation. The majority of our senior staff holds a PhD, a Master’s Degree or a Bachelor’s degree in Chemistry and 10 to 15 years of proven bench experience.

The bioanalytical team is headed by the Laboratory Director, a Deputy Laboratory Director and a Bioanalytical Coordinator. They lead a team of Study Directors and laboratory personnel; all of them are highly trained in all facets of analytical work including sample handling, sample extraction, run set-up and data processing.

The combination of our staff's versatility, flexibility and solid scientific knowledge allows us to distribute work in order to adequately adapt to each study’s requirements. To ensure a smooth project flow and in accordance with GLP each study has an assigned Study Director in charge, who leads an analytical team dedicated to your project. We ensure direct and easy communication with the Study Director throughout the project in order to meet your individual requirements and provide you fast assistance and timely updates.

Our relationship with our clients is essential to us; we want you to feel confident with our work!

Facilities, Equipment & Software

Anapharm Bioanalytics offers substantial capacity and expertise in high performance liquid chromatography mass spectrometry (LC-MS/MS) and Ligand Binding Assays (LBA) tailored to provide accurate results throughout all phase of pharmaceutical development.

Our GLP-certified, FDA-inspected, GCP-compliant and ANVISA-certified laboratory is equipped with best-in-class instrumentation and software including the following:

• 1,500 m2 of laboratory space with controlled access

• Laboratory Information Management System (LIMS)

• 14 LC-MS/MS platforms:

• 4 x Sciex Qtrap 6500/UPLC

• 2 x Sciex Qtrap 5500/UPLC

• 2x Sciex API 5000/UPLC

• 6 x Sciex API 4000/HPLC

• MSD – Meso QuickPlex SQ120 - ECL Tech

• Enzyme Linked Immunosorbent Assay (ELISA) with the following readouts:

• Colorimetric

• Chemiluminescence

• Fluorescence

• Precellys Evolution Homogenizer.

• 4ºC, -20ºC and -80ºC refrigerators and freezers which are monitored 24/7. Large storage capacity (300,000+ samples) and reliable sample tracking.

• On-site archives with restricted access, environmentally controlled and protected by automatic oxygen-displacing fire extinguisher systems.

• Robotics sample handling and extraction technology from TOMTEC.

• Multi-purpose laboratory for special projects such as light sensitive samples.

• Reference standards room with restricted access.

• Emergency electrical supply for freezers.

• Two Uninterrupted Power Supply units (UPS).

Quality Assurance

Quality is of utmost importance at Anapharm Bioanalytics. All analytical work and processes are conducted in accordance with Standard Operating Procedures (SOP) in strict compliance with Good Laboratory Practices (GLP), Good Clinical Practices (GCP) and are constantly updated to comply with international regulations.

The Quality Assurance Unit (QAU) at Anapharm Bioanalytics is led by a Director with over 20 years of experience in the field. The unit ensures strict compliance with applicable guidelines, integrity of study data by continuous monitoring, process improvement and staff training.

The QAU is an integral component of every study, and systematically monitors each one from analytical protocol and method validation, through experimental work in sample analysis, data management and final analytical report. In addition the QAU conducts process-based and facility audits.

The continuous inspections undertaken by Health Agencies as well as audits from pharmaceutical companies, together with the endeavours of our staff contribute to the constant improvement of quality, integrity and compliance at Anapharm Bioanalytics.

Our clients also benefit from regulatory support during dossier registration. In order to ensure smooth marketing authorization, assistance is provided to answer queries and letters of deficiency issued by Regulatory Authorities worldwide during the drug approval procedure.