Newsletter, septembre 2014

Citoxlab now brings Next Generation Sequencing to your development program

Bulles emailing sept 5Citoxlab is pleased to announce the addition of the Next Generation Sequencing technology (NGS, Illumina®) into its existing genomics platform.

Recent developments in technology made the NGS a powerful tool to deeply investigate signalling pathways. NGS has been used in the last few years to identify relevant therapeutic and diagnostic biomarkers in many areas such as oncology, CNS disorders, etc.

With the implementation of the Illumina® technology, new services will be available for whole genome, RNA and miRNA sequencing, bringing a deeper analytical power to your molecular investigations.

Over the last 10 years, Citoxlab has been a service provider of gene chips (Affymetrix accredited Service-provider). More recently, our team has set-up and validated new methods for miRNA biomarker quantification in preclinical and clinical study samples.

The NGS service will complement our existing gene chips and q-PCR based platforms and make Citoxlab a one-stop shop CRO in this domain.

Discover a Broader Range of Cardiac Safety Testing Models

Bulles_souris_mouseOur team is happy to announce the availability of new models of high definition telemetry for left ventricular pressure (LVP) measurements. Cardiotoxicity is recognized as a potential adverse effect for a wide range of drug candidates including chemotherapy drugs but also a number of biologics or new treatments for diabetes to name a few. Including LVP assessments in early stage drug safety testing can strengthen the scientific basis to support compound nomination to later development phases. Functional cardiac safety tests after chronic administration also provide valuable safety data before committing significant resources to clinical trials. While non-clinical QTc evaluations are limited to species that express the appropriate ion channel (i.e. IKr), cardiac function including contractility can be evaluated using a broad range of species. Over the last years, Citoxlab has developed one of the largest historical database in drug cardiac safety screening. Our expertise can facilitate selection of the most appropriate model but also the optimal drug vehicle and treatment regimen for cardiac safety screenings. When follow-up investigations on cardiac contractility are required, various technologies including echocardiography and high definition telemetry are offered to enable longitudinal designs. As appropriate, complete compliance with Good Laboratory Practice for regulatory submission is offered. If you are interest to discuss our latest technologies, come and meet with our team at the Annual Safety Pharmacology Society Meeting in Washington DC from October 19 to 22 or at the Annual meeting of the American College of Toxicology in Orlando, Florida from November 9 to 12. Please contact our team of experts to discuss design of your next cardiac safety testing studies.

Citoxlab now offers the Extended One-Generation Reproductive Toxicity Study (OECD 443 / EOGRTS)

DART homeslideCitoxlab announces that the newly designed Extended One-Generation Reproductive Toxicity Study (published as OECD 443 Test Guideline) is now available at the French and Hungarian sites.

This EOGRTS is a new study design intended to provide a thorough toxicity assessment across life stages by a combined examination of reproductive toxicity, developmental neurotoxicity (DNT), developmental immunotoxicity (DIT), endocrine disruption (including thyroid parameters) and systemic toxicity. In addition, end points are assessed in more offspring than in the classical multi-generation study (i.e. OECD 416) whilst the mating of the second generation (P1) and the second generation offspring (F2) are omitted from the protocol, unless triggered in specific cases. This new EOGRTS protocol is expected to provide a higher level of scientific information and substantial animal use reduction at the same time when no second generation offspring is produced.

With more than 200 reprotoxicology studies performed over the last 7 years (OECD 414, ICH S5, OECD 145, 416, 421 and 422), Citoxlab offers you a wealth of experience for your DART projects, in particular for chemical products.

Citoxlab brings comprehensive and contemporaneous Sprague-Dawley and Wistar rat historical data covering all stages to be assessed in the OECD 443 test guideline: clinical signs, body weight, food consumption (P, F1 and F2 generations), mating and fertility indexes (P, F1 and F2 generations), seminology (P and F1 generations), estrous cycles (P and F1 generations), reproduction data: pregnancy, corpora lutea, pre-/ post-implantation, sex-ratio, parturition, birth, lactation and weaning (P, F1 and F2 generations); developmental data: external/visceral/skeletal examinations, DEXA (bone growth and development), pups reflex and physical development (F1 and F2 generations), hematology /blood biochemistry and urinalysis, histopathology: reproductive organs, central nervous system, lymphoid organs, etc…; neuro-behavioral assessment: FOB, acoustic startle reflex, motor activity, cognitive function, immunology (flow cytometry phenotyping, ELISA, etc…).

Make your batch release testing fast and efficient with Citoxlab in Denmark

Bulle-labo_flow cytoCitoxlab in Denmark recently increased its capacity in performing batch release and biological control/potency tests under GMP for finished pharmaceutical products. You benefit from Citoxlab’s full range of strategies and techniques using a subset of characterization assays to release your formulated product. These tests include batch release, potency tests for human growth hormone (HGH), heparin and other products according to the published monographs (USP, PhEUR) or to the Sponsor’s own methodologies.

The laboratory is GMP certificated and the test results are immediately reported as a certificate issued after completion to ensure fast turnaround and efficient sample data management.

If you have finished products that require batch release testing, we will be very pleased to help you.

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Appointment of Massimiliano Fonsi as Director of DMPK at Citoxlab in France

Bulles emailing sept 7We are pleased to announce that Massimiliano Fonsi, PhD, has joined Citoxlab in France as Director of DMPK. Massimiliano has 15 years’ experience gained in pharmaceutical companies (Merck, UCB Pharma, ADDEX Pharmaceuticals) and CRO (IRBM).

Massimiliano brings experience in advancing compounds to preclinical phase. He was also responsible for designing PK studies to support developmental progression from lead optimization to clinical candidate selection and developing robust PK/PD and efficacy models. In addition, Massimiliano will be interacting with our clients as an expert, advising for the best strategy for the DMPK and related bioanalysis studies. His skills and multicultural experience will very well complement those of the existing staff.

You will have the opportunity to meet Massimiliano and discuss your projects at the upcoming meetings of the GMP (French metabolism and Pharmacokinetics Group, Paris, October 22nd-24th 2014) and the European Bioanalysis Forum (Barcelona, November, 19th-21th 2014).

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Citoxlab doubled capacity for Chicken Eye Irritation testing (ICE)

Bulles suite_2Citoxlab has recently doubled its capacity to perform in vitro eye irritation testing. This standard in vitro test (OECD 438 guideline) is gaining broad acceptance for pharmaceutical, agrochemical, chemical and personal care products for regulatory registration/classification, screening and ranking studies to determine their irritation potential.

The Isolated Chicken Eye test (ICE) is a rapid (4 hours after the exposure) and highly predictive test, with up to 82% accuracy for non-irritants and 86% accuracy for severe eye irritants which is significantly better than any other in vitro test assay. The extent of corneal injury and opacity (closely related with potential for recovery) can be further evaluated by addition of histopathology with this test.

The use of an ophthalmic microscope during observations allows a more detailed understanding of the fine corneal changes. The ICE can in some cases be a stand-alone test for classification purposes.

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Conferences

Bulles news_AOur Citoxlab Teams will be delighted to meet you in September and October during the EUROTOX annual meeting (Edinburgh, UK, 07-10/06/14), the Chemical Industries Regulation: CIR (Barcelona, 09-10/09/14), Life Sciences Baltics (Vilnius, Lithuania, 10-12/09/2014), BioSpain (Santiago de Compostela, Spain, 24-26/09/2014).

You can access the posters presented and all the details about the events