European Bioanalysis Forum
Encyclopedia
The European Bioanalysis Forum (EBF) is an organisation comprising bioanalytical scientists working within the pharmaceutical industry R&D. Scope of the EBF is on bioanalysis
of small and large molecules with bioanalysis being defined as:
Members discuss on regulatory issues and aspects (new guidelines, interpretation of existing guidelines) and present their joint opinion towards regulatory bodies and their peers. Further, they share common practices on procedures, science, Laboratory Information Management System
s (LIMS), validation, quality (GLP
) and discuss new developments in industry.
or presented at international meetings. As of May 2010 the EBF consists of 28 member companies.
, instrument providers and regulatory agencies. It is the intention of the organisation to inform their business partners and peers about the discussion held and agreements achieved and to open the forum for challenging procedures or techniques as well as for new regulatory requirements.
The EBF has also reached out to participate in international scientific meetings representing the bioanalytical voice of the European pharmaceutical industry. Selective examples are: American Association of Pharmaceutical Scientists meetings, The Boston Society Applied Pharmaceutical Analysis meetings, and Canadian Validation Group meeting.
s: drugs and biomarkers as well as immunogenicity
testing.
Bioanalysis
Bioanalysis is a sub-discipline of analytical chemistry covering the quantitative measurement of xenobiotics and biotics in biological systems.-Modern bioanalytical chemistry:Many scientific endeavors are dependent upon...
of small and large molecules with bioanalysis being defined as:
- Quantification of drugDrugA drug, broadly speaking, is any substance that, when absorbed into the body of a living organism, alters normal bodily function. There is no single, precise definition, as there are different meanings in drug control law, government regulations, medicine, and colloquial usage.In pharmacology, a...
s and metaboliteMetaboliteMetabolites are the intermediates and products of metabolism. The term metabolite is usually restricted to small molecules. A primary metabolite is directly involved in normal growth, development, and reproduction. Alcohol is an example of a primary metabolite produced in large-scale by industrial...
s in body fluids and tissuesTissue (biology)Tissue is a cellular organizational level intermediate between cells and a complete organism. A tissue is an ensemble of cells, not necessarily identical, but from the same origin, that together carry out a specific function. These are called tissues because of their identical functioning... - Quantification of PDPharmacodynamicsPharmacodynamics is the study of the biochemical and physiological effects of drugs on the body or on microorganisms or parasites within or on the body and the mechanisms of drug action and the relationship between drug concentration and effect...
and safety biomarkers amenable to conventional bioanalytical techniques - Bioanalytical characterization of NBEsBiopharmaceuticalBiopharmaceuticals are medical drugs produced using biotechnology. They include proteins , nucleic acids and living microorganisms like virus and bacteria where the virulence of viruses and bacteria is reduced by the process of attenuation, they can be used for therapeutic or in vivo diagnostic...
Members discuss on regulatory issues and aspects (new guidelines, interpretation of existing guidelines) and present their joint opinion towards regulatory bodies and their peers. Further, they share common practices on procedures, science, Laboratory Information Management System
Laboratory Information Management System
Sometimes known as a laboratory information system or laboratory management system , a laboratory information management system is a software-based laboratory and information management system that offers a set of key features that support a modern laboratory's operations...
s (LIMS), validation, quality (GLP
Good Laboratory Practice
In the experimental research arena, the phrase good laboratory practice or GLP specifically refers to a quality system of management controls for research laboratories and organizations to try to ensure the uniformity, consistency, reliability, reproducibility, quality, and integrity of chemical ...
) and discuss new developments in industry.
History
The EBF was founded in the fall of 2006 at the initiative of twelve pharmaceutical companies, all of them having bioanalytical laboratory activities in Europe. The goal of bringing these companies together was to implement a platform for discussions of science and regulatory issues. Views and recommendations following from these discussions are either published in scientific journals, like for example on the controversial and much debated topic of incurred sample reproducibilityReproducibility
Reproducibility is the ability of an experiment or study to be accurately reproduced, or replicated, by someone else working independently...
or presented at international meetings. As of May 2010 the EBF consists of 28 member companies.
Meetings
The EBF intends to stimulate further harmonization of industry practices in bioanalysis, to bring a common understanding of the interpretation of regulatory issues and more clarity to the implementation of procedures in order to achieve best practices in the world of bioanalysis. The forum currently hosts two types of meetings:Closed meetings
Twice a year the EBF brings together representatives all member companies to discuss subjects well prepared in advance. The topics range from procedural to regulatory often resulting in internal benchmarking or surveys. Next to these 'general' meetings, topic specific specialists meetings are also organized. All member companies assign one representative to these closed meetings.Open meetings
The EBF organizes annual symposia to involve the bioanalytical community: pharmaceutical industry, academia, CROContract research organization
A contract research organization, also called a clinical research organization, is a service organization that provides support to the pharmaceutical and biotechnology industries in the form of outsourced pharmaceutical research services...
, instrument providers and regulatory agencies. It is the intention of the organisation to inform their business partners and peers about the discussion held and agreements achieved and to open the forum for challenging procedures or techniques as well as for new regulatory requirements.
The EBF has also reached out to participate in international scientific meetings representing the bioanalytical voice of the European pharmaceutical industry. Selective examples are: American Association of Pharmaceutical Scientists meetings, The Boston Society Applied Pharmaceutical Analysis meetings, and Canadian Validation Group meeting.
Steering Committee
The organization is led by a steering committee elected from its members. The steering committee represents the EBF in international forums and sets the agenda for the closed and open meetings.Interest groups
An Interest Group Macromolecules (EBF-IGM) was founded in 2008 to provide a platform for scientific exchange and harmonization of specific aspects for the bioanalysis of macromoleculeMacromolecule
A macromolecule is a very large molecule commonly created by some form of polymerization. In biochemistry, the term is applied to the four conventional biopolymers , as well as non-polymeric molecules with large molecular mass such as macrocycles...
s: drugs and biomarkers as well as immunogenicity
Immunogenicity
Immunogenicity is the ability of a particular substance, such as an antigen or epitope, to provoke an immune response in the body of a human or animal.- Immunogenicity :The ability to induce humoral and/or cell-mediated immune responses....
testing.