Actualités de Citoxlab – Décembre 2016

accellabCitoxlab acquires AccelLAB, a Canadian CRO specialized in pre-clinical assessment of medical devices

Earlier in November, Citoxlab announced the acquisition of AccelLAB, a Canadian CRO specializing in the preclinical testing of new medical devices. Through this acquisition, Citoxlab Group reinforces its position as a major non-clinical CRO player, as we expand our service portfolio to include medical devices, a fast growing area offering great synergies potential with drug development, one of Citoxlab’s core businesses.

AccelLAB was founded in 2004 by Dr. Guy Leclerc, an interventional cardiologist who headed the Department of Cardiology and Cardiac Surgery at the Centre Hospitalier de l’Université de Montreal (CHUM). Dr Leclerc has been a pioneer in applying what we today call translational research in the field of medical devices, helping clients in the development of new cardiac stents, valves, pacemakers, etc. Over the years, the services were expanded to other areas such as orthopedic, ENT (Ear, Nose and Throat) and dermatology specialties.

AccelLAB has over 100 staff, and the facilities include operating rooms, in particular for high definition fluoroscopy guided cardiac catheterization, state-of-the-art laboratories, a large vivarium, a medical imaging department (scanning and MRI) and clinical pathology and histopathology laboratories.

Dr. Jean-François Le Bigot, Chairman and CEO of Citoxlab Group stated: “We identified AccelLAB as a strategic partner to make our Group a more global player in the life sciences services arena. Within the Citoxlab Group, AccelLAB allows the convergence between the development of new drugs and medical devices, representing a new area of specialty services to our customers”.

With this acquisition, Citoxlab continues its growth strategy and becomes a group with more than 1,000 staff in 4 countries (France, Canada, Hungary and Denmark), and revenues over €100 million.

bulles-nl-novembre-5Citoxlab’s Wide-ranging Expertise in Ocular Safety Evaluation

Assessment of retinal function in the evaluation of possible toxicity can be performed by electroretinography (ERG), a standard clinical method of measuring the functional responses of retinal cells.

Our state-of-the-art ERG procedures are in full compliance with Good Laboratory Practice (GLP) and are also aligned with clinical recommendations for this assay, which can be performed in small and medium-sized animals (e.g. rabbits, dogs, minipigs and monkeys). Under the supervision of our team of veterinary ophthalmologists, ERG data acquisition is undertaken by a team of specialized staff.

In addition to this functional investigation, Optical Coherence Tomography (OCT) has also been developed at Citoxlab to complete the panel of tests that can be used for early drug safety assessments. OCT is a non-invasive imaging technique that captures high-resolution images of the retina and optic nerve. These images provide information that is useful for the investigation of the posterior or anterior segment of the eye, and is complementary to histopathological evaluation during drug exposure. In addition to routine histopathological techniques and enhanced evaluation by step-sectioning or immunohistochemistry, sampling of different compartments and layers of the eye at necropsy can be performed for further post-mortem investigations (e.g. genomics, electron microscopy).

We offer in-depth ophthalmology safety investigations at our sites in North America, France and Denmark.

genomicsGood Clinical Practice Compliance for Sample Analysis in Support of Clinical Programs

Citoxlab in France (Evreux) is pleased to announce that the site is now fully compliant with Good Clinical Practice (GCP), opening the opportunity for customers to use our comprehensive bioanalytical, biomarker, and immunogenicity services for the analysis of clinical samples. Our Quality Assurance program and dedicated processes have been modified as required by the GCPs, and in particular a Sample Manager has been appointed as well as a Data Privacy Officer to guarantee full traceability and anonymity of samples with due respect to data privacy, with the systematic use of pseudonymized data during the entire bioanalytical process.

Considering the historical Good Laboratory Practice (GLP) compliance at both of our French sites (Evreux and Atlanbio in Saint-Nazaire), this provides a unique opportunity for our customers to generate high quality data both in support of preclinical and clinical programs, making Citoxlab the partner of choice for translational research activities.

These services include molecular biology and genomics activities (qPCR or semi-quantitative RT-PCR, including miRNA analyses, gene expression profiling, genotyping and next generation sequencing technologies), as well as immunoassays (including bioanalysis, anti-drug antibodies (ADA) and soluble biomarkers), histology and immunohistochemistry or in situ hybridization (ISH), and the evaluation of the humoral and cellular immune responses in clinical samples.

bulles-nl-novembre-4Measuring Plasma Levels of Citrulline by LC-MS/MS in Gottingen Minipigs and Rhesus Monkeys as a Biomarker for Gastrointestinal-Acute Radiation Syndrome

Citrulline, a non-coded amino acid, is produced almost exclusively by the enterocytes of the small intestine in all species. Clinically, citrullinemia is used as a simple, sensitive and suitable biomarker for gastrointestinal injury. Leveraging high throughput platforms, Citoxlab has developed a robust historical database using citrullinemia across a wide range of non-clinical species for use in drug development.

A protein precipitation extraction assay and by high performance liquid chromatography with mass spectrometric detection (LC-MS/MS) method for the determination of endogenous citrulline levels in Rhesus monkey plasma (K3EDTA) and Gottingen minipig plasma (K2EDTA) was qualified at our Citoxlab North America facility, in support of a preclinical program assessing the effect of radiation exposure. Method qualification included linearity (1.00 to 50.00 µg/mL), matrix screening for endogenous citrulline levels, sensitivity, precision and accuracy (intra-assay and inter-assay), processed sample integrity, and various stability evaluations in Rhesus monkey and Gottingen minipig plasma.

The data generated demonstrated that the method allowed for a sensitive quantitation of GI integrity in support of non-clinical programs. Importantly, our historical data enable improved interpretation by comparison of species specific differences in the kinetics of citrulline changes.

bulles-nl-novembre-3QT interval correction for drugs which induce changes in body temperature

We have recently published a case study in which a new drug candidate produced significant and dose-dependent increases in QT interval duration in a GLP regulatory toxicology study involving cardiovascular safety assessment by jacketed external telemetry in dogs. The effects on QT interval were observed without any effect on the in vitro hERG channel test. However, dose-dependent decreases in body temperature were observed, along with increases in QT interval duration, corrected for heart rate according to the Van de Water formula (QTcV); the effect was no longer observed after correction for changes in Body Temperature (BT) according to the Van der Linde formula : BT [QTcVcT = QTcV – 14(37.5 – BT)].

The data have been published in the Journal of Pharmacological and Toxicological Methods (QT interval correction for drug-induced changes in body temperature during integrated cardiovascular safety assessment in regulatory toxicology studies in dogs: a case study, El Amrani et al. 81: 136- 143, 2016.)

We recommend that the evaluation of potential effects of drug candidates on body temperature should be performed when investigating potential cardiovascular effects. Ignoring this correction for body temperature may lead to a misinterpretation of changes in corrected QT for heart rate in preclinical and clinical investigations.

atlanbioAtlanbio Appoints Mark Warren as Scientific Director

Atlanbio, a Citoxlab Group company, specializing in preclinical and clinical bioanalysis, announces that Mark Warren has joined the France-based company as Scientific Director after 12 years in North America, managing preclinical and clinical research bioanalysis units.

Graduated from McGill University (Montreal, Canada) in human and animal metabolism, specializing in mass spectrometry and stable isotopes, Mark has worked for international Contract Research Organizations (CRO) including Charles River Laboratories (Canada), MDS Pharma (Canada), Alta/Intertek Pharmaceutical Services (CA,USA), PRA International/Health Services (KS,USA) and Lambda Therapeutic Research Inc. (Canada).

As Scientific Director, Mark is part of the atlanbio Test Facility Management team, working with Jacques Girault (Managing Director) and Philippe Couerbe (CEO), thereby strengthening the management team following a 25% increase in sales in 2015. Based at the Saint-Nazaire facility, he will be developing the company’s mass spectrometry expertise in therapeutic proteins and biomarkers, with a particular focus on the implementation of hybrid techniques for immunogenicity and chromatography.

bulles-nl-novembre-2New Pathologists in Citoxlab North America

Dr. Rémi Froment graduated from the École Nationale Vétérinaire de Lyon (France) in 2009. He started his residency training in Veterinary Clinical Pathology at the University of Montréal (Québec) in 2011, and became Board Certified by the American College of Veterinary Pathology (clinical pathology) in September 2014. Since then, he has been working in the diagnostic field both in Europe and North America before joining the Pathology group at our North American facility.

bulles-nl-novembreDr. Christiana Glover is DVM and PhD. In 2002, she started her MVSc/Residency in Veterinary Anatomic Pathology at the University of Prince Edward Island (UPEI) in the Atlantic Veterinary College (AVC) in Charlottetown, Canada. After her MVSc/Residency in Veterinary Anatomic Pathology, she moved to Montreal in 2005 to work at ITR Laboratories Canada Inc. as a Veterinary Pathologist. In 2010, she attained Board Certification in Veterinary Anatomic Pathology by the American College of Veterinary Pathologists and was promoted to Senior Veterinary Pathologist in 2011. She has 11 years’ experience as a Toxicologist Pathologist evaluating and interpreting slides for GLP and non-GLP studies on a variety of species including rodents, rabbits, dogs, minipigs and non-human primates. Dr. Glover is a member of a number of professional associations including the American College of Veterinary Pathologists, Society of Toxicological Pathologists and British Society of Toxicologists.

conferencesConferences

The Citoxlab team would be delighted to meet you at the following scientific meetings:

> Pharma Outsourcing:
December 8
Stockholm, Sweeden
CLICKING HERE

> Beltox Annual Meeting:
December 9
Louvain-La-Neuve, Belgium
CLICKING HERE

> 48th Annual Symposium of the Society of Toxicology of Canada (STC)
December 4-6
Ottawa, Canada
CLICKING HERE

Presentation: “Trends with Non-Clinical and In-vitro Models for Proarrhythmia and Seizure Assessments” by Simon Authier (Senior Director, Scientific Operations and Veterinary Services)