Prestige BioResearch

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


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

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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

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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


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

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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

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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


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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.

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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


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.


ISO10993-4 Hemocompatibility

* Hemolysis* Prothrombin Time* Partial Thromboplastin Time* Complement Activation* Platelet Aggregation & Count* Platelet Activation* in vivo Thrombogenicity

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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.


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.

Prestige BioResearch

Documents

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