Cifga Laboratoy is a chemical pharmaceutical SME located in Lugo, Spain. It was born as a spin-off in 2006, and its business model is based in the profits of marine toxins, specifically taken in account 2 basic applications:
Contamination of shellfish by marine toxins has become a global and increasing problem. The current European legislation requires monitoring programs so to place bans on shellfish that contain toxin levels above the regulatory ones. In last years, several initiatives have been focused in the development of methods of control that do not require the use of animals, not only because of ethical issues related to the pain and suffering, but also the suitability for all group of toxins, and the advances and efforts regarding scientific methodology for detection and determination.
Marine toxins standards
Standards are materials containing a known concentration of an analyte, so they provide a reference to determine unknown concentrations. These products are used for a range of functions within measurement processes, including calibration, method development and validation, metrological traceability and quality control purposes, specifically related to seafood safety monitoring, but the availability of toxin standards has always been a major problem, because of their scarcity, and difficulty to obtain them, so very few groups spend efforts in their obtaining.
In this way, Laboratorio CIFGA S.A. has worked hard to get different certified marine toxins standards, following ISO Guide Series 30, including ISO Guide 34 required for producers of reference materials, and it has become the first company in Europe able to provide certified reference materials (CRMs) of marine biotoxins.
Therefore CIFGA has a large inventory of resources to produce organisms (specifically microalgae) and then identify, isolate and purify the compounds of interest. The research and the knowhow acquired allow the application of the technology to different analysis, such as other toxins (mycotoxins), antibiotics, drugs, pesticides, vitamins, aminoacids, lipids…. So although the main core of CIFGA is the development of standards, we also provide analysis of biotoxins and compounds; develop specific analytical methodology; personalized consulting; analytical training and R&D projects.
Certified Reference Materials developed by CIFGA are in agreement with the processes and requirements established in ISO Guide 34. The certification of reference materials follows strict rules which are described in ISO Guide series 30-35, therefore the products obtained are:
Traceable: The method used for quantification is quantitative NMR spectroscopy (qNMR). It is considered a method with metrological unique capabilities, since the NMR signal intensity is directly related to the numbers of protons that contribute to the signal. For calibration and direct comparison NIST Standard Reference Materials are used.
Precise: Detailed studies of individual errors are carried out to define the overall uncertainty for each CRM, providing an exact value for each batch of material.
Pure: On average, our products posses a purity ≥95 %. This is assured by using different analytical methods for the identification, characterization and quality control of our products (UPLC, UV, FLD, MS, NMR). Quality specifications are predefined and all the steps needed to comply with them are performed.
Accurate: Products are quantified by validated qNMR methods developed on Innova 750 MHz and Varian 500 MHz spectrometers, which lead to an accurate result. In addition, qNMR and UPLC-MS/MS conjunction allows performing reliable products.
Homogeneous & Stable: The necessary studies are conducted to verify that the samples analyzed are in the same value within the same unit and among all units of the batch. Moreover, subsequent studies are performed to ensure that their properties remain throughout the certification process, and are continued over time to maintain that certification.
Documentation: Each CRM is accompanied by a certificate of analysis that follows ISO Guide 31 guidelines.