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A RELIABLE PARTNER IN YOUR DISCOVERY
SPECIALIZED INGLP NONCLINICAL RESEARCH
WWW.PRESTIGEBIORESEARCH.COM
PRESTIGE BIORESEARCHAAALAC Accredited GLP Research Laboratories
Prestige BioResearchGLP Laboratories by PWG Genetics
Prestige BioResearch is a Singapore based GLP nonclinical CRO providing comprehensive research services in support of drug
and medical device development to the clients worldwide.
With its proven track record and professional expertise in nonclinical and translational research, Prestige BioResearch became one of the top CROs in Asia off ering GLP regulatory program services as well as a wide variety of effi cacy trials for drugs and medical devices.
Our AAALAC accredited facilities are equipped with animal study rooms of rodents, minipigs, non-human primates, guinea pigs and rabbits, laboratories for clinical pathology, histopathology, cell biology, immunology, chemical analysis, bioanalysis and surgery/imaging suites. OECD and US FDA GLP compliant studies supporting IND, NDA and medical device biocompatibility (ISO10993) are off ered with high scientifi c standards and professionalism.
Professional study management and scientifi c quality ensured by highly trained scientifi c staff including DABT, ACVP, DVMs and PhDs
15 Tech Park Crescent, Singapore 638117
Phone +65 6863 3042Fax +65 6863 4834Email [email protected]@prestigebioresearch.comWeb www.pwg.com.sgwww.prestigebioresearch.com
PRESTIGE BIORESEARCHPHONE +65 6863 3042
On-site Quality Assurance Unit for worldwide GLP compliance
State-of-the-art facilities, equipment, software and GLP data management system to produce top quality study reports
PPrestige BioResearch Singapore
Business MilestonesCertification and Accomplishments
2005
2007
GLPGood Laboratory
Practice
Prestige World Genetics, USA Establishes a Spin-off Company, PWG Genetics Pte Ltd in Singapore
Establishment of PWG Laboratories in Tuas Biomedical Park, Singapore
Singapore AVA Registration as Animal & Biomedical Research Facility
AAALAC Full-accreditation by AAALAC International for World Standard Animal Care System
Establishment of Good Laboratory Practice (GLP) System in Compliance with US FDA
OECD GLP registration by Singapore Accreditation Council (SAC)
AAALAC Accreditation Renewal
Prestige BioResearchSingapore
2009
2010
2011
2012
2013
CRO Business Spin-off as Prestige BioResearch GLP Laboratories
2015
Proven Excellence in Provision of Biomedical Research Services
PRESTIGE BIORESEARCH
GLP General ToxicologyPrestige BioResearch provide GLP general toxicology study services
Plan Study
Study Set-up
Selection of Test SystemDose Level /Administration Route /Frequency / Study Period
Protocol ApprovalPristima Protocol GenerationWork SchedulingTest Article Receipt IACUC
Pre-dose
RandomizationAcclimationVeterinary ExaminationRooms and Equipment Preparation and Validation
In-life
Formulation and DosingScheduled/unscheduled Data Collection Clinical Pathology/Analysis
Post-mortem
Scheduled Data Collection and Sacrifi ceNecropsyHistopathology
Submission of QA Audited Final Report with GLP Compliance Statement and QA Statement
Reporting
Archive
Study Raw DataProtocols / ReportMicroscopic slides and SpecimenTest Articles
RodentsMouse, Rat
Non-HumanPrimatesCynomolgus Monkeys
MinipigPWG Micropig®
ANIMAL SPECIES
Oral Dosing – Gavage, Capsule, Dosed Feed
Dermal Application – Cream, Gel, Ointment – Transdermal Patch
Parenteral Routes – SC, IP, IM and IV bolus – Continuous IV infusion
ADMINISTRATION ROUTE
General Toxicology in Rodents – Acute (OECD 400 series) – 7, 14, 28 Days DRF – 4, 13, 26, 52 Weeks
General Toxicology in Minipigs / NHP – Dose Escalation / MTD – 14, 28 Days DRF – 4, 13, 26, 39, 52 Weeks
TYPES OF STUDY
STUDY FLOW
PRESTIGE BIORESEARCHPHONE +65 6863 3042
Clinical Pathology
Histopathology
* H&E Staining* Masson’s Trichrome Staining * Special Staining * Immunohistochemistry Microscopic Examinations and Peer-Review by Certifi ed Veterinary Pathologists and ACVP
Hematology WBC, RBC, Hb, Hct, MCV, MCH, MCHC, PLT, RDW, CHCM, HDW, MPV, Relative (%) and Absolute (#) value of Granuloc-tyes (Neut, Eos, Baso), Mono, Lympho, Retic and Large Unstained CellsSerum ChemistryAST, ALT, ALP, GLU, Tprot, ALB, BUN, Crea, Trig, TBili, Chol, Ca, P, GGT, Na, K, ClUrinalysis Specifi c gravity, pH, GLU, Bil, KET, BLD, Pro, UBG, NIT, LEUCoagulation PT, APTT, Fibrinogen, Factor Defi ciency, Heparin, vWF
Necropsy
* Gross Observation / Findings* Organ Weight Stations Interfaced with Pristima* Organ/Tissue Collection and Fixation for Histopathology
&St
anda
rd F
ull L
ist
Siemens ADVIA 2120 Analyzer
Siemens Dimension Xpand Plus Clinical Chemistry Analyzer
Siemens Clinitek Advantus Urinalyzer
Siemens Sysmex CA-620 Coagulation System
* Formulation Analysis and Bioanalysis for Chemical and Biologics* Analytical Method Validation* Pharmacokinetics (PK) / Toxicokinetics (TK)* Anti-drug Antibody Analysis and Neutralizing Antibody Analysis
Shimadzu LCMS-8030 Triple Quadrople
Liquid Chromatograph Mass Spectrometer (LCMS/MS)
Shimadzu Prominence Ultra Fast LC (HPLC)
TECAN Sunrise™ ELISA System
Histopathology and Peer Review
PBR’s clinical pathology lab is equipped with high-quality auto-mated equipment and system interfaced with Pristima.
Analytical PK/TK Study
www.PRESTIGEBIORESEARCH.COmPRESTIGE BIORESEARCH
AMES Bacterial Reverse Mutation, OECD 471Chromosomal Aberration, OECD 473 – CHO or V79 (CHL) cells – Human LymphocytesMouse Micronucleus Test, OECD 474Mouse Lymphoma Assay, OECD 476
ICHS7A/B Core BatteryCNS – Irwin BehaviourCV – Minipig and NHP TelemetryRespiration – Whole Body PlethysmographyQT-Prolongation– hERG Assay
Guinea pig – Passive Cutaneous Anaphylaxis (PCA) – Active Systemic Anaphylaxis (ASA) – Skin Sensitization, OECD 406 – Guinea Pig Maximization Test – Buehler Repeated Patch TestRabbit – Skin Irritation, OECD 404 – Eye Irritation, OECD 405
Fertility StudyTeratogenicity, OECD 414Peri- and Postnatal Study, OECD 414One Generation Reproduction Toxicity, OECD 415Two Generation Reproduction Toxicity, OECD 416
Antigenicity& Local Irritation
ReproductiveToxicology
Carcino- genicity
Short Term Carcinogenicity – Transgenic Mouse, 6 months2 Year Bioassay in RodentsCombined Chronic/Carcinogenicity
Genetic Toxicology
SafetyPharmacology
PRESTIGE BIORESEARCHPHONE +65 6863 3042
Micropig is the most suitable model for dermal studies and wound healing.
* Dermal toxicology: single dose to up to 52 weeks repeated dose on cream, gel, ointment or transdermal patches* Skin irritation study* Wound healing study* Investigative studies to evaluate skin therapy or product
8
Special Toxicology
Dermal Studies and Wound Healing
Juvenile Study in Minipigs
Minipig is advantageous for reproductive toxicology due to large litter size. Segment 1 and 2 reproductive toxicology can be conducted in minipigs and recommended for drugs unfi t for rodent or rabbit studies due to metabolic profi le.
* Required for pediatric indications* Possible in all routes of administration* Advantageous at PBR in terms of juvenile animal availability and experimental skills in Micropig
* Special acclimation to reduce weaning stress and training for study procedures and handling* Enhanced environmental enrichment
Minipig Reproductive Toxicology
n
L
www.PRESTIGEBIORESEARCH.COmPRESTIGE BIORESEARCH
GLP Computer System
Prestige BioResearch
uses the most up-to-date
computer GLP system
Software in compliance
with worldwide GLP
Regulations
Archive
GLP Data management system, Pristima (US FDA CFR 21 Part 11 compliant) from Xybion Medical Systems, USA.
Quality Assurance
PBR’s on site Quality Assurance Unit (QAU) ensures compliance to worldwide GLP requirements.
Audit to ensure completeness and accuracy of study adhering to GLP requirements
Study audits on critical phases and overall conduct of study
Procedural audits for repeated study procedures as well as facility audits to ensure overall compliance
PBR’s GLP Archives are operated in accordance with documented SOPs with stringent environmental and security control.
GLP Document Archive
Test Article Reserve
Specimen Archive for Wet Tissues, Paraffi n Blocks and Microscopic Slides
Animal Room – Animal Assignment and Data Collection
Clinical Pathology
Necropsy – Organ Weight and Lists
Pathology – Gross Finding – Microscopic Examination – Peer Review
Reproductive toxicology
Study Design – Protocol Setup / Approval – Schedule Activities
Statistical Analysis and Report – Data Management – Archive
PBR ensures the best scientifi cand GLP qualityin all studies
Animal Rooms with Environmental Control
PRESTIGE BIORESEARCHPHONE +65 6863 3042
www.PRESTIGEBIORESEARCH.COm
Effi cacy and DiscoveryUsing Micropig Disease Models
A variety of human disease models can be created in pigs via chemical or dietary induction as well as genetic modifi cations. PWG has developed unique Micropig disease models to off er the customized effi cacy trials in GLP settings.
&
Surgical Induction
Osteoarthritis - Degeneration of joint cartilage and the underlying bone by meniscectomyBone, Cartilage, Skin defect models
Chemical Induction
Diabetes - Streptozotocin (STZ)-induced diabetic Micropig modelParkinson’s Disease - MPTP-induced Parkinsonism Micropig modelRheumatoid Arthritis - Collagen-induced Rheumatoid arthritis Micropig modelAchondroplasia - The fi rst mammalian dwarfi sm (Achondroplasia) Micropig model
Dietary and Combined
Atherosclerosis - High fat & high cholesterol dietHyperlipidemia - High fat & high cholesterol dietHypertension - Nephrectomy and high sodium dietOsteoporosis - Ovariectomy and low Calcium diet
Others Transgenic Micropigs
PRESTIGE BIORESEARCH
Medical Device Evaluation & Trainingwith professional veterinary surgery, care and diagnostic services
GastrointestinalDevices
Orthopedic Implants
CardiovascularDevices
Dental Implants
Tissues and Organ RegenerationDevice /Therapy
Anesthesia & MonitoringVascular & Peritoneal CatheterizationPre and Post-op Care
PBR’s surgical suites are equipped with anesthesia units, physiology monitor, C-arm X-ray and ultrasound enabling on-site imaging, angiography and echocardiography.
Medical training for various types of medical devices and therapy can be conducted at PBR.
PRESTIGE BIORESEARCHPHONE +65 6863 3042
ISO10993-4 Hemocompatibility
* Hemolysis* Prothrombin Time* Partial Thromboplastin Time* Complement Activation* Platelet Aggregation & Count* Platelet Activation* in vivo Thrombogenicity
www.PRESTIGEBIORESEARCH.COm
Biocompatibility testing is required for the registration of medical devices that come into contact with body and now required to be conducted under GLP.
Medical Device Biocompatibility TestISO10993 Biocompatibility Series under GLP
ISO10993-3 Genotoxicity
* AMES Test (Bacterial Reverse Mutation Test)* Mouse Lymphoma Assay* Mouse Micronucleus Test* Chromosome Aberration
ISO10993-6 Implantation
* Acute * Sub-acute (Sub-chronic)* Chronic
ISO10993-5 Cytotoxicity
* MEM Elution* Agar Diffusion* MTT Evaluation* Colony Formation
ISO10993-10Sensitization & Irritation
* Guinea Pig Maximization Test* Buehler’s Repeated Patch Test* Local Lymphnode Assay* Primary Skin Irritations
ISO10993-11 Systemic Toxicity & Pyrogenicity
* Acute * Sub-acute (Sub-chronic)* Chronic* Rabbit Pyrogenicity
Prestige BioResearch offers full series ISO10993 studies in compliance with US FDA and OECD GLP.
PRESTIGE BIORESEARCH
Bio-imaging CentreThe state of the art, one-stop Imaging Services
COPYRIGHT © 2014-2015 PRESTIGE BIORESEARCH PTE LTD ALL RIGHTS RESERVED
* SPF PWG Micropig® * Whole Blood * Serum * Plasma * Skin (Fresh/Frozen) * Organs and Tissues * Hepatocytes * Liver Microsome * S9 Fraction
Specialty Research
BSL-3 equivalent Laboratory
&
Air-tight sealed BSL-3 equivalent laboratory is equipped with animal isolators, fume hood, necropsy station and auxiliary lab instruments for conducting hazardous agent challenge or exposure experiments in large animals. Exhaust air is fi ltered by NBC fi lter to meet the standards in CBRNe research.
Siemens 1.5T MRIShimadzu High Resolution SMX-100CT Micro-CT E Vista Micro PETGenoray C-arm X-Ray Radio/FluoroscopyGE Healthcare Logiq C5 Premium UltrasoundEchocardiographyAngiography
Combined with the well designed operation theatres and surgery services, Prestige BioResearch can provide a one-stop research services in medical device evaluation and effi cacy studies.
Bioresource SupplyPWG Micropigs and research material of laboratory animal species are available for distribution.