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2021Company Introduction
ANAPATH
AnaPath is a global contract research organization (CRO) and pathology services company that
provides preclinical and bioanalytical R&D solutions. AnaPath is the result of the merger
between two companies: AnaPath Services, based in Switzerland and specializing in pathology,
and AnaPath Research, based in Barcelona and focused on preclinical development.
AnaPath Services emerged from RCC/Harlan and was established in 2013. It is located close
to the pharmaceutical capital Basel and has quickly developed into a globally recognized
company owing to its expertise. AnaPath Services is well known for its scientific competence
in toxicologic pathology, fast turnaround times and reliability.
AnaPath Research was founded in 1980 as Cidasal. Over the years the company has been
part of various multinational corporations, such as RCC, Harlan and Envigo, providing high
quality services to our sponsors at all times. At the end of 2019, AnaPath Services acquired
the site to continue together the journey towards excellence in research.
As of November 2020, AnaPath operates a liaison office in Korea. The site is headed by CEO
Guk Jin Son, a respected partner of AnaPath for many years. Through AnaPath Korea, our
Asian clients are supported throughout the drug development process. AnaPath Korea
facilitates constant and clear communication between the client and the scientific experts
at AnaPath, thus ensuring the proper development of the projects.
AnaPath’s different departments work in perfect coordination to support the pharmaceutical,
chemical, agrochemical and veterinary industries. The facilities have GLP (Good Laboratory
Practice) certification and studies are performed in compliance with national and international
regulatory guidelines.
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Index
General Toxicology 6
Analytical & Bioanalytical Services 8
Quality Assurance 10
Animal Welfare Body 10
Clinical Sciences & Sample Management 11
Veterinary Services 12
Animal House 13
Necropsy & Histology 16
Pathology 17
Molecular Pathology 18
Special Technologies 19
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Proud of our track record, we provide solutions backed by years of experience.
General ToxicologyGeneral Toxicology - rodents and
non-rodents
• Single-dose administration
• Pharmacokinetics and toxicokinetics
• Maximum-tolerated-dose studies
• Repeat-dose administration (sub-acute, sub-chronic and chronic studies)
• Carcinogenicity studies
Safety Pharmacology Studies
• Effects on cardiovascular and respiratory system – telemetric measurements
• Central nervous system assessment (Modified Irwin test, FOB)
• Supplementary safety studies
• A variety of tailored animal model studies
Developmental and Reproductive Toxicology (DART)
• Reproduction/developmental toxicity screening
• Fertility and Early Embryonic Development
• Embryo-Fetal Development
• Pre- and Postnatal Development
• Multigenerational studies
• Extended One Generation
• Juvenile Toxicity
General Toxicology performs a full
range of studies to support the
pharmaceutical, chemical,
agrochemical and veterinary
industries.
Our team consists of senior scientists
with an average of 20 years of
experience in toxicology,
pharmacokinetics and safety
pharmacology, and wide knowledge
of the current regulatory guidelines.
We offer scientific advice on study
types, study design and choice of dose
levels before starting with first-in-
human trials.
As a GLP-certified and AAALAC-
accredited center, we fully embrace the
3Rs of animal welfare. We are strongly
convinced that our animal welfare
policies have a positive impact on our
studies.
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Non-rodent StudiesOur in-house expertise of more than 30
years working with NHP and dog
species allows us to offer a full range of
standard general toxicology,
pharmacology and pharmacokinetics
studies, apart from more tailored
studies depending on the sponsor’s
needs.
With more than 15 years of
experience, implantable and jacket
telemetry provides quality results
and meets the regulatory
requirements for pre-clinical testing.
Our location in the bioregion of
Catalonia gives us the added
advantage of being able to
effortlessly liaise with partners in
the area to perform specific
procedures.
Over the years we have worked with
a full range of different kinds of
products, including monoclonal
therapy, biosimilar and vaccinal
products.
Non-human Primate Studies
Our highly trained staff is able to perform a full range ofdifferent techniques. Here are some highlights:
• 1-hour infusion administration (includingaudiovisual enrichment during theprocedure)
• Juvenile toxicology studies
• Liver biopsies
• Telemetry of blood pressure, ECG and respiratory data in freely moving primates
• Anesthetized NHP models for specific molecule requirements; blood flow, dP/dT, blood gas measurements and a variety of vascular cannulations and surgical pharmacology procedures
Our experienced technicians are fully trained in the assessment of Central Nervous System in NHP, as part of toxicology or standalone studies, performing Functional Observation Battery.
Dog Studies
Owing to our vast experience in dog studies, we offer a wide range of studies including, but not limited to, the following techniques:
• Blood extraction from jugular, cephalic or saphenous veins
• Urinary bladder cannulation for urine collection
• Unrestrained dogs (implantable and jacket telemetry) to evaluate safety pharmacology core battery of cardiovascular and respiratory systems
• Up to 6-hour infusion administration (unrestrained method)
Analytical & Bioanalytical ServicesBioanalysis
• Bioanalysis for NCE supported by LC-MS/MS
• Analysis of macromolecules using ligand binding assays (non-clinical and clinical)
• Biologics supported by immunoassay platforms and LC-MS/MS
AnaPath’s bioanalytical team will
support your project all the way from
drug discovery, through preclinical
development and up to the clinical
phase. Whether it is method
development or routine sample
analysis, we are dedicated to
providing accurate, reliable and
streamlined bioanalytical services for
the most challenging programs to
help you make confident research
decisions.
Immunogenicity testing
• Determination of anti-drug antibodies (ADA) using ligand binding assays
• Titration assays using ligand binding assays
• Neutralizing antibody (nAb) assays
Biomarker determination
• Assistance to evaluate scientifically and biologically relevant biomarkers
• Biomarker determination in preclinical and clinical phases of drug development
• Development and qualification of novel biomarkers
• Fit-for-purpose GLP validation of established qualified assays
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Flow cytometry testing
• Immunophenotyping in blood and organs
• Receptor occupancy assays
• Cellular response assays
Molecular biology
• Non-clinical study program for GTMP to properly assess the benefits and risks of such products when used in humans
• Nucleic acid-based therapeutic assessments, including biodistribution/shedding studies and quantitation of transgene mRNA for gene and cell therapies
• Gene expression analysis in blood and organs
• Separated qPCR facilities to prevent cross-contamination
Dose formulation analysis
• To confirm the correct dosing in in vivo studies and to support toxicology, genotoxicity and reprotoxicology by HPLC-UV/Vis and LC-MS/MS
Equipment
Real Time PCR (qPCR) Mx3005P (Stratagene)
HPLC (Waters)-API 4000TM (Sciex)
UPLC (Waters)-API 4000TM (Sciex)
UPLC (Waters)-API 5000TM (Sciex)
UPLC (Waters)-Triple Quad 6500+TM (Sciex)
BD FACSCanto™ II (3 lasers – 6 color configurations) (BD)
ELISA Spectramax 190C Microplate reader - UV mode
(Molecular Devices)
ELISA M3 Microplate reader - UV, fluorescence,
luminescence mode (Molecular Devices)
HPLC-UV/VIS, diode-array (DAD), fluorescence detectors
(Waters)
GxP systems
Softmax Pro GxP v 5.4.1 (Molecular Devices)
FACS Diva v8 (BD)
Mx Pro ET v4.10 (Strategene)
Analyst v1.4.2, v1.6.2 and v1.6.3 (Sciex)
Empower v2.0 (Waters)
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Quality AssuranceAnaPath is certified in Good Laboratory Practice and has three Compliance Programs:
• Pharmaceutical, veterinary and cosmetic products, and medical device
• Agrochemical products
• Chemicals and food additives for human use
Being one of the first CROs to receive
GLP certification in the bioregion of
Spain, our Quality Assurance Unit
works to maintain and improve the
quality system to guarantee that the
studies performed at AnaPath comply
with the highest quality standards.
Our team of auditors have more than
15 years of experience in the field.
Animal WelfareBody
The Animal Welfare Body is an
indispensable component in a
research center like ours that uses
animals.
Its aim is to ensure that all experimental
procedures performed at AnaPath
comply with the current legislation and
to evaluate all procedures involving
animals.
As an AAALAC-accredited institution
since 2016, AnaPath Research fully
embraces the 3Rs of animal welfare
(replacement, refinement and
reduction). We are convinced that our
animal welfare policies have a positive
impact on our studies.
Animal Welfare Body is made up of:
• Animal Welfare Advisor
• One researcher
• One experienced scientist acting as an
external delegate
• A representative from the Quality Assurance
Unit not involved in the procedures acting as
an in-house delegate
• Head of Animal House
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Clinical Sciences & Sample Management
AnaPath offers a wide range of clinical
sciences research services, including
the development of novel analytical
methods supported by a strong
expertise in the field.
We employ robust technologies
including industry gold standard
methodologies. Our processes and
data are managed via LIMS providing
high standards of quality control.
We perform test plasma and serum
biochemistry panels: full hematology
evaluation, including cell
morphology assessment, and urine
chemistry.
Through effective and efficient
processes, our team delivers
excellent support on sample
management procedures for cells,
plasma, serum, urine, among
others.
Biochemistry
AnaPath offers a standard biochemistry panel for the
different species used in preclinical studies and a wide
panel of biomarkers to meet our customer's needs.
• Cobas 6000 analyzer series delivers high quality
results based on experience, innovation and
advanced technologies
• Cobas u411 urine analyzer measures a wide range of
parameters
• Semi-automated gel electrophoresis instrument,
HYDRASYS, provides a complete test panel with high
sensitivity and good resolution
Hematology
AnaPath offers a standard hematology and hemostasis
panel for the different species used in preclinical studies.
• Advia 120 & 2120 flow cytometry–based system uses
light scatter, differential white blood cell (WBC) lysis,
and myeloperoxidase and oxazine 750 staining to
provide a complete blood cell count, a WBC
differential, and a reticulocyte count. A cyanide-free
method is used to measure hemoglobin
colorimetrically. In addition to its capability for
analyzing peripheral blood specimens, the analyzer is
also equipped to analyze cerebrospinal fluid samples.
• STA Compact Max® is a fully automatic coagulation
analyzer. The instrument utilizes barcoding of test
reagents, calibrators and controls.
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Veterinary Services
The Veterinary Services Department
consists of the Veterinary Unit and
the Animal Welfare Unit.
Our main objective is to care for the
animals and their welfare in the best
possible way, making the quality of
the experimental system optimal for
the great variety of studies that we
carry out.
We have extensive experience in all
the species we work with, so we also
offer a veterinary advisory service to
AnaPath's team of researchers, as
well as actively participate in the
ongoing training of our animal
technicians and in the refinement of
experimental techniques.
Veterinary Unit
Animal health control
• Responsible for veterinary inspections and animal
health, scheduling and coordinating routine
prophylactic procedures
• Applying humane endpoints and ensuring the
correct application of animal welfare policies
• Managing animal adoption program (re-homing)
Control of the Animal House environmental conditions
• Scheduling, managing and reviewing microbiological
controls, water quality, light levels and air changes in
the animal facilities, as well as supervising diets and
bedding analysis
Animal Welfare Unit
Animal welfare control
• Establishing and improving the Animal Care and
Welfare Program and inspections for all species
• Establishing humane endpoints and ensuring
compliance with animal welfare policies
• Performing statistics of animal use at AnaPath
Research and reporting all animal-welfare-related
issues to the Animal Welfare Body
Consulting and training
• Ensuring continuous training for the Animal House
staff as well as Study Directors in animal care and
welfare-related matters, in the recognition of limiting
clinical signs and humane endpoints
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AnimalHouse
The Animal House is the core of
AnaPath scientific activity. Over the
years, the department has evolved
and adapted to changes in legislation
and animal welfare
recommendations to minimize
animal stress, which, together with
our staff’s experience, guarantees
quality experimental results.
The AH team is duly accredited in
accordance with the current
legislation and has vast experience
in most of the species detailed in
Annex II of the order
ECC/566/2015.
Thanks to continuous training and
teamwork, our AH can perform a
great amount of techniques and
experimental procedures with the
reliability and efficiency expected
by our customers.
Species
We have wide experience working with all the species
contemplated in the current legislation as well as target
species of veterinary products.
• rat • mouse • guinea pig
• rabbit • NHP • dog
• cat • minipig • hamster
Specific techniques
We have broad experience performing an array of
specific experimental procedures.
• Clinical and behavioral observations
• Modified Irwin test: rodent
• Functional Observation Battery (FOB): rodent,
NHP, dog, cat
• Mating: rodent, rabbit
• Postnatal evaluation: rat
• ECGs with snapshots and jackets: NHP, dog, cat,
minipig
• Blood pressure: NHP, dog
• Intraocular pressure: rabbit, dog Administration routes
We offer a variety of administration routes and the
experience of our technicians guarantees correct praxis.
• oral (gavage, diet,
capsules and tablets)
• intravenous (bolus,
infusion)
• subcutaneous • intramuscular
• intraperitoneal • dermal/intradermal
• ocular • intravaginal/intrarectal
• nasogastric (in NHPs) • intranasal (in rodents
and cats)
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AH1 AreaRodents and Rabbits
AH1 Rodents and rabbits
Rodents (14 rooms)
• rats: 80-450 animals/room
• mice: 185-400 animals/room
• guinea pigs: 70-200 animals/room
Rabbits (10 rooms)
• 5 rooms of 27 animals each
• 5 rooms of 39 animals each
AH2 NHP
NHP (7 rooms)
• Cages/room: 3-13
• Animals/cage: 3-7
AH3 Dogs, cats and minipigs
Dogs (14 rooms)
• 7 rooms of 32 animals each
• 7 rooms of 16 animals each
• 1 telemetry room of 6 animals
Cats (7 rooms)
• Freely housed animals/room: 32
• Animals/cage: 3-4
Minipigs (7 rooms)
• Animals/room: 16
Animals are housed in different areas,
depending on the species:
• AH1: rodents and rabbits
• AH2: NHP
• AH3: dogs, cats, minipigs
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Capabilities
AH2 AreaNHP
AH3 AreaCats, Dogs and
Minipigs
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Necropsy & Histology
This service to General Toxicology
is provided jointly by the local
Pathology Department, headed by
an ECVP Board Certified
Pathologist and the integrated
capacity of AnaPath Services.
AnaPath Services is a specialized
CRO, renown and unique in its
expertise of and dedication to
toxicologic histopathology.
The team consists of over 25
skilled technicians, cross-trained
and harmonized in both necropsy
techniques and histological
processing.
Six qualified and highly experienced
pathologists, headed by Dr. Klaus Weber,
DJSTP,providesufficientcapacity toadjust
totighttimelines ifnecessary.
Necropsy service - rodents and
non-rodentsRoutine studies, standard and special trimming: RITA,
Young, Sagartz and other schemas as required
Studies with special sampling requirements:
• Organ sampling, e.g. for qPCR, IHC on frozen or
formalin-fixed tissue, ophthalmic studies
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Histotechnique - rodents and
non-rodents
• Capacity of 45’000 H&E stained tissues per month
• Other routinely used stains: PAS, Perls’ Prussian
Blue, Oil Red O, Alcian Blue, May-Grünwald Giemsa,
Sirius-Red, Fluoro-Jade, Azan, Methylgreen-
Pyronin, etc.
• Neuropathology processing
• Plastic/resin/hard material embedding
• 100% QC check of histological slides
• Hight throughput slide scanning
Pathology Our pathologists are renown
scientists with up to 35 years of
experience. They are trained in all
laboratory animals, rodents and
non-rodents, and other species
including but not limited to fish,
frog, snails, worms and birds. Their
publication record is impressive
and rare for a CRO. It reflects the
hundreds of thousands of tissues
evaluated combined with scientific
excellence and outstanding
attention to detail.
Certification of our pathologist Dr.
Klaus Weber by the Japanese
Society of Toxicologic Pathology is
another indication of our global
scientific recognition. The level of
our expert knowledge in
oncogenicity studies,
neuropathology, inhalation
pathology, sperm and ovary
staging, bone marrow evaluation
or cardiovascular pathology is rare
to find.
Histopathological examination
• Toxicologic pathology
• Fetal pathology
• Medical device pathology
• Experimental Pathology
• Molecular pathology
• Peer reviews
• Tumor analysis
• 3D culture evaluation
• Evaluation of electron micrographs, EDX analysis,
hyperspectral microscopy, laser scanning and digital
microscopy
• Training in machine learning programs for automated
histomorphometric analysis
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Ecotoxicology and endocrine disruptor
Fast processing and evaluation of ecotoxicology studies in
frog, snail, earthworm and fish owing to our huge capacity.
NASH, fibrosis, lung histopathology
AnaPath provides tailored examination based on our
experience.
As an example, for NASH we can deliver the usual Nash
score read out or the extended AnaPath NASH scoring
system.
Semiquantitative analysis of NASH score can be
supported by quantitative image analysis tailored for the
respective needs, measuring cellular structures like
vacuole parameter (steatosis), collagen (fibrosis) and
inflammatory/immune cells to quantify lobular
inflammation.
Molecular Pathology
The Molecular Pathology Department
of AnaPath has more than 15 years of
experience in biomarker analysis for
pre-clinical development.
Our experienced pathologists and
cell/molecular biologists will
support you to answer the critical
questions. We can select from a
portfolio of established biomarkers
and technologies to choose the
best approach for your preclinical
study. The list of available
biomarkers is continuously
expanding.
Furthermore, we offer FISH and
qPCR analysis using CE/IVD-
certified instruments. This
technique allows us to provide
additional molecular analyses, such
as gene expression, identification
of mutations, SNP genotyping and
detection of infectious diseases.
Immunohistochemistry
The fully automated Leica BOND-III system operated by
experienced technicians secures reliable and constant
staining results on fresh frozen or FFPE samples
Efficient IHC staining protocol development based on
experience with numerous established biomarkers
Conduction of IHC studies under GLP or non-GLP
including qualitative/semiquantitative evaluation by an
experienced pathologist or quantitative image analysis
by computer-assisted tools
Tissue cross-reactivity studies
GLP compliant TCR analysis of therapeutic monoclonal antibodies on human tissue panels following FDA and EMA requirements
All tissue samples evaluated by a pathologist prior to study start to guarantee human tissue panels of the highest quality
Furthermore, TCR might help to understand similarities and differences of drug target localization and expression between species
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Quantitative real time PCR (qPCR)
Gene expression analysis to have a better understanding of drug’s mechanism of action. Can be combined with Laser Capture Microdissection to analyze specific regions within a tissue section
Mutation analysis to predict risk of disease, identify targeted treatments and anticipate drug response
Single nucleotide polymorphism (SNP) analysis (genotyping) to provide relevant information on susceptibility to diseases
Detection and quantification of infectious pathogens within an investigated sample
Special Technologies
AnaPath a myriad of technologies for
special evaluation and for solving
unusual challenges in pathology. We
have established a large variety of
measurements for quantitative data to
provedifferentendpoints.
Experienced scientists and
pathologists can also help making a
series of customized
measurements, designed to
demonstrate special endpoints
specific to your device.
Imaging and microscopic technologies
• Scanning electron microscopy (SEM)
• Energy dispersive x-ray analysis (EDX)
• 3D confocal laser scanning microscopy
• Digital microscopy
• Hyperspectral microscopy
• Laser capture microscopy
• Artificial intelligence-driven image analysis
• Slide scanning up to 100X magnification
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In Anapath, we have worked with all types of molecules, including:
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MoleculeExpertise
Biomolecules
• Vaccines (mRNA, AADvac, others)
• ADCs
• Alarelin
• DNA aptamer
• LongLasting Insulines
• Long Lasting Glucagon
• Long Lasting EPO
• Exendin
• Monoclonal antibodies , including biosimilars(Denosumab, Tocilizumab, Avastin, Etanercept)
• hGF
• Interferons
• Clexane (anti Xa /anti IIa)• Ciclosporin
• Argyrin F
• Pidotimod
• Alarelin
• Salinomycin
• Octreotide
• Vancomycin
• Colistin
NCE
• Bilastine
• LMWH
• Cannabinoids
• Opiates
• Risperidone
• Dexamethasone
• MTX
• Antibiotics (Rifampicin, Penicillin, others)
• Metamizole
• Praziquantel
• Fenbendazole
• Oxfendazole
• Acadesine
• ZMP
• Risperidone
• Lipochroman-6
• ZTP
• CBPI
• Olanzapine
• Tetrazicar
• Diclazuril
• Cypermethrin
• Domperidone
• Flubendazole
• Ibudilast
• Sulfadiazine
• Trimethoprim
• Topiramate
• Dexamethasone
• Sulfadimidine
• Doxycycline
• 5-methylthioadenosine (MTA)
• Paclitaxel
• 2-Hydroxyoleic Acid
• Genistein
• Doxorubicin
• 2'Fucosyllactose
• Brinzolamide
• Chloranfenicol
• Tiamulin
• Penicillin G
• Phoxim
• Amoxicillin
• Spectinomycin
• lincomycin
• Dihydrospectinomycin
• Oxytetracycline
• Closantel
• mebendazol
• Benzylpenicillin
• Ketoprofen
• Tilmicosin
• Albendazol
• Meloxicam
• Ceftiofur
• Tylosin
• Chlorfenvinphos
• Butaphosphan
• Darifenacin
• Clenbuterol
• Desoxypeganin
• Difenoconazole
• Dopamine
• Fenbutatin
• Acethylcholine
• Choline
• Dopac
• Bumetanide
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Back to the origin,and fly high
ContactAnaPath Research, Spainanapathresearch.com
Centro Industrial Santigac/Argenters, 608130 Santa Perpètua de MogodaBarcelona / Spain
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Ctra. Castellar del Vallès a SentmenatC-1415a, km 2908211 Castellar del VallèsBarcelona / Spain
AnaPath Services, Switzerlandanapath.ch
Hammerstrasse 494410 LiestalSwitzerland
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AnaPath Services, Koreaanapath.ch
Guk-Jin [email protected]
Shin [email protected]
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