Vivotecnia toxicology and safety labs were founded in 2000 and is a fully independent European Toxicology Safety Contract Research Organisation (CRO) with the Headquarters based in Madrid, Spain.
We offer services to support the preclinical development of biotechnology and pharmaceutical products as well as safety studies for cosmetic, chemical and agro-chemical companies.
Performance and delivery are further enhanced by our design and implementation of state of the art information technologies. Access to electronic SOPs, an incremental improvement management system, as well a Part 11 compliant Provantis® data acquisition system, have been established to increase efficiency and quality deliverables.
Our animal units hold rodents, dogs, rabbits, minipigs and non-human primates.
Working with Vivotecnia provides a partner. Our highly qualified study management team, with longest experience from both within the CRO and pharmaceutical industries, understand the challenges you face and are committed to providing knowledge, advice and the high quality service that you expect.
Our aim is to help you achieve your goals regardless of the magnitude of the challenge you may face. We take an innovative approach to study design to ensure that your study is performed optimally, cost effectively, ethically and will meet all regulatory requirements.
Our client list includes regular repeat business customers from Spain, Europe, Central America, Japan, Korea and USA. We look forward to have you joining our increasing number of satisfied customers.
Our team of experienced, highly-educated scientists, with backgrounds in toxicology, molecular biology, chemistry and immunology, understand that the drug development process is no longer a one-size fits all approach. Every development programme is different so we work with you to develop a strategy to ensure that your studies are performed to the highest quality standard and will meet the required international regulatory requirements (EMEA, FDA, OECD, ICH).
Vivotecnia facility is fully GLP accredited and conducts all studies to GLP standard whether monitored or non-monitored by Quality Assurance. We selected Instem’s Provantis™ platform for rapid and accurate data capture.
Our internal processes have been developed to ensure maximum efficiency to ensure you receive your high quality report in a competitive timeframe. We also offer fast, reliable, conveniently tailored in-vivo screening studies that address your discover needs.
Genotoxicity tests can be defined as in vitro and in vivo tests designed to detect compounds which induce genetic damage directly or indirectly by various mechanisms. The genotoxic substances induce damage to the genetic material in the cells through interactions with the DNA sequence and structure. This damage is generally considered to be essential for heritable effects and in the multi-step process of carcinogenicity.
A standard battery of genotoxicity studies is required by regulatory agencies prior to the authorization of phase I trials with a new drug. The analysis of all these results helps evaluate the potential risk of carcinogenicity due to DNA damaging mechanisms. The standard battery for genotoxicity includes the assessment of mutagenicity in a bacterial reverse gene mutation test (Ames test), since these assays have been shown to detect relevant genetic changes and the majority of genotoxic rodent and human carcinogens. Furthemore the Ames test is also used worldwide as an initial screen to determine the mutagenic potential of new chemicals and drugs.
Vivotecnia offers the following studies for the analysis of genotoxicity:
Safety Pharmacology satisfies a key requirement in the process of a drug development, assessing the potential adverse effects of drug candidates on the major physiological systems of the body. A core battery of Safety Pharmacology tests are required by international regulatory guidelines (ICH S7A/S7B) prior to initiation of the first human dose of an investigational medicine, including cardiovascular function, respiratory function, and CNS behavior.
Typically a core battery of Safety Pharmacology includes:
Vivotecnia is always involved in a continuous trend of improvements, striving to provide its customers with the best performance at competitive prices. Following this philosophy, Vivotecnia has further expanded its safety pharma portfolio and has added to its established Irwin test, the cardiovascular safety assessment in conscious telemetry-implanted animals. The telemetry system allows the animals to move freely while monitoring and collecting all data.
In addition to the three main vital systems (Central Nervous, Cardiovascular and Respiratory Systems), the effects of a test substance on other important physiological functions should be assessed on the basis of its known chemistry, PK/PD or previously reported preclinical or clinical effects: i.e. Gastrointestinal (intestinal and colonic transit, gastric emptying, gastric acid secretion, …) and Renal & Urogenital (diuresis and urinary electrolytes excretion, main urinary parameters, bladder activity…).
Inhalation toxicity studies are required to assess the exposure hazards for consumer products or manufacturing workers.
In accordance with the requeriments of OECD guidelines for testing of chemicals, inhalation studies are designed “to satisfy hazard classification and labeling requirements, to estimate the toxicity of mixtures, and to assess human health and environmental risk”. “Acute inhalation toxicity studies can also charactize hazards associated with end-user products (e.g. biocides used indoors, multipurpose spray cans, aerosolized cleansing agents, incense to repel insects)”.
“Repeated exposure inhalation toxicity data are used to satisfy hazard characterization requirements with focus on a NOAEL”. “Therefore, in these types of studies, the primary focus is not on the classification and labeling of substances/mixtures as being commercialized but rather on characterization of toxic mechanisms and exposure atmospheres causing health hazards to repeatedly exposed humans”.
Our services ensure the compliance with OECD guidelines for acute inhalation as well as repeated administration through inhalation route.
In addition, inhalation route is an active area for pharmaceuticals drug development. Therefore, inhalation toxicity studies are aimed at potential inhaled therapeutics products.
In the process of drug development, pharmaceuticals are routinely tested for safety and efficacy before they
are being marketed. Within this process, carcinogenicity studies are required by the regulatory authorities for
those pharmaceuticals which are intended to be administered continuously or intermittently over a prolonged
period, in addition to compounds with a mutagenic potential or a structural alert indicating a putative
carcinogenic effect, or influence on cell proliferation have to be tested, even if it is intended for a short period
According to the regulatory agencies, the potential for a compound to cause cancer should be assessed with
a two year rodent bioassay in addition to an additional in vivo test for carcinogenicity (Long-term
carcinogenicity study in a second rodent species or short or medium-term in vivo rodent test systems)
Together with in our partners, we provide these testing strategies in compliance with the international
regulations, to identify the tumorigenic potential of your compound in animals and to assess the relevant risk
in humans for regulatory purposes.
Vivotecnia can offer you customized early Non-GLP toxicology in vivo studies to support comparison and selection of your potential lead candidates and drive the design of . Although these early studies are not required to be reported to the regularory agencies prior to First Time In Human studies, we understand that toxicology needs to be fully integrated into the discovery process to allow the selection of candidates with the optimal toxicological properties, making informed decisions quickly , at reduced cost.
Vivotecnia offers exploratory estudies od compounds administered by a wide range of routes and animals species includinf rodents, rabbits, dogs, minipigs and NHP.
The in vivo nude mouse xenograft model is a useful tool to investigate the events involved in cell malignant transformation, invasion and metastasis, as well as to evaluate the efficacy and/or mechanisms underlying therapeutic approaches. Vivotecnia hold a range of cell lines from breast, colorectal, brain, connective tissue, lung, skin, bone, pancreas and muscle available for establishment (cell dose/animal, vehicle, volume of administration etc to define the tumour volume growth post-cell inoculation).
Additional efficacy models available include:
We are experienced in developing new efficacy models. We will be pleased to evaluate how we can help you in your research project.
Our in-house team of veterinarians ensure that animal welfare is paramount and are committed to the principals of the 3Rs (refinement, reduction, replacement). Our ethical review process ensures that studies are performed with a sound scientific background, using an appropriate number of animals, and operating in strict accordance with EU regulations.
Utilising the expert advice of individuals from within the CRO industry with long experience with non-human primates, we designed our state of the art non-human primate unit. Extensive training of our study directors and animal technicians followed.
We can therefore provide an alternative second non-rodent species where dog is not deemed an appropriate species (receptor binding information, metabolism differences or lack of systemic exposure relative to expected human therapeutic exposure, etc).
State of the art gang housing exceeding the standard welfare regulations:
Vivotecnia offers mini AMES test as a pre-screening miniaturized version of the standard Salmonella reverse mutation assay (Ames test, OEDC 471). The mini Ames enables to perform a preliminary screning of the mutagenic potential of pharmaceuticals, agrochemicals, chemicals and cosmetics minimizing the usage of the test compound.
The mini Amest test offered by Vivotecnia uses the same bacterial strains, the same test principle and quality control specifically referred to in OECD Guideline 471, REACH and ICH guideline M7.
Mini Ames test is performed using two Salmonella strains: TA98 (frameshift mutation) and TA100 (base-pair substitutions). Both strains carry a defective (mutant) gene which prevents the bacterium from synthesizing the amino acid histidine unless mutations occur in certain genes. TA 98 and TA100 strains are the two most sensitive S. typhimurium strains for the detection of frame shift (TA98) and base-pair substitution (TA100). Other strains may be included upon request.
The assay is performed either in presence and absence of a metabolising system (eg, rat liver S9 fraction induced by Aroclor 1254). This approach enables to evaluate the mutagenic potential of the test compound as well as its metabolites.
In accordance with the requirements of ICH M3 guideline on Guideline on Nonclinical Safety Studies for the Conduct of Human Clinical Trials and Marketing Authorization for Pharmaceuticals, evaluation of developmental and reproductive toxicology (DART) endpoints is a fundamental part of the non clinical safety assessment program for compounds with potential use for women of childbearing age or who might be exposed to them during pregnancy.
Our testing solutions ensure the practical implementation of ICH S5 (R2) guideline on Developmental and Reproductive Toxicity Testing for Pharmaceuticals and adequate study designs needed for registration of new medicinal products in member countries (European Union, Japan and the United States). You can rely on Vivotecnia to deliver timely nonclinical reproductive toxicology programs meeting your product development goals and facilitating your product registration.
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