Primarily made up of Eurofins ADME Bioanalysis, France.
Early and preclinical drug development is a complex, regulatory and strategy-driven process. The most important element of the preclinical process is to select the best new molecular entities to enter into the clinical trials and to limit failure in full development. Thus, the priority during the preclinical selection process lies in the safety and efficacy testing of a new molecular entity. With its countless years of professional experience in drug development Eurofins is well positioned to offer a holistic approach of the compound development in order to maximize the chances of success in the clinical phases.
Our network of expertise and full service is not only a matter of convenience but also an issue of confidence and security to succeed with your project. Our clients select Eurofins for this distinctive match of expertise, flexibility and full service. This beneficial setting explains why we work for 8 out of the 10 biggest Pharma companies.
Our areas of service include:
Biomarkers are distinctive biological characteristics which can be discovered and measured in parts of the body like the blood, serum or tissue.
They may be a sign of normal or diseased processes in the body. Biomarkers can be specific cells, molecules, or genes, gene products, enzymes, or hormones. Complex organ functions or general characteristic changes in biological structures can likewise serve as biomarkers. Although the term biomarker is relatively new, biomarkers have been used for a long time in pre-clinical research and clinical diagnosis.
For example, body temperature is a well-known biomarker for fever and blood pressure is used to determine the risk of stroke.
In the classical sense biomarker analysis comprises plasma, serum or tissue biomarker analysis on protein level, but more and more biomarker analysis on genetic/genomic level gain in importance. Eurofins Medigenomix focuses on analysis on the latter mentioned level and thus complements very well the services in the area of biomarker analysis of the other Eurofins companies, like Eurofins Global Central Laboratory.
In the field of biomarker analysis Eurofins Medigenomix offers a broad spectrum of services including genotyping, SNP and mutation analysis in genes which are relevant for pharmacogenetics / pharmacogenomics and for clinical diagnostics, as well as complete analysis of respective target genes or re-sequencing of individual areas of defined genes. Besides, the service portfolio includes expression analysis of single or groups of target genes and expression profiling on genome level with the goal to identify molecular signatures.
The past decade has witnessed a remarkable increase in the amount of small and large molecules developed for therapeutic use, especially therapeutic antibodies - a trend, which is predicted to continue. Cellular biomarker will be necessary in defining disease pathology, toxicological assessment and efficacy of these new drugs.
Flow cytometry is a powerful cellular analysis technique, which has proven to be valuable in research, clinical trial environment and further drug development.
Eurofins is well positioned to assist you with specialized flow cytometry assay development, validation, and sample analysis needs. We have developed five modular core assays that drug developers can use as they are or modify with additional markers to meet the needs of the specific clinical investigation.
The rapid-access of the "off the shelf" qualified panels provide: reduced cost, quick development time and flexibility to be validated according to the levels required by the study.
Our Immunoanalytics department operates multiple flow cytometry Canto II systems. Due to special needs for human material of clinical trials, we have developed a method to ensure equal results of one sample measured on two machines. This represents a perfect back-up system. Sample analysis is performed in compliance with G(C)LP.
As a leading innovator in flow cytometry supporting long-term clinical trials, we use molecules of equivalent soluble fluorochrome beads to enable the standardization of fluorescence intensity units irrespective of instrument and day of measurement. We are highly experienced in supporting worldwide clinical trials and in handling various samples from numerous clinical centers. Training of clinical sites by our flow cytometry experts ensures high quality samples.
Leader in bioanalytical services
Eurofins is a global leader for clinical and nonclinical bioanalysis. We are one of the largest bioanalytical CROs in terms of global presence, capacity, scientific expertise, number of different tests available and number of clients.
Our three bioanalytical facilities are located in the Netherlands, France, and in the US and operate more than 28 LC/MS/MS systems. At Eurofins Global Central Laboratory, Eurofins ADME Bioanalyses and Eurofins BioPharma Product Testing Munich we offer a premium service with an outstanding consulting activity. Our global bioanalytical group can respond to all of the complex analytical challenges encountered during nonclinical and clinical drug development. During the past year we have developed more than 450 methods with standard compounds and proprietary New Chemical Entities. These methods were developed for both small molecules and biologics. At Eurofins we take the time to understand our clients' study requirements. Our commitment to deliver the best service and our deep understanding of bioanalytical testing is the foundation for an honest and successful partnership with our clients.
One contact person and global, standardized processes
All of our bioanalytical facilities have installed WATSON to assure a uniform standard for our processes. One of the many reasons our clients keep returning to Eurofins' pharma services is that their projects are coordinated by a single contact person. Eurofins offers the flexibility of working with a small size company along with the stability and resources provided by a large harmonized organization. Our bioanalytical services include:
Highest Standards of Quality
Eurofins uses the same standardized methods, SOPs and bioanalytical experts to guarantee our clients the highest level of quality throughout the world. We are committed to the highest quality services and deliver accurate and timely results. Our laboratories are compliant to the following quality standards: ISO 15189 - ISO/IEC 17025 - OECD Principles of Good Laboratory Practice (OECD GLP), and Good Clinical Practice (GCP).
Eurofins ADME Bioanalyses have been successfully inspected by FDA in July 2009.
In cooperation with leading research groups Eurofins BioPharma Product Testing Munich has established several tests using different tissue culture models to quality control development of pharmaceuticals. This offers you the opportunity to investigate a variety of pharmacological aspects at considerably lower costs compared to clinical trials or animal studies. We offer a wide range of services from initial pharmacological screening to functional cellular assays accompanying clinical trials.
In vivo pharmacology studies are conducted by our partner BSL BIOSERVICE. Knowledge of pharmacodynamic and pharmacokinetic parameters is essential for the characterization of active substances. The primary screening of compounds for pharmacological and antimicrobial activities can assist in selecting candidate substances for further development. There is an increasing relevance on generating information on the pharmacokinetic and metabolic behaviour early during the developmental process. BSL BIOSERVICE provides a wide range of services to accelerate your candidate development from tailor-made proof-of-concept studies and early assessments of drug metabolism and pharmacokinetics to regulatory IND - enabling safety pharmacology studies.
For years Eurofins BioPharma Product Testing Munich has offered a broad scope of in vitro tests, thus establishing a fundamental pool of historical data. Many of our test systems (e.g. genotoxicity tests) meet the basic legislative requirements for the safety testing of new chemicals or drugs. Furthermore, we are well prepared to approach safety evaluation by applying economic screening versions that may help you to estimate the toxicological profile of your substances.
In the field of toxicology and pharmacology testing Eurofins works in close cooperation with different contract research organizations, Product Safety Labs and BSL BIOSERVICE.
For over 40 years Product Safety Labs (PSL) has been an industry leader in the conduct of acute, subchronic and chronic toxicity studies using various routes of administrations in different species. PSL prides itself on its commitment to quality, offering competitive pricing and on-time reports delivered through its team of expert, professional staff. Among the repeated dose toxicity studies we offer a comprehensive range of Developmental and Reproductive Toxicity testing ( DART), Neurotoxicology, Immunotoxicology, Ecological Toxicology, REACH and Endocrine Disruptor services. PSL also offers state-of-the-art capabilities for custom designed studies for product and discovery development/stewardship.
PSL conducts all studies in compliance with Good Laboratory Practices (GLP) for the safety evaluation of Pharmaceuticals, Food and Dietary Supplements, Agrochemicals and Industrial chemicals following OECD, ICH, U.S. EPA, FDA, EFSA, and JMAFF as well as other global testing guidelines.
BSL BIOSERVICE is an international active contract research organization, located in Munich, Germany. The company offers a broad range of biological safety testing services for (Bio-)Pharmaceuticals, Chemicals, Medical Devices, Agrochemicals, Cosmetics, and Food.
A high degree of customer orientation, high quality and flexibility are core values of BSL's corporate philosophy. A highly experienced team of scientists and regulatory experts guarantees acceptance by national and international authorities and supports customers from early research until finalization of preclinical studies.
BSL BIOSERVICE has been accredited with DIN EN ISO 17025 for biocompatibility testing of medical devices and has been certified in accordance with Good Laboratory Practice (GLP) and Good Manufacturing Practice (GMP). We are listed by the World Health Organization (WHO) and have successfully been audited by the FDA.
Complete preclinical service
Early and full drug development is regulatory-driven and complex. The priority in this selection process is to achieve the safety and efficacy of a new molecular entity. The preclinical activity includes mainly safety and pharmacological testing accompanied by metabolism, bioanalysis, biomarker development and pharmaceutical analysis. Eurofins offers the whole panel of GLP-assured safety studies and a broad range of pharmacological models including complementary activities such as ADME analysis. As preclinical activity is conducted throughout all phases of drug development, it needs to be well integrated in the regulatory-driven drug development strategy. Our clients benefit from our expertise in consultancy together with our flexibility and scientific excellence to test their compounds. This integrated approach is completely costumer tailored and differentiates Eurofins from many other CROs. We are making the difference and speed up the overall drug development process to achieve regulatory submission.
One stop shop or pick and mix approach
A comprehensive approach covers the stages from the assessment of the existing preclinical package to the creation and execution of a developmental plan to close the gaps of the project. We have the expertise, infrastructure and capacities within Eurofins to give you this inclusive support to reach your goals. Eurofins' pharma services provides both, the "one stop shop" and a pick and mix approach for screening or to complete a dossier with single studies.If you have not the appropriate expertise in house or if you are short in capacity, we can help you as your partner with an outstanding expertise in drug development.
The best service for your compounds
Eurofins ensures that your compound moves beyond preclinical regulatory requirements. Thus your project gets in the best position for proof-of-concept and large scale clinical trials. As we place the needs of our customers in first place, our approach is based on listening, consultancy and responsiveness. Altogether, we do not only deliver timely, accurate data but also a solution to your problem.
ADME studies are conducted to examine the absorption, distribution, metabolism, and excretion of new entities with either 14C or 3H molecules.
Eurofins ADME BIOANALYSES has experience on many different administration routes in single or multiple dosing.
For such projects, we can act either as study director or as principal investigator.
Eurofins Early Development has not received any reviews.
Eurofins Early Development has not received any endorsements.