Issuing Body Agence nationale de sécurité du medicament et des produits de sante (ANSM)
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Eurofins ADME Bioanalyses is a leading CRO delivering integrated expertise in bioanalysis, in vivo studies, ADME, DMPK, biomarkers, immunogenicity and dermal projects. The company supports the development of small molecules and biologics across the entire drug development life cycle, providing high quality, regulatory compliant data to support confident, informed decision making.
Issuing Body Agence nationale de sécurité du medicament et des produits de sante (ANSM)
Issuing Body Country n.a.
Issuing Body Website https://ansm.sante.fr/documents/reference/bonnes-pratiques-de-laboratoire
Issuing Body Agence nationale de sécurité sanitaire de l’alimentation, de l’environnement et du travail (ANSES)
Issuing Body Country n.a.
Issuing Body Website https://www.anses.fr/fr/content/les-bonnes-pratiques-de-laboratoire-bpl
Issuing Body Comité Français d''Accréditation (COFRAC)
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Issuing Body Website https://www.cofrac.fr/nos-services/evaluer-les-bonnes-pratiques-de-laboratoire-bpl/
Issuing Body Autorité de sûreté nucléaire et de radioprotection (ASNR)
Issuing Body Country FR - France
Issuing Body Website https://reglementation-controle.asnr.fr/
Eurofins ADME BIOANALYSES is a Contract Research Organisation providing diverse services to the pharmaceutical industry in the fields of pharmacokinetics and drug metabolism.
Based at our site in the heart of Southern France we have over 2500m2 of laboratory and office space with a team of 100 FTE.
We have four business units which, working cooperatively between each other and in partnership with other Eurofins entities, can offer the full range of pre-clinical and clinical DMPK services.
Through regular, ongoing investments in equipment and staff training we target the optimisation of our client's registration timelines in the pharmaceutical, cosmetic or nutrition industries.
Eurofins ADME BIOANALYSES was founded originally as ADME BIOANALYSES in 1987 in Sophia Antipolis (near Nice) in France by Dr. Patrick Duchêne.
In 1999, the Company moved to new facilities in Vergèze, between Montpellier and Nîmes in France.
In 2005, the Company joined the Eurofins Scientific Group to expand its technological and geographical reach. This new organisation allowed the Company to strengthen its market position and to accelerate its development to provide ever increasing quality and range of technical services.
In 2013 and 2017, the Company increased its capacities with two consecutive extensions at the Vergèze site.
In 2018, following the retirement of the company founder, Dr. Tanja Schubert became the company CEO.
Eurofins ADME BIOANALYSES’ primary objective is to keep increasing its capacities and range of service offerings whilst remaining a gold standard partner for its clients.
It is in the early stages of development that reliable information is required with a quick response time and at a competitive price.
Eurofins ADME Bioanalyses offers a range of services in-house to aid in the decision making process from first “in-life” studies to compare products and formulations to in-vivo and in-vitro metabolism studies.
We have the capacity to manage studies on large, molecules, small molecules and ADC with all conventional and novel delivery systems.
Bioavailability assessment, Early exploratory PK in rodents, BBB permeation, tissue distribution, CSF, All phases in-house, Adaptable study design for lead selection, +3000 molecules already tested
14C/3H radiolabelled or cold compounds by LC-MS/MS Blood/plasma kinetics, PK analysis Excretion evaluation, Mass balance
Any biological matrix (fluids and tissues) Supporting screening, pre-clinical exploratory/safety and clinical studies Small molecules (LC-MS/MS) Method development, transfer and/or optimization
Diverse biological matrix (fluids and tissues) Supporting early, pre-clinical exploratory/safety and clinical studies Large molecules - ELISA / ECL (Mesoscale)
IVRT/IVPT for generic product development In vitro / In vivo application of topical products Franz diffusion cells, Bronaugh diffusion cells, PhoenixTM Dry Heat system
Pre-clinical development demands both GLP and non-GLP studies in-vivo and in-vitro.
Eurofins ADME Bioanalyses offers a range of bioanalytical services in-house with in-life phases in partnership with other Eurofins companies for toxicology, pharmacokinetic and pharmacological studies.
Method development and method validation for large and small molecules and ADC with over 30 years of experience. Both FDA and EMA guidelines.
14C/3H radiolabelled or cold compounds Blood/plasma kinetics, PK analysis Excretion evaluation, Mass balance
Any biological matrix (fluids and tissues) Supporting screening, pre-clinical exploratory/safety and clinical studies Small molecules (LC-MS/MS)
Study design Pre-clinical and clinical studies In-house method development (LCMSMS) and validation Calculation of PK parameters (WinonLin), bio-equivalence assessments
Pharmacokinetics, Toxicokinetics and systemic exposure All pre-clinical species In-house bioanalytical method development & validation Extrapolation to predict First-In-Man dosage GLP compliant
Diverse biological matrix (fluids and tissues) Supporting early, pre-clinical exploratory/safety and clinical studies Large molecules - ELISA / ECL (Mesoscale)
ADC (Antibody-Drug Conjugates) tADC and tMAB analysis by ELISA/ECL Payload analysis by LC-MS/MS
Immunoassays and assessment of potential immunogenicity Anti-vaccine antibody titres In-house development and validation (FDA and EMA Guidelines)
Study design Pre-clinical and clinical studies In-house method development and validation for Ab titres, ADA and NADA Calculation of PK parameters (WinonLin) GLP/GcLP compliant CDISC standards
Understanding biomarkers for better drug discovery and development Scientific expertise for biomarker selection (clinical fields, biological pathways, biofluids) Proteins
In vitro / In vivo application of topical products Franz diffusion cells, Bronaugh diffusion cells, PhoenixTM Dry Heat system
Exploratory Pharmacokinetics Small molecules/Large molecules/Biologicals Bioequivalence, all species (production and companion)
Phase I and Phase II studies require reliable, GLP compliant analyses with dependable turnaround times and seamless integration into dossier submissions
Eurofins ADME Bioanalyses offers state-of-the-art bioanalytical services to support clinical trials run by Eurofins own Phase I/II clinical trial centres or with a client’s own choice of clinical phase supplier.
Method development and method validation for large and small molecules, ADC and biomarkers with over 30 years of experience. Both FDA and EMA GcLP guidelines.
Since 1989, Eurofins ADME BIOANALYSES has been successfully inspected by
To contribute to the Health and Safety of all, by providing our customers with high quality services, offering our employees motivating careers and increasing the investment value of our shareholders.
on bioanalytical method validation and study sample analysis adopted by EMA in Jul 2022 and FDA in Nov 2022
August 2010
2019
February 2012
Guideline on validation of analytical procedures: definition and terminology
Guideline on validation of analytical procedures: methodology
VALIDATION OF ANALYTICAL METHODS USED IN RESIDUE DEPLETION STUDIES
May 2018
Developing and Validating Assays for Anti-Drug Antibody Detection - January 2019
July 2011
May 2017
May 2012
August 2010
February 2012
Guidance for industry and FDA, Dec 2018
April 2004
April 2004
August 2011
March 2004
SCCS/1358/10 - June 2010
15(6):4873
Assesment & Evaluation (parts B+C) Version 4.0 December 2017
October 2018
October 2022
October 2022
EMA/CHMP/QWP/608924/2014 - 23 October 2014
Product Development and Quality Considerations Guidance for Industry - November 2019
November 2019
12 LC-MS/MS SYSTEMS - API4000 (3), API5500 (2), Shimadzu 8060 (3), API6500 (2), API7500 (2)
Liquid Scintillation Counters - 14C and 3H Counting
HPLC Systems - With UV, fluorescence and diode array detection
HPLC - With online radiometric detection
Spectramax M3 & I3X Molecular Devices
Watson Bioanalytical LIMS 8.4
MESO QUICKPLEX SQ120 - Meso scale discovery
Sample storage at -20°C
Sample storage at -80°C
Franz Cells
PhoenixTM Dry Heat system
Bronaugh Cell
Orbitrap Exploris 120
Fujirebio Lumipulse G1200
Responsible for defining Eurofins ADME BIOANALYSES' short- and long-term strategies and leading the development of the company.
Responsible for managing laboratory and Test Facility operations.
Responsible for the Research and Development Unit, supervising the staff in the development and validation of bioanalytical methods.
Responsible for the operation of the DMPK Bioanalysis (Small Molecule) Unit.
Responsible for the operation of the Dermal absorption and In-vivo units.
Responsible for Biomarker Unit operations.
Responsible for the management of the Quality Assurance Unit and the QA programs and operations..
This year, our company achieved a good score of 82 out of a possible 85 points on the Gender Equality Index.
This result reflects our ongoing commitment to fostering a fair and inclusive working environment.
Although some indicators could not be calculated, the available data demonstrates a solid and consistent dynamic in terms of pay equality, career progression and representation. We will continue our efforts to further strengthen these achievements and maintain a high level of ambition in support of gender equality.
Difference in individual salary increase rates between men and women
Percentage of women benefiting from a salary increase following maternity leave
Number of employees of the underrepresented gender in the top 10 highest salaries
Salary gap by socio-professional category
Aiming to involve the staff in reducing waste and for better management of resources.
A combination of external partners and internal actions provide the opportunity to reduce, reuse and recycle. Diverse initiatives have already been put into place - paper shredders provided by a recycling company, fresh fruit and veg boxes supplied to participating staff every 2 weeks, better communication of the risks and benefits of being eco-responsible, encouraging good habits etc.
The aim is to promote the company values of engagement, sensitivity, and partnering to promote an intelligent consumption of resources. The group has the objective of introducing a rolling cycle of new ideas and staff-led initiatives in the months and years to come.
Environmental issues now occupy a major place in the collective consciousness of our societies with regard to the phenomena affecting our planet and their consequences for humanity: climate change, erosion of biodiversity, depletion of natural resources, degradation of natural environments, etc.
Faced with this situation, we all need to act, individually and collectively, to change our lifestyles and behaviour towards a more sustainable development model: "meeting the needs of the present without compromising the ability of future generations to meet their own needs" (Brundtland Report, 1987).
Aware that its activities have an impact on the environment, Eurofins ADME BIOANALYSES, operating in the field of health, must have a sustainable development policy that simultaneously reconciles economic growth, social equity and environmental protection.
This approach is now at the heart of its priorities and its growth strategy and is a guarantee of progress and shared growth, beneficial not only to the company, its employees, partners and suppliers but also to society in general.
Within this framework, a Charter has been drawn up which sets out the provisions and commitments made by the company to act in a sustainable and responsible manner on a daily basis in the deployment of its activities.
This Charter is based on three interdependent components: environmental, social and economic.
New initiatives will regularly be added to this Charter.